Trial Outcomes & Findings for SBRT With Immunotherapy in Early Stage Non-small Cell Lung Cancer: Tolerability and Lung Effects (NCT NCT03383302)
NCT ID: NCT03383302
Last Updated: 2026-07-17
Results Overview
Number of participants with grade ≥ 3 pneumonitis from treatment with nivolumab after stereotactic body radiotherapy (SBRT) within 6 months of the final fraction of SBRT (2-3 weeks treatment duration depending on dosing). A rate that exceeds 20% will be deemed unacceptable and will lead to a rejection of the null hypothesis.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
36 participants
Primary outcome timeframe
Six months from final dose of SBRT (2-3 weeks) administered for each patient
Results posted on
2026-07-17
Participant Flow
Thirty-six patients were registered into the study from the Royal Marsden site between February 2018 and January 2024. However, only 31 were eligible and of which 29 started study treatment.
Of 36 registered participants, 31 met inclusion criteria and were eligible for study treatment.
Participant milestones
| Measure |
Arm 1 Tolerability
This is a single arm study of nivolumab administered on completion of stereotactic body radiotherapy (SBRT) to patients with early stage NSCLC. The first 5 patients to enroll must have Eastern Co-operative Oncology Group (ECOG) performance status \< 2 at the time of first dose of investigational medical product (IMP). An Independent Data Monitoring Committee (IDMC) will meet when the first 5 patients have reached 3 months follow up from their 1st dose of nivolumab or have withdrawn consent to follow-up. The IDMC, if satisfied with the safety data from the initial 5 patients, may recommend escalation to include recruitment of patients with ECOG performance status of 2.
Stereotactic body radiotherapy: Patients will receive a total of 54 Gy if delivered in 3 fractions, 55 Gy if delivered in 5 fractions or 60 Gy if delivered in 8 fractions.
Nivolumab: Nivolumab is a human immunoglobulin G4 (IgG4) monoclonal antibody, that binds to the PD-1 receptor and blocks interaction with its ligands PD-L1 and PD-L2. Nivolumab will be administered intravenously at a flat dose of 240 mg q2w over 30 minutes for 13 cycles followed by 480mg q4w over 60 minutes for 7 cycles, until 20 cycles in total to complete (a minimum of 1 year of treatment if no delays are encountered).
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|---|---|
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Overall Study
STARTED
|
31
|
|
Overall Study
Received SBRT treatment
|
30
|
|
Overall Study
Received Nivolumab treatment (Primary analysis population)
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29
|
|
Overall Study
Completed study treatment
|
6
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
Arm 1 Tolerability
This is a single arm study of nivolumab administered on completion of stereotactic body radiotherapy (SBRT) to patients with early stage NSCLC. The first 5 patients to enroll must have Eastern Co-operative Oncology Group (ECOG) performance status \< 2 at the time of first dose of investigational medical product (IMP). An Independent Data Monitoring Committee (IDMC) will meet when the first 5 patients have reached 3 months follow up from their 1st dose of nivolumab or have withdrawn consent to follow-up. The IDMC, if satisfied with the safety data from the initial 5 patients, may recommend escalation to include recruitment of patients with ECOG performance status of 2.
Stereotactic body radiotherapy: Patients will receive a total of 54 Gy if delivered in 3 fractions, 55 Gy if delivered in 5 fractions or 60 Gy if delivered in 8 fractions.
Nivolumab: Nivolumab is a human immunoglobulin G4 (IgG4) monoclonal antibody, that binds to the PD-1 receptor and blocks interaction with its ligands PD-L1 and PD-L2. Nivolumab will be administered intravenously at a flat dose of 240 mg q2w over 30 minutes for 13 cycles followed by 480mg q4w over 60 minutes for 7 cycles, until 20 cycles in total to complete (a minimum of 1 year of treatment if no delays are encountered).
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|---|---|
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Overall Study
Death
|
4
|
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Overall Study
Deterioration in health
|
2
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Overall Study
Withdrawal by Subject
|
1
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Overall Study
Lost to Follow-up
|
4
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Baseline Characteristics
Data collected for 30 participants - 1 withdrew before data could be collected.
Baseline characteristics by cohort
| Measure |
Arm 1 Tolerabilty
n=31 Participants
This is a single arm study of nivolumab administered on completion of stereotactic body radiotherapy (SBRT) to patients with early stage NSCLC. The first 5 patients to enroll must have Eastern Co-operative Oncology Group (ECOG) performance status \< 2 at the time of first dose of investigational medical product (IMP). An Independent Data Monitoring Committee (IDMC) will meet when the first 5 patients have reached 3 months follow up from their 1st dose of nivolumab or have withdrawn consent to follow-up. The IDMC, if satisfied with the safety data from the initial 5 patients, may recommend escalation to include recruitment of patients with ECOG performance status of 2.
Stereotactic body radiotherapy: Patients will receive a total of 54 Gy if delivered in 3 fractions, 55 Gy if delivered in 5 fractions or 60 Gy if delivered in 8 fractions.
Nivolumab: Nivolumab is a human immunoglobulin G4 (IgG4) monoclonal antibody, that binds to the PD-1 receptor and blocks interaction with its ligands PD-L1 and PD-L2. Nivolumab will be administered intravenously at a flat dose of 240 mg q2w over 30 minutes for 13 cycles followed by 480mg q4w over 60 minutes for 7 cycles, until 20 cycles in total to complete (a minimum of 1 year of treatment if no delays are encountered).
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|---|---|
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Age, Continuous
|
73.0 years
n=31 Participants
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Sex: Female, Male
Female
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18 Participants
n=31 Participants
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Sex: Female, Male
Male
|
13 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=31 Participants
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|
Race (NIH/OMB)
Asian
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
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2 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
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0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=31 Participants
|
|
Region of Enrollment
United Kingdom
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31 participants
n=31 Participants
|
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Smoking status
Current smoker
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4 Participants
n=31 Participants
|
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Smoking status
Ex-smoker
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25 Participants
n=31 Participants
|
|
Smoking status
Never smoker
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2 Participants
n=31 Participants
|
|
ECOG Performance Status
ECOG 0
|
7 Participants
n=31 Participants
|
|
ECOG Performance Status
ECOG 1
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18 Participants
n=31 Participants
|
|
ECOG Performance Status
ECOG 2
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6 Participants
n=31 Participants
|
|
Type of NSCLC
Adenocarcinoma
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24 Participants
n=30 Participants • Data collected for 30 participants - 1 withdrew before data could be collected.
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|
Type of NSCLC
Not Otherwise Specified
|
1 Participants
n=30 Participants • Data collected for 30 participants - 1 withdrew before data could be collected.
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Type of NSCLC
Squamous
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5 Participants
n=30 Participants • Data collected for 30 participants - 1 withdrew before data could be collected.
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|
Stage at diagnosis
IA
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16 Participants
n=30 Participants • Data collected for 30 participants - 1 withdrew before data could be collected.
|
|
Stage at diagnosis
IB
|
11 Participants
n=30 Participants • Data collected for 30 participants - 1 withdrew before data could be collected.
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|
Stage at diagnosis
IIA
|
2 Participants
n=30 Participants • Data collected for 30 participants - 1 withdrew before data could be collected.
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Stage at diagnosis
IIB
|
1 Participants
n=30 Participants • Data collected for 30 participants - 1 withdrew before data could be collected.
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|
Single or synchronous disease
Single
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27 Participants
n=30 Participants • Data collected for 30 participants - 1 withdrew before data could be collected.
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Single or synchronous disease
Synchronous
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3 Participants
n=30 Participants • Data collected for 30 participants - 1 withdrew before data could be collected.
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|
Site of disease
Left Lower Lobe
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4 Participants
n=30 Participants • Data collected for 30 participants - 1 withdrew before data could be collected.
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Site of disease
Left Upper Lobe
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8 Participants
n=30 Participants • Data collected for 30 participants - 1 withdrew before data could be collected.
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|
Site of disease
Lingular
|
1 Participants
n=30 Participants • Data collected for 30 participants - 1 withdrew before data could be collected.
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|
Site of disease
Right Lower Lobe
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7 Participants
n=30 Participants • Data collected for 30 participants - 1 withdrew before data could be collected.
|
|
Site of disease
Right Middle Lobe
|
1 Participants
n=30 Participants • Data collected for 30 participants - 1 withdrew before data could be collected.
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Site of disease
Right Upper Lobe
|
9 Participants
n=30 Participants • Data collected for 30 participants - 1 withdrew before data could be collected.
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PRIMARY outcome
Timeframe: Six months from final dose of SBRT (2-3 weeks) administered for each patientPopulation: The primary analysis population consists of all eligible patients who received at least one dose of Nivolumab following the final fraction of SBRT, which will include 29/31 eligible patients.
Number of participants with grade ≥ 3 pneumonitis from treatment with nivolumab after stereotactic body radiotherapy (SBRT) within 6 months of the final fraction of SBRT (2-3 weeks treatment duration depending on dosing). A rate that exceeds 20% will be deemed unacceptable and will lead to a rejection of the null hypothesis.
Outcome measures
| Measure |
Arm 1 Tolerabilty
n=29 Participants
This is a single arm study of nivolumab administered on completion of stereotactic body radiotherapy (SBRT) to patients with early stage NSCLC. The first 5 patients to enroll must have Eastern Co-operative Oncology Group (ECOG) performance status \< 2 at the time of first dose of investigational medical product (IMP). An Independent Data Monitoring Committee (IDMC) will meet when the first 5 patients have reached 3 months follow up from their 1st dose of nivolumab or have withdrawn consent to follow-up. The IDMC, if satisfied with the safety data from the initial 5 patients, may recommend escalation to include recruitment of patients with ECOG performance status of 2.
Stereotactic body radiotherapy: Patients will receive a total of 54 Gy if delivered in 3 fractions, 55 Gy if delivered in 5 fractions or 60 Gy if delivered in 8 fractions.
Nivolumab: Nivolumab is a human immunoglobulin G4 (IgG4) monoclonal antibody, that binds to the PD-1 receptor and blocks interaction with its ligands PD-L1 and PD-L2. Nivolumab will be administered intravenously at a flat dose of 240 mg q2w over 30 minutes for 13 cycles followed by 480mg q4w over 60 minutes for 7 cycles, until 20 cycles in total to complete (a minimum of 1 year of treatment if no delays are encountered).
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|---|---|
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Assessment of Lung Toxicity (Pneumonitis) From Treatment With Nivolumab After SBRT for Early Stage NSCLC
|
0 Participants
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SECONDARY outcome
Timeframe: 24 months from last dose of SBRT (2-3 weeks treatment duration)Population: All eligible patients who received at least one dose of nivolumab treatment and at least one fraction of SBRT will be included for the secondary endpoints analysis of safety and tolerability of nivolumab after SBRT, and for toxicity assessment of exploratory endpoints, which will include 29/31 eligible patients.
Rates of toxicity will be summarised as worst toxicity grade during treatment as per CTCAE v. 4 after treatment with Nivolumab following SBRT.
Outcome measures
| Measure |
Arm 1 Tolerabilty
n=29 Participants
This is a single arm study of nivolumab administered on completion of stereotactic body radiotherapy (SBRT) to patients with early stage NSCLC. The first 5 patients to enroll must have Eastern Co-operative Oncology Group (ECOG) performance status \< 2 at the time of first dose of investigational medical product (IMP). An Independent Data Monitoring Committee (IDMC) will meet when the first 5 patients have reached 3 months follow up from their 1st dose of nivolumab or have withdrawn consent to follow-up. The IDMC, if satisfied with the safety data from the initial 5 patients, may recommend escalation to include recruitment of patients with ECOG performance status of 2.
Stereotactic body radiotherapy: Patients will receive a total of 54 Gy if delivered in 3 fractions, 55 Gy if delivered in 5 fractions or 60 Gy if delivered in 8 fractions.
Nivolumab: Nivolumab is a human immunoglobulin G4 (IgG4) monoclonal antibody, that binds to the PD-1 receptor and blocks interaction with its ligands PD-L1 and PD-L2. Nivolumab will be administered intravenously at a flat dose of 240 mg q2w over 30 minutes for 13 cycles followed by 480mg q4w over 60 minutes for 7 cycles, until 20 cycles in total to complete (a minimum of 1 year of treatment if no delays are encountered).
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|---|---|
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Adverse Events (Toxicity) by Worst Grade
Grade 3
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16 Participants
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|
Adverse Events (Toxicity) by Worst Grade
Grade 1
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1 Participants
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|
Adverse Events (Toxicity) by Worst Grade
Grade 2
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11 Participants
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|
Adverse Events (Toxicity) by Worst Grade
Grade 4
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1 Participants
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SECONDARY outcome
Timeframe: Within 16 weeks of each patient commencing treatment with Nivolumab after SBRT (2-3 weeks duration)Population: All eligible patients who received at least one dose of nivolumab treatment and at least one fraction of SBRT will be included for the secondary endpoints analysis of safety and tolerability of nivolumab after SBRT, and for toxicity assessment of exploratory endpoints, which will include 29/31 eligible patients.
The proportion of patients receiving 1,2,3,4,5 and 6 doses within 16 weeks of commencing treatment are reported with a 95% exact confidence interval.
Outcome measures
| Measure |
Arm 1 Tolerabilty
n=29 Participants
This is a single arm study of nivolumab administered on completion of stereotactic body radiotherapy (SBRT) to patients with early stage NSCLC. The first 5 patients to enroll must have Eastern Co-operative Oncology Group (ECOG) performance status \< 2 at the time of first dose of investigational medical product (IMP). An Independent Data Monitoring Committee (IDMC) will meet when the first 5 patients have reached 3 months follow up from their 1st dose of nivolumab or have withdrawn consent to follow-up. The IDMC, if satisfied with the safety data from the initial 5 patients, may recommend escalation to include recruitment of patients with ECOG performance status of 2.
Stereotactic body radiotherapy: Patients will receive a total of 54 Gy if delivered in 3 fractions, 55 Gy if delivered in 5 fractions or 60 Gy if delivered in 8 fractions.
Nivolumab: Nivolumab is a human immunoglobulin G4 (IgG4) monoclonal antibody, that binds to the PD-1 receptor and blocks interaction with its ligands PD-L1 and PD-L2. Nivolumab will be administered intravenously at a flat dose of 240 mg q2w over 30 minutes for 13 cycles followed by 480mg q4w over 60 minutes for 7 cycles, until 20 cycles in total to complete (a minimum of 1 year of treatment if no delays are encountered).
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|---|---|
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Proportion of Patient Receiving 1,2,3,4,5 and 6 Doses of Nivolumab Within 16 Weeks of Commencing Adjuvant Nivolumab After SBRT for Early Stage NSCLC
Received 1 dose
|
1.00 proportion of participants
Interval 0.88 to 1.0
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Proportion of Patient Receiving 1,2,3,4,5 and 6 Doses of Nivolumab Within 16 Weeks of Commencing Adjuvant Nivolumab After SBRT for Early Stage NSCLC
Received 2 doses
|
0.90 proportion of participants
Interval 0.73 to 0.98
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Proportion of Patient Receiving 1,2,3,4,5 and 6 Doses of Nivolumab Within 16 Weeks of Commencing Adjuvant Nivolumab After SBRT for Early Stage NSCLC
Received 3 doses
|
0.83 proportion of participants
Interval 0.64 to 0.94
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Proportion of Patient Receiving 1,2,3,4,5 and 6 Doses of Nivolumab Within 16 Weeks of Commencing Adjuvant Nivolumab After SBRT for Early Stage NSCLC
Received 4 doses
|
0.79 proportion of participants
Interval 0.6 to 0.92
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|
Proportion of Patient Receiving 1,2,3,4,5 and 6 Doses of Nivolumab Within 16 Weeks of Commencing Adjuvant Nivolumab After SBRT for Early Stage NSCLC
Received 5 doses
|
0.79 proportion of participants
Interval 0.6 to 0.92
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Proportion of Patient Receiving 1,2,3,4,5 and 6 Doses of Nivolumab Within 16 Weeks of Commencing Adjuvant Nivolumab After SBRT for Early Stage NSCLC
Received 6 doses
|
0.76 proportion of participants
Interval 0.56 to 0.9
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SECONDARY outcome
Timeframe: 24 months from last dose of SBRT (2-3 weeks duration)Population: All eligible patients who received at least one fraction of SBRT will be included for all other secondary endpoints and exploratory endpoints related to survival, relapse rates and HRQoL, which will include 30/31 eligible patients.
All rates of relapse (local, loco-regional and distant rates) were evaluated using the 30 patients in the efficacy population and presented as a proportion with a 95% exact binomial confidence interval. Time to event analysis was not performed within these endpoints as the number of events were too low.
Outcome measures
| Measure |
Arm 1 Tolerabilty
n=30 Participants
This is a single arm study of nivolumab administered on completion of stereotactic body radiotherapy (SBRT) to patients with early stage NSCLC. The first 5 patients to enroll must have Eastern Co-operative Oncology Group (ECOG) performance status \< 2 at the time of first dose of investigational medical product (IMP). An Independent Data Monitoring Committee (IDMC) will meet when the first 5 patients have reached 3 months follow up from their 1st dose of nivolumab or have withdrawn consent to follow-up. The IDMC, if satisfied with the safety data from the initial 5 patients, may recommend escalation to include recruitment of patients with ECOG performance status of 2.
Stereotactic body radiotherapy: Patients will receive a total of 54 Gy if delivered in 3 fractions, 55 Gy if delivered in 5 fractions or 60 Gy if delivered in 8 fractions.
Nivolumab: Nivolumab is a human immunoglobulin G4 (IgG4) monoclonal antibody, that binds to the PD-1 receptor and blocks interaction with its ligands PD-L1 and PD-L2. Nivolumab will be administered intravenously at a flat dose of 240 mg q2w over 30 minutes for 13 cycles followed by 480mg q4w over 60 minutes for 7 cycles, until 20 cycles in total to complete (a minimum of 1 year of treatment if no delays are encountered).
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|---|---|
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Disease Relapse - To Assess Local, Local-regional and Distant Disease Relapse Rates
Local relapse
|
0.03 Proportion of participants
Interval 0.001 to 0.17
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Disease Relapse - To Assess Local, Local-regional and Distant Disease Relapse Rates
Loco-regional relapse
|
0.03 Proportion of participants
Interval 0.001 to 0.17
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|
Disease Relapse - To Assess Local, Local-regional and Distant Disease Relapse Rates
Distant relapse
|
0.07 Proportion of participants
Interval 0.01 to 0.22
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|
Disease Relapse - To Assess Local, Local-regional and Distant Disease Relapse Rates
Any relapse
|
0.13 Proportion of participants
Interval 0.04 to 0.31
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SECONDARY outcome
Timeframe: Overall survival rate (OS) at 12 and 24 monthsPopulation: All eligible patients who received at least one fraction of SBRT will be included for all other secondary endpoints and exploratory endpoints related to survival, relapse rates and HRQoL, which will include 30/31 eligible patients. 1 patient out of the 30 eligible for this analysis could not be included as they withdrew during RT treatment and no RT start date was recorded. 29 patients were analysed.
Overall survival (OS) was evaluated for 29 out of the 31 patients in the efficacy population (1 patient withdrew during SBRT and no SBRT start date was recorded) OS rates at 12 and 24 months are reported.
Outcome measures
| Measure |
Arm 1 Tolerabilty
n=29 Participants
This is a single arm study of nivolumab administered on completion of stereotactic body radiotherapy (SBRT) to patients with early stage NSCLC. The first 5 patients to enroll must have Eastern Co-operative Oncology Group (ECOG) performance status \< 2 at the time of first dose of investigational medical product (IMP). An Independent Data Monitoring Committee (IDMC) will meet when the first 5 patients have reached 3 months follow up from their 1st dose of nivolumab or have withdrawn consent to follow-up. The IDMC, if satisfied with the safety data from the initial 5 patients, may recommend escalation to include recruitment of patients with ECOG performance status of 2.
Stereotactic body radiotherapy: Patients will receive a total of 54 Gy if delivered in 3 fractions, 55 Gy if delivered in 5 fractions or 60 Gy if delivered in 8 fractions.
Nivolumab: Nivolumab is a human immunoglobulin G4 (IgG4) monoclonal antibody, that binds to the PD-1 receptor and blocks interaction with its ligands PD-L1 and PD-L2. Nivolumab will be administered intravenously at a flat dose of 240 mg q2w over 30 minutes for 13 cycles followed by 480mg q4w over 60 minutes for 7 cycles, until 20 cycles in total to complete (a minimum of 1 year of treatment if no delays are encountered).
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|---|---|
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Overall Survival
12 month OS rate
|
100 Percentage of participants
All patients were alive at 12 months. Confidence interval could not be computed.
|
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Overall Survival
24 month OS rate
|
89 Percentage of participants
Interval 70.0 to 96.0
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SECONDARY outcome
Timeframe: Disease Free Survival (DFS) at 6, 12 and 24 monthsPopulation: All eligible patients who received at least one fraction of SBRT will be included for all other secondary endpoints and exploratory endpoints related to survival, relapse rates and HRQoL, which will include 30/31 eligible patients. Twenty-nine patients were included in the disease-free survival analysis, 1 patient out of the 30 eligible for this analysis could not be included as they withdrew during RT treatment and no RT start date was recorded.
Disease-free survival (DFS) was evaluated for 29 out of the 31 patients in the efficacy population (1 patient withdrew during SBRT and no SBRT start date was recorded) DFS rates at 6, 12 and 24 months are reported.
Outcome measures
| Measure |
Arm 1 Tolerabilty
n=29 Participants
This is a single arm study of nivolumab administered on completion of stereotactic body radiotherapy (SBRT) to patients with early stage NSCLC. The first 5 patients to enroll must have Eastern Co-operative Oncology Group (ECOG) performance status \< 2 at the time of first dose of investigational medical product (IMP). An Independent Data Monitoring Committee (IDMC) will meet when the first 5 patients have reached 3 months follow up from their 1st dose of nivolumab or have withdrawn consent to follow-up. The IDMC, if satisfied with the safety data from the initial 5 patients, may recommend escalation to include recruitment of patients with ECOG performance status of 2.
Stereotactic body radiotherapy: Patients will receive a total of 54 Gy if delivered in 3 fractions, 55 Gy if delivered in 5 fractions or 60 Gy if delivered in 8 fractions.
Nivolumab: Nivolumab is a human immunoglobulin G4 (IgG4) monoclonal antibody, that binds to the PD-1 receptor and blocks interaction with its ligands PD-L1 and PD-L2. Nivolumab will be administered intravenously at a flat dose of 240 mg q2w over 30 minutes for 13 cycles followed by 480mg q4w over 60 minutes for 7 cycles, until 20 cycles in total to complete (a minimum of 1 year of treatment if no delays are encountered).
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|---|---|
|
Disease Free Survival
6 month DFS
|
97 percentage of participants
Interval 78.0 to 99.0
|
|
Disease Free Survival
12 month DFS
|
93 percentage of participants
Interval 75.0 to 98.0
|
|
Disease Free Survival
24 month DFS
|
85 percentage of participants
Interval 65.0 to 94.0
|
SECONDARY outcome
Timeframe: 24 months from last dose of SBRT (2-3 weeks duration)Population: Quality of life was evaluated using the 30 patients in the efficacy population. The number of participants analysed reduces with time due to factors such as death, withdrawals and loss to follow-up.
Estimation of the health-related quality of life (HRQoL) score at each time point of analysis (screening, then at 3, 6, 9, 12, 18, 24 months post-SBRT). QOL questionnaires will be scored according to the EORTC Quality of Life Questionnaire (QLQ-C30) version 3 scoring manual. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level, in cases of a functioning scale a better outcome, but for symptom scales a higher score represents a worse outcome.
Outcome measures
| Measure |
Arm 1 Tolerabilty
n=30 Participants
This is a single arm study of nivolumab administered on completion of stereotactic body radiotherapy (SBRT) to patients with early stage NSCLC. The first 5 patients to enroll must have Eastern Co-operative Oncology Group (ECOG) performance status \< 2 at the time of first dose of investigational medical product (IMP). An Independent Data Monitoring Committee (IDMC) will meet when the first 5 patients have reached 3 months follow up from their 1st dose of nivolumab or have withdrawn consent to follow-up. The IDMC, if satisfied with the safety data from the initial 5 patients, may recommend escalation to include recruitment of patients with ECOG performance status of 2.
Stereotactic body radiotherapy: Patients will receive a total of 54 Gy if delivered in 3 fractions, 55 Gy if delivered in 5 fractions or 60 Gy if delivered in 8 fractions.
Nivolumab: Nivolumab is a human immunoglobulin G4 (IgG4) monoclonal antibody, that binds to the PD-1 receptor and blocks interaction with its ligands PD-L1 and PD-L2. Nivolumab will be administered intravenously at a flat dose of 240 mg q2w over 30 minutes for 13 cycles followed by 480mg q4w over 60 minutes for 7 cycles, until 20 cycles in total to complete (a minimum of 1 year of treatment if no delays are encountered).
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|---|---|
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Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Global Health Status: 18 months PSBRT
|
58 score on a scale
Interval 17.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Global Health Status: 24 months PSBRT
|
67 score on a scale
Interval 17.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Physical functioning: Screening
|
80 score on a scale
Interval 53.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Physical functioning: 3 month PSBRT
|
80 score on a scale
Interval 40.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Physical functioning: 9 month PSBRT
|
67 score on a scale
Interval 13.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Physical functioning: 12 month PSBRT
|
70 score on a scale
Interval 13.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Physical functioning: 15 month PSBRT
|
53 score on a scale
Interval 27.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Physical functioning: 18 month PSBRT
|
80 score on a scale
Interval 7.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Physical functioning: 24 month PSBRT
|
73 score on a scale
Interval 13.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Role functioning: Screening
|
83 score on a scale
Interval 0.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Role functioning: 6 months PSBRT
|
67 score on a scale
Interval 0.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Role functioning: 9 months PSBRT
|
83 score on a scale
Interval 17.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Role functioning: 12 months PSBRT
|
67 score on a scale
Interval 0.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Emotional functioning: Screening
|
92 score on a scale
Interval 33.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Emotional functioning: 3 month PSBRT
|
92 score on a scale
Interval 25.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Emotional functioning: 12 month PSBRT
|
75 score on a scale
Interval 0.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Emotional functioning: 15 month PSBRT
|
75 score on a scale
Interval 0.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Emotional functioning: 18 month PSBRT
|
75 score on a scale
Interval 17.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Emotional functioning: 24 month PSBRT
|
75 score on a scale
Interval 8.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Cognitive functioning: Screening
|
83 score on a scale
Interval 50.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Cognitive functioning: 3 month PSBRT
|
92 score on a scale
Interval 33.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Cognitive functioning: 6 month PSBRT
|
83 score on a scale
Interval 0.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Cognitive functioning: 9 month PSBRT
|
83 score on a scale
Interval 33.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Cognitive functioning: 12 month PSBRT
|
83 score on a scale
Interval 17.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Cognitive functioning: 15 month PSBRT
|
83 score on a scale
Interval 0.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Cognitive functioning: 18 month PSBRT
|
75 score on a scale
Interval 17.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Cognitive functioning: 24 month PSBRT
|
67 score on a scale
Interval 17.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Social functioning: Screening
|
92 score on a scale
Interval 33.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Social functioning: 6 month PSBRT
|
75 score on a scale
Interval 33.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Social functioning: 9 month PSBRT
|
83 score on a scale
Interval 17.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Social functioning: 15 month PSBRT
|
83 score on a scale
Interval 0.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Social functioning: 18 month PSBRT
|
67 score on a scale
Interval 17.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Social functioning: 24 month PSBRT
|
67 score on a scale
Interval 0.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Fatigue: Screening
|
22 score on a scale
Interval 0.0 to 56.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Fatigue: 3 month PSBRT
|
22 score on a scale
Interval 0.0 to 78.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Fatigue: 6 month PSBRT
|
33 score on a scale
Interval 0.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Fatigue: 12 month PSBRT
|
33 score on a scale
Interval 0.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Fatigue: 15 month PSBRT
|
33 score on a scale
Interval 0.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Fatigue: 18 month PSBRT
|
33 score on a scale
Interval 0.0 to 67.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Fatigue: 24 month PSBRT
|
44 score on a scale
Interval 0.0 to 78.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Nausea and vomiting: Screening
|
0 score on a scale
Interval 0.0 to 17.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Nausea and vomiting: 6 month PSBRT
|
0 score on a scale
Interval 0.0 to 67.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Nausea and vomiting: 9 month PSBRT
|
0 score on a scale
Interval 0.0 to 17.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Nausea and vomiting: 12 month PSBRT
|
0 score on a scale
Interval 0.0 to 50.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Nausea and vomiting: 15 month PSBRT
|
0 score on a scale
Interval 0.0 to 50.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Nausea and vomiting: 18 month PSBRT
|
0 score on a scale
Interval 0.0 to 33.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Pain: 3 month PSBRT
|
0 score on a scale
Interval 0.0 to 83.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Pain: 6 month PSBRT
|
0 score on a scale
Interval 0.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Pain: 9 month PSBRT
|
17 score on a scale
Interval 0.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Pain: 12 month PSBRT
|
33 score on a scale
Interval 0.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Pain: 15 month PSBRT
|
0 score on a scale
Interval 0.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Pain: 18 month PSBRT
|
17 score on a scale
Interval 0.0 to 83.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Pain: 24 month PSBRT
|
0 score on a scale
Interval 0.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Dyspnea: Screening
|
33 score on a scale
Interval 0.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Dyspnea: 3 month PSBRT
|
33 score on a scale
Interval 0.0 to 33.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Dyspnea: 6 month PSBRT
|
33 score on a scale
Interval 0.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Dyspnea: 9 month PSBRT
|
33 score on a scale
Interval 0.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Dyspnea: 12 month PSBRT
|
33 score on a scale
Interval 0.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Dyspnea: 15 month PSBRT
|
33 score on a scale
Interval 0.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Dyspnea: 24 month PSBRT
|
33 score on a scale
Interval 0.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Insomnia: Screening
|
0 score on a scale
Interval 0.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Insomnia: 3 month PSBRT
|
0 score on a scale
Interval 0.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Insomnia: 6 month PSBRT
|
33 score on a scale
Interval 0.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Insomnia: 9 month PSBRT
|
33 score on a scale
Interval 0.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Insomnia: 12 month PSBRT
|
33 score on a scale
Interval 0.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Insomnia: 15 month PSBRT
|
33 score on a scale
Interval 0.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Insomnia: 18 month PSBRT
|
17 score on a scale
Interval 0.0 to 67.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Insomnia: 24 month PSBRT
|
33 score on a scale
Interval 0.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Appetite Loss: Screening
|
0 score on a scale
Interval 0.0 to 67.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Appetite Loss: 3 month PSBRT
|
0 score on a scale
Interval 0.0 to 67.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Appetite Loss: 6 month PSBRT
|
33 score on a scale
Interval 0.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Appetite Loss: 9 month PSBRT
|
0 score on a scale
Interval 0.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Appetite Loss: 12 month PSBRT
|
0 score on a scale
Interval 0.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Appetite Loss: 15 month PSBRT
|
33 score on a scale
Interval 0.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Appetite Loss: 18 month PSBRT
|
0 score on a scale
Interval 0.0 to 67.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Appetite Loss: 24 month PSBRT
|
0 score on a scale
Interval 0.0 to 67.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Constipation: Screening
|
0 score on a scale
Interval 0.0 to 67.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Constipation: 3 month PSBRT
|
0 score on a scale
Interval 0.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Constipation: 6 month PSBRT
|
0 score on a scale
Interval 0.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Constipation: 9 month PSBRT
|
0 score on a scale
Interval 0.0 to 33.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Constipation: 12 month PSBRT
|
0 score on a scale
Interval 0.0 to 67.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Constipation: 18 month PSBRT
|
0 score on a scale
Interval 0.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Constipation: 24 month PSBRT
|
0 score on a scale
Interval 0.0 to 67.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Diarrhea: 3 month PSBRT
|
0 score on a scale
Interval 0.0 to 67.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Diarrhea: 6 month PSBRT
|
0 score on a scale
Interval 0.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Diarrhea: 9 month PSBRT
|
0 score on a scale
Interval 0.0 to 67.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Diarrhea: 12 month PSBRT
|
0 score on a scale
Interval 0.0 to 67.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Diarrhea: 15 month PSBRT
|
0 score on a scale
Interval 0.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Diarrhea: 18 month PSBRT
|
0 score on a scale
Interval 0.0 to 67.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Diarrhea: 24 month PSBRT
|
0 score on a scale
Interval 0.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Financial Difficulties: 3 month PSBRT
|
0 score on a scale
Interval 0.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Financial Difficulties: 6 month PSBRT
|
0 score on a scale
Interval 0.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Financial Difficulties: 9 month PSBRT
|
0 score on a scale
Interval 0.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Financial Difficulties: 15 month PSBRT
|
0 score on a scale
Interval 0.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Financial Difficulties: 18 month PSBRT
|
0 score on a scale
Interval 0.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Financial Difficulties: 24 month PSBRT
|
0 score on a scale
Interval 0.0 to 67.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Global Health Status: Screening
|
67 score on a scale
Interval 33.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Global Health Status: 3 months PSBRT
|
67 score on a scale
Interval 25.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Global Health Status: 6 months PSBRT
|
63 score on a scale
Interval 0.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Global Health Status: 9 months PSBRT
|
67 score on a scale
Interval 0.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Global Health Status: 12 months PSBRT
|
67 score on a scale
Interval 17.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Global Health Status: 15 months PSBRT
|
67 score on a scale
Interval 25.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Physical functioning: 6 month PSBRT
|
73 score on a scale
Interval 13.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Role functioning: 3 months PSBRT
|
83 score on a scale
Interval 33.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Role functioning: 15 months PSBRT
|
67 score on a scale
Interval 0.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Role functioning: 18 months PSBRT
|
67 score on a scale
Interval 0.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Role functioning: 24 months PSBRT
|
20 score on a scale
Interval 0.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Emotional functioning: 6 month PSBRT
|
83 score on a scale
Interval 0.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Emotional functioning: 9 month PSBRT
|
83 score on a scale
Interval 42.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Social functioning: 3 month PSBRT
|
83 score on a scale
Interval 0.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Social functioning: 12 month PSBRT
|
67 score on a scale
Interval 0.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Fatigue: 9 month PSBRT
|
22 score on a scale
Interval 0.0 to 89.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Nausea and vomiting: 3 month PSBRT
|
0 score on a scale
Interval 0.0 to 33.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Nausea and vomiting: 24 month PSBRT
|
0 score on a scale
Interval 0.0 to 33.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Pain: Screening
|
0 score on a scale
Interval 0.0 to 67.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Dyspnea: 18 month PSBRT
|
33 score on a scale
Interval 0.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Constipation: 15 month PSBRT
|
0 score on a scale
Interval 0.0 to 100.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Diarrhea: Screening
|
0 score on a scale
Interval 0.0 to 33.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Financial Difficulties: Screening
|
0 score on a scale
Interval 0.0 to 67.0
|
|
Health-related Quality of Life (HRQoL) Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC
EORTC QLQ-C30 Financial Difficulties: 12 month PSBRT
|
0 score on a scale
Interval 0.0 to 100.0
|
SECONDARY outcome
Timeframe: 24 months from last dose of SBRT (2-3 weeks)Population: Quality of life was evaluated using the 30 patients in the efficacy population. The number of participants analysed reduces with time due to factors such as death, withdrawals and loss to follow-up.
Estimation of HRQoL in patients treated with Nivolumab after SBRT for early stage NSCLC using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) at each time point of analysis (screening, then at 3, 6, 9, 12, 18, 24 months post-SBRT). QOL data will be scored according to the QLQ-LC13 scoring manual, which includes one multi-item scale to assess dyspnea, and a series of single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and haemoptysis, all had a score ranging from 0 to 100, where a higher score represents a high level of symptomatology/problems.
Outcome measures
| Measure |
Arm 1 Tolerabilty
n=30 Participants
This is a single arm study of nivolumab administered on completion of stereotactic body radiotherapy (SBRT) to patients with early stage NSCLC. The first 5 patients to enroll must have Eastern Co-operative Oncology Group (ECOG) performance status \< 2 at the time of first dose of investigational medical product (IMP). An Independent Data Monitoring Committee (IDMC) will meet when the first 5 patients have reached 3 months follow up from their 1st dose of nivolumab or have withdrawn consent to follow-up. The IDMC, if satisfied with the safety data from the initial 5 patients, may recommend escalation to include recruitment of patients with ECOG performance status of 2.
Stereotactic body radiotherapy: Patients will receive a total of 54 Gy if delivered in 3 fractions, 55 Gy if delivered in 5 fractions or 60 Gy if delivered in 8 fractions.
Nivolumab: Nivolumab is a human immunoglobulin G4 (IgG4) monoclonal antibody, that binds to the PD-1 receptor and blocks interaction with its ligands PD-L1 and PD-L2. Nivolumab will be administered intravenously at a flat dose of 240 mg q2w over 30 minutes for 13 cycles followed by 480mg q4w over 60 minutes for 7 cycles, until 20 cycles in total to complete (a minimum of 1 year of treatment if no delays are encountered).
|
|---|---|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Dyspnea: Screening
|
22 score on a scale
Interval 0.0 to 56.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Dyspnea: 3 month PSBRT
|
22 score on a scale
Interval 0.0 to 89.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Dyspnea: 6 month PSBRT
|
22 score on a scale
Interval 0.0 to 100.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Dyspnea: 9 month PSBRT
|
33 score on a scale
Interval 0.0 to 67.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Dyspnea: 12 month PSBRT
|
33 score on a scale
Interval 0.0 to 89.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Dyspnea: 15 month PSBRT
|
22 score on a scale
Interval 0.0 to 89.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Dyspnea: 18 month PSBRT
|
33 score on a scale
Interval 0.0 to 67.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Coughing: 3 month PSBRT
|
33 score on a scale
Interval 0.0 to 100.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Coughing: 6 month PSBRT
|
33 score on a scale
Interval 0.0 to 100.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Coughing: 9 month PSBRT
|
33 score on a scale
Interval 0.0 to 100.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Coughing: 18 month PSBRT
|
33 score on a scale
Interval 0.0 to 100.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Coughing: 24 month PSBRT
|
0 score on a scale
Interval 0.0 to 100.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Haemoptysis: Screening
|
0 score on a scale
Interval 0.0 to 100.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Haemoptysis: 6 month PSBRT
|
0 score on a scale
Interval 0.0 to 33.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Haemoptysis: 9 month PSBRT
|
0 score on a scale
Interval 0.0 to 0.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Haemoptysis: 15 month PSBRT
|
0 score on a scale
Interval 0.0 to 0.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Haemoptysis: 18 month PSBRT
|
0 score on a scale
Interval 0.0 to 0.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Haemoptysis: 24 month PSBRT
|
0 score on a scale
Interval 0.0 to 33.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Sore mouth: Screening
|
0 score on a scale
Interval 0.0 to 33.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Sore mouth: 3 month PSBRT
|
0 score on a scale
Interval 0.0 to 100.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Sore mouth: 6 month PSBRT
|
0 score on a scale
Interval 0.0 to 100.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Sore mouth: 9 month PSBRT
|
0 score on a scale
Interval 0.0 to 67.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Sore mouth: 12 month PSBRT
|
0 score on a scale
Interval 0.0 to 67.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Sore mouth: 18 month PSBRT
|
0 score on a scale
Interval 0.0 to 100.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Sore mouth: 24 month PSBRT
|
0 score on a scale
Interval 0.0 to 67.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Dysphagia: Screening
|
0 score on a scale
Interval 0.0 to 33.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Dysphagia: 3 month PSBRT
|
0 score on a scale
Interval 0.0 to 67.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Dysphagia: 6 month PSBRT
|
0 score on a scale
Interval 0.0 to 100.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Dysphagia: 9 month PSBRT
|
0 score on a scale
Interval 0.0 to 67.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Dysphagia: 12 month PSBRT
|
0 score on a scale
Interval 0.0 to 67.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Dysphagia: 15 month PSBRT
|
0 score on a scale
Interval 0.0 to 67.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Dysphagia: 18 month PSBRT
|
0 score on a scale
Interval 0.0 to 33.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Dysphagia: 24 month PSBRT
|
0 score on a scale
Interval 0.0 to 67.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Peripheral neuropathy: Screening
|
0 score on a scale
Interval 0.0 to 67.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Peripheral neuropathy: 3 month PSBRT
|
0 score on a scale
Interval 0.0 to 67.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Peripheral neuropathy: 6 month PSBRT
|
0 score on a scale
Interval 0.0 to 100.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Peripheral neuropathy: 9 month PSBRT
|
0 score on a scale
Interval 0.0 to 67.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Peripheral neuropathy: 12 month PSBRT
|
0 score on a scale
Interval 0.0 to 67.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Peripheral neuropathy: 15 month PSBRT
|
17 score on a scale
Interval 0.0 to 67.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Peripheral neuropathy: 18 month PSBRT
|
0 score on a scale
Interval 0.0 to 67.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Peripheral neuropathy: 24 month PSBRT
|
0 score on a scale
Interval 0.0 to 67.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Alopecia: Screening
|
0 score on a scale
Interval 0.0 to 100.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Alopecia: 3 month PSBRT
|
0 score on a scale
Interval 0.0 to 67.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Alopecia: 6 month PSBRT
|
0 score on a scale
Interval 0.0 to 100.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Alopecia: 12 month PSBRT
|
0 score on a scale
Interval 0.0 to 67.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Alopecia: 15 month PSBRT
|
0 score on a scale
Interval 0.0 to 100.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Alopecia: 24 month PSBRT
|
0 score on a scale
Interval 0.0 to 100.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Pain in the chest: 3 month PSBRT
|
0 score on a scale
Interval 0.0 to 67.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Pain in the chest: 6 month PSBRT
|
0 score on a scale
Interval 0.0 to 100.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Pain in the chest: 9 month PSBRT
|
0 score on a scale
Interval 0.0 to 33.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Pain in the chest: 12 month PSBRT
|
0 score on a scale
Interval 0.0 to 100.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Pain in the chest: 15 month PSBRT
|
0 score on a scale
Interval 0.0 to 100.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Pain in the chest: 18 month PSBRT
|
0 score on a scale
Interval 0.0 to 67.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Pain in the chest: 24 month PSBRT
|
0 score on a scale
Interval 0.0 to 67.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Pain in the arm/shoulder: Screening
|
0 score on a scale
Interval 0.0 to 100.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Pain in the arm/shoulder: 3 month PSBRT
|
0 score on a scale
Interval 0.0 to 67.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Pain in the arm/shoulder: 6 month PSBRT
|
0 score on a scale
Interval 0.0 to 33.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Pain in the arm/shoulder: 15 month PSBRT
|
0 score on a scale
Interval 0.0 to 67.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Pain in the arm/shoulder: 18 month PSBRT
|
0 score on a scale
Interval 0.0 to 67.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Pain in the arm/shoulder: 24 month PSBRT
|
0 score on a scale
Interval 0.0 to 100.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Pain in other areas: Screening
|
0 score on a scale
Interval 0.0 to 100.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Pain in other areas: 9 month PSBRT
|
0 score on a scale
Interval 0.0 to 100.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Pain in other areas: 12 month PSBRT
|
33 score on a scale
Interval 0.0 to 100.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Pain in other areas: 24 month PSBRT
|
0 score on a scale
Interval 0.0 to 100.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Dyspnea: 24 month PSBRT
|
33 score on a scale
Interval 0.0 to 78.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Coughing: Screening
|
33 score on a scale
Interval 0.0 to 67.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Coughing: 12 month PSBRT
|
33 score on a scale
Interval 0.0 to 100.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Coughing: 15 month PSBRT
|
33 score on a scale
Interval 0.0 to 67.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Haemoptysis: 3 month PSBRT
|
0 score on a scale
Interval 0.0 to 33.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Haemoptysis: 12 month PSBRT
|
0 score on a scale
Interval 0.0 to 33.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Sore mouth: 15 month PSBRT
|
0 score on a scale
Interval 0.0 to 0.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Alopecia: 9 month PSBRT
|
0 score on a scale
Interval 0.0 to 67.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Alopecia: 18 month PSBRT
|
0 score on a scale
Interval 0.0 to 67.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Pain in the chest: Screening
|
0 score on a scale
Interval 0.0 to 67.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Pain in the arm/shoulder: 9 month PSBRT
|
0 score on a scale
Interval 0.0 to 100.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Pain in the arm/shoulder: 12 month PSBRT
|
0 score on a scale
Interval 0.0 to 100.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Pain in other areas: 3 month PSBRT
|
0 score on a scale
Interval 0.0 to 100.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Pain in other areas: 6 month PSBRT
|
0 score on a scale
Interval 0.0 to 100.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Pain in other areas: 15 month PSBRT
|
0 score on a scale
Interval 0.0 to 67.0
|
|
HRQoL Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) in Patients Treated With Nivolumab After SBRT for Early Stage NSCLC.
EORTC QLQ-LC13 Pain in other areas: 18 month PSBRT
|
0 score on a scale
Interval 0.0 to 100.0
|
Adverse Events
Arm 1 Tolerabilty
Serious events: 18 serious events
Other events: 30 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Arm 1 Tolerabilty
n=31 participants at risk
This is a single arm study of nivolumab administered on completion of stereotactic body radiotherapy (SBRT) to patients with early stage NSCLC. The first 5 patients to enroll must have Eastern Co-operative Oncology Group (ECOG) performance status \< 2 at the time of first dose of investigational medical product (IMP). An Independent Data Monitoring Committee (IDMC) will meet when the first 5 patients have reached 3 months follow up from their 1st dose of nivolumab or have withdrawn consent to follow-up. The IDMC, if satisfied with the safety data from the initial 5 patients, may recommend escalation to include recruitment of patients with ECOG performance status of 2.
Stereotactic body radiotherapy: Patients will receive a total of 54 Gy if delivered in 3 fractions, 55 Gy if delivered in 5 fractions or 60 Gy if delivered in 8 fractions.
Nivolumab: Nivolumab is a human immunoglobulin G4 (IgG4) monoclonal antibody, that binds to the PD-1 receptor and blocks interaction with its ligands PD-L1 and PD-L2. Nivolumab will be administered intravenously at a flat dose of 240 mg q2w over 30 minutes for 13 cycles followed by 480mg q4w over 60 minutes for 7 cycles, until 20 cycles in total to complete (a minimum of 1 year of treatment if no delays are encountered).
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Cardiac disorders
Chest pain
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Cardiac disorders
Heart failure
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Cardiac disorders
Myocardial infarction
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Endocrine disorders
Adrenal insufficiency
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Gastrointestinal disorders
Colitis
|
3.2%
1/31 • Number of events 3 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Gastrointestinal disorders
Diarrhea
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
General disorders
Infusion related reaction
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Infections and infestations
Bronchial infection
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Infections and infestations
Lung infection
|
12.9%
4/31 • Number of events 6 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Infections and infestations
Skin infection
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Infections and infestations
Urinary tract infection
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Nervous system disorders
Headache
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Nervous system disorders
Stroke
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Renal and urinary disorders
Urinary retention
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
9.7%
3/31 • Number of events 3 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Infections and infestations
Other
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Injury, poisoning and procedural complications
Other
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Musculoskeletal and connective tissue disorders
Other
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
Other adverse events
| Measure |
Arm 1 Tolerabilty
n=31 participants at risk
This is a single arm study of nivolumab administered on completion of stereotactic body radiotherapy (SBRT) to patients with early stage NSCLC. The first 5 patients to enroll must have Eastern Co-operative Oncology Group (ECOG) performance status \< 2 at the time of first dose of investigational medical product (IMP). An Independent Data Monitoring Committee (IDMC) will meet when the first 5 patients have reached 3 months follow up from their 1st dose of nivolumab or have withdrawn consent to follow-up. The IDMC, if satisfied with the safety data from the initial 5 patients, may recommend escalation to include recruitment of patients with ECOG performance status of 2.
Stereotactic body radiotherapy: Patients will receive a total of 54 Gy if delivered in 3 fractions, 55 Gy if delivered in 5 fractions or 60 Gy if delivered in 8 fractions.
Nivolumab: Nivolumab is a human immunoglobulin G4 (IgG4) monoclonal antibody, that binds to the PD-1 receptor and blocks interaction with its ligands PD-L1 and PD-L2. Nivolumab will be administered intravenously at a flat dose of 240 mg q2w over 30 minutes for 13 cycles followed by 480mg q4w over 60 minutes for 7 cycles, until 20 cycles in total to complete (a minimum of 1 year of treatment if no delays are encountered).
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
9.7%
3/31 • Number of events 3 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Cardiac disorders
Palpitations
|
3.2%
1/31 • Number of events 2 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Cardiac disorders
Sinus tachycardia
|
9.7%
3/31 • Number of events 3 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Endocrine disorders
Adrenal insufficiency
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Endocrine disorders
Hyperthyroidism
|
9.7%
3/31 • Number of events 4 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Endocrine disorders
Hypothyroidism
|
25.8%
8/31 • Number of events 8 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Eye disorders
Blurred vision
|
6.5%
2/31 • Number of events 2 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Eye disorders
Cataract
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Eye disorders
Dry eye
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Eye disorders
Floaters
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Eye disorders
Watering eyes
|
6.5%
2/31 • Number of events 2 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Gastrointestinal disorders
Colitis
|
3.2%
1/31 • Number of events 5 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Gastrointestinal disorders
Constipation
|
25.8%
8/31 • Number of events 9 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Gastrointestinal disorders
Diarrhea
|
25.8%
8/31 • Number of events 9 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Gastrointestinal disorders
Dry mouth
|
6.5%
2/31 • Number of events 2 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.5%
2/31 • Number of events 3 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Gastrointestinal disorders
Dysphagia
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Gastrointestinal disorders
Esophagitis
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Gastrointestinal disorders
Gastritis
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
6.5%
2/31 • Number of events 2 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Gastrointestinal disorders
Mucositis
|
9.7%
3/31 • Number of events 4 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Gastrointestinal disorders
Nausea
|
16.1%
5/31 • Number of events 6 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Gastrointestinal disorders
Obstruction gastic
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Gastrointestinal disorders
Oral dysesthesia
|
3.2%
1/31 • Number of events 3 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Gastrointestinal disorders
Vomiting
|
6.5%
2/31 • Number of events 2 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
General disorders
Edema face
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
General disorders
Edema limbs
|
9.7%
3/31 • Number of events 3 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
General disorders
Fatigue
|
51.6%
16/31 • Number of events 22 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
General disorders
Fever
|
6.5%
2/31 • Number of events 2 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
General disorders
Flu like symptoms
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
General disorders
Infusion related reaction
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Infections and infestations
Bronchial infection
|
6.5%
2/31 • Number of events 2 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Infections and infestations
Gum infection
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Infections and infestations
Lung infection
|
29.0%
9/31 • Number of events 14 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Infections and infestations
Lymph gland infection
|
3.2%
1/31 • Number of events 2 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Infections and infestations
Mucosal infection
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Infections and infestations
Sepsis
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Infections and infestations
Skin infection
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Infections and infestations
Upper Respiratory Infection
|
6.5%
2/31 • Number of events 2 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Infections and infestations
Urinary Tract Infection
|
6.5%
2/31 • Number of events 2 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Injury, poisoning and procedural complications
Bruising
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Injury, poisoning and procedural complications
Dermatitis Radiation
|
12.9%
4/31 • Number of events 4 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Injury, poisoning and procedural complications
Fall
|
6.5%
2/31 • Number of events 3 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Injury, poisoning and procedural complications
Venous injury
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Investigations
Alanine aminotransferase increased
|
12.9%
4/31 • Number of events 8 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Investigations
Alkaline phosphatase increased
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Investigations
Aspartate aminotransferase increased
|
12.9%
4/31 • Number of events 7 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Investigations
Blood bilirubin increased
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Investigations
CPK increased
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Investigations
Creatinine increased
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Investigations
GGT increased
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Investigations
Lipase increased
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Investigations
Serum amylase increased
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Investigations
Weight loss
|
6.5%
2/31 • Number of events 2 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Metabolism and nutrition disorders
Anorexia
|
19.4%
6/31 • Number of events 6 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Investigations
Hyperglycemia
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
6.5%
2/31 • Number of events 2 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
6.5%
2/31 • Number of events 3 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
9.7%
3/31 • Number of events 4 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
3.2%
1/31 • Number of events 2 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
19.4%
6/31 • Number of events 18 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.7%
3/31 • Number of events 3 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
9.7%
3/31 • Number of events 5 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
12.9%
4/31 • Number of events 4 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.5%
2/31 • Number of events 2 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Nervous system disorders
Ataxia
|
6.5%
2/31 • Number of events 2 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Nervous system disorders
Dizziness
|
12.9%
4/31 • Number of events 4 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Nervous system disorders
Dysarthria
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Nervous system disorders
Dysesthesia
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Nervous system disorders
Dysgeusia
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Nervous system disorders
Headache
|
22.6%
7/31 • Number of events 8 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Nervous system disorders
Memory impairment
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Nervous system disorders
Neuralgia
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
6.5%
2/31 • Number of events 2 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Pregnancy, puerperium and perinatal conditions
Peripheral sensory neuropathy
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Nervous system disorders
Seizure
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Nervous system disorders
Somnolence
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Psychiatric disorders
Anxiety
|
3.2%
1/31 • Number of events 2 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Psychiatric disorders
Confusion
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Psychiatric disorders
Depression
|
6.5%
2/31 • Number of events 2 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Psychiatric disorders
Insomnia
|
6.5%
2/31 • Number of events 2 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Renal and urinary disorders
Acute kidney injury
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Renal and urinary disorders
Hematuria
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Renal and urinary disorders
Urinary frequency
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
45.2%
14/31 • Number of events 21 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
25.8%
8/31 • Number of events 10 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
35.5%
11/31 • Number of events 19 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
6.5%
2/31 • Number of events 2 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
25.8%
8/31 • Number of events 8 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
6.5%
2/31 • Number of events 2 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
54.8%
17/31 • Number of events 21 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
12.9%
4/31 • Number of events 8 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
19.4%
6/31 • Number of events 7 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Vascular disorders
Hypertension
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Vascular disorders
Hypotension
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Blood and lymphatic system disorders
Other
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Cardiac disorders
Other
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Eye disorders
Other
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Gastrointestinal disorders
Other
|
9.7%
3/31 • Number of events 3 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
General disorders
Other
|
12.9%
4/31 • Number of events 4 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Infections and infestations
Other
|
16.1%
5/31 • Number of events 6 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Injury, poisoning and procedural complications
Other
|
6.5%
2/31 • Number of events 2 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Investigations
Other
|
9.7%
3/31 • Number of events 3 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Musculoskeletal and connective tissue disorders
Other
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Nervous system disorders
Other
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Renal and urinary disorders
Other
|
9.7%
3/31 • Number of events 3 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Respiratory, thoracic and mediastinal disorders
Other
|
16.1%
5/31 • Number of events 8 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Skin and subcutaneous tissue disorders
Other
|
25.8%
8/31 • Number of events 10 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Surgical and medical procedures
Other
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
|
Vascular disorders
Other
|
3.2%
1/31 • Number of events 1 • AEs will be recorded from consent until 100 days post the final infusion of nivolumab (average 12 cycles, typically 24 weeks, maximum 22 cycles/44 weeks). They will be systematically assessed at screening, each cycle of treatment (14 days), a safety follow-up visit (14 days after final infusion of nivolumab), and at each follow-up visit (3 month-, 6 month-, 9 month-, 12 month, 15 month-, 18 month- and 24 month-post SBRT) until participants reach the 100 days post the final infusion of nivolumab.
|
Additional Information
STILE Trial Manager
The Royal Marsden NHS Foundation Trust
Phone: +44 20 8915 6666
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place