Trial Outcomes & Findings for Durvalumab and Stereotactic Radiotherapy for Advanced NSCLC (NCT NCT04786093)
NCT ID: NCT04786093
Last Updated: 2026-05-05
Results Overview
To assess the impact of durvalumab and stereotactic radiotherapy, in the form of stereotactic ablative radiotherapy (SAbR) or personalized ultra-fractionated stereotactic adaptive radiotherapy (PULSAR), on improving QoL (quality of life) in patients with metastatic non-small cell lung cancer using the European organization for Research and treatment of cancer questionnaire (EORTC-QLQ30). The score range is 0-100. Higher the score, the better the results.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
1 participants
Primary outcome timeframe
2 years post-treatment
Results posted on
2026-05-05
Participant Flow
1 subject was enrolled on the PULSAR arm. No patients were enrolled on the SAbR while the study awaited sponsor modification until closure.
Participant milestones
| Measure |
Stereotactic Ablative Radiotherapy (SAbR) Arm Plus Durvalumab Arm
SAbR with each radiation treatment fraction delivered every other day
Stereotactic radiation therapy: Radiation therapy will be delivered using standard SAbR treatment schedule or every 4 weeks on the PULSAR schedule to achieve optimal local control of metastatic cancer and augment the effects of durvalumab.
Durvalumab: Durvalumab (initially developed as MEDI4736) is a human monoclonal antibody of the immunoglobulin (Ig) G1 kappa subclass that inhibits binding of PD-L1 (B7-H1, CD274) to PD-1 (CD279) and CD80 (B7-1). MEDI4736 is composed of 2 identical heavy chains and 2 identical light chains, with an overall molecular weight of approximately 149 kDa. MEDI4736 contains a triple mutation in the constant domain of the Ig G1 heavy chain that reduces binding to complement protein C1q and the fragment crystallizable gamma receptors involved in triggering effector function.
|
Personalized Ultra-fractionated Stereotactic Radiotherapy (PULSAR) Plus Durvalumab Arm
PULSAR with each radiation treatment fraction delivered every 4 weeks
Stereotactic radiation therapy: Radiation therapy will be delivered using standard SAbR treatment schedule or every 4 weeks on the PULSAR schedule to achieve optimal local control of metastatic cancer and augment the effects of durvalumab.
Durvalumab: Durvalumab (initially developed as MEDI4736) is a human monoclonal antibody of the immunoglobulin (Ig) G1 kappa subclass that inhibits binding of PD-L1 (B7-H1, CD274) to PD-1 (CD279) and CD80 (B7-1). MEDI4736 is composed of 2 identical heavy chains and 2 identical light chains, with an overall molecular weight of approximately 149 kDa. MEDI4736 contains a triple mutation in the constant domain of the Ig G1 heavy chain that reduces binding to complement protein C1q and the fragment crystallizable gamma receptors involved in triggering effector function.
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|---|---|---|
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Overall Study
STARTED
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0
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1
|
|
Overall Study
COMPLETED
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0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Durvalumab and Stereotactic Radiotherapy for Advanced NSCLC
Baseline characteristics by cohort
| Measure |
Stereotactic Ablative Radiotherapy (SAbR) Arm Plus Durvalumab Arm
SAbR with each radiation treatment fraction delivered every other day
Stereotactic radiation therapy: Radiation therapy will be delivered using standard SAbR treatment schedule or every 4 weeks on the PULSAR schedule to achieve optimal local control of metastatic cancer and augment the effects of durvalumab.
Durvalumab: Durvalumab (initially developed as MEDI4736) is a human monoclonal antibody of the immunoglobulin (Ig) G1 kappa subclass that inhibits binding of PD-L1 (B7-H1, CD274) to PD-1 (CD279) and CD80 (B7-1). MEDI4736 is composed of 2 identical heavy chains and 2 identical light chains, with an overall molecular weight of approximately 149 kDa. MEDI4736 contains a triple mutation in the constant domain of the Ig G1 heavy chain that reduces binding to complement protein C1q and the fragment crystallizable gamma receptors involved in triggering effector function.
|
Personalized Ultra-fractionated Stereotactic Radiotherapy (PULSAR) Plus Durvalumab Arm
n=1 Participants
PULSAR with each radiation treatment fraction delivered every 4 weeks
Stereotactic radiation therapy: Radiation therapy will be delivered using standard SAbR treatment schedule or every 4 weeks on the PULSAR schedule to achieve optimal local control of metastatic cancer and augment the effects of durvalumab.
Durvalumab: Durvalumab (initially developed as MEDI4736) is a human monoclonal antibody of the immunoglobulin (Ig) G1 kappa subclass that inhibits binding of PD-L1 (B7-H1, CD274) to PD-1 (CD279) and CD80 (B7-1). MEDI4736 is composed of 2 identical heavy chains and 2 identical light chains, with an overall molecular weight of approximately 149 kDa. MEDI4736 contains a triple mutation in the constant domain of the Ig G1 heavy chain that reduces binding to complement protein C1q and the fragment crystallizable gamma receptors involved in triggering effector function.
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Total
n=1 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Categorical
<=18 years
|
—
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
—
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Age, Categorical
>=65 years
|
—
|
1 Participants
n=60 Participants
|
1 Participants
n=114 Participants
|
|
Age, Continuous
|
—
|
67 years
n=60 Participants
|
67 years
n=114 Participants
|
|
Sex: Female, Male
Female
|
—
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Sex: Female, Male
Male
|
—
|
1 Participants
n=60 Participants
|
1 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
—
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
—
|
1 Participants
n=60 Participants
|
1 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
—
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
—
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Asian
|
—
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
—
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Black or African American
|
—
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
White
|
—
|
1 Participants
n=60 Participants
|
1 Participants
n=114 Participants
|
|
Race (NIH/OMB)
More than one race
|
—
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
—
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Region of Enrollment
United States
|
—
|
1 participants
n=60 Participants
|
1 participants
n=114 Participants
|
PRIMARY outcome
Timeframe: 2 years post-treatmentPopulation: 1 subject was enrolled on the PULSAR arm but terminated treatment early and data was not collected necessary to evaluate this measure.
To assess the impact of durvalumab and stereotactic radiotherapy, in the form of stereotactic ablative radiotherapy (SAbR) or personalized ultra-fractionated stereotactic adaptive radiotherapy (PULSAR), on improving QoL (quality of life) in patients with metastatic non-small cell lung cancer using the European organization for Research and treatment of cancer questionnaire (EORTC-QLQ30). The score range is 0-100. Higher the score, the better the results.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 months post-treatmentPopulation: 1 participant was enrolled on the PULSAR arm of the study and was assessed until their withdrawal from the study, approximately 3 months after treatment completion and totaling 6 months since enrollment. No participants were enrolled on the SAbR while under an enrollment hold until the study was closed by the sponsor.
To determine the effect of PULSAR or SAbR plus durvalumab on local control. Local control is defined as the percentage of tumors without tumor failure within the irradiated field, as defined as growth on diagnostic imaging studies or evidence of viable cancer cells. Probability will be assessed using the Kaplan-Meier method.
Outcome measures
| Measure |
Stereotactic Ablative Radiotherapy (SAbR) Arm Plus Durvalumab Arm
SAbR with each radiation treatment fraction delivered every other day
Stereotactic radiation therapy: Radiation therapy will be delivered using standard SAbR treatment schedule or every 4 weeks on the PULSAR schedule to achieve optimal local control of metastatic cancer and augment the effects of durvalumab.
Durvalumab: Durvalumab (initially developed as MEDI4736) is a human monoclonal antibody of the immunoglobulin (Ig) G1 kappa subclass that inhibits binding of PD-L1 (B7-H1, CD274) to PD-1 (CD279) and CD80 (B7-1). MEDI4736 is composed of 2 identical heavy chains and 2 identical light chains, with an overall molecular weight of approximately 149 kDa. MEDI4736 contains a triple mutation in the constant domain of the Ig G1 heavy chain that reduces binding to complement protein C1q and the fragment crystallizable gamma receptors involved in triggering effector function.
|
Personalized Ultra-fractionated Stereotactic Radiotherapy (PULSAR) Plus Durvalumab Arm
n=1 Participants
PULSAR with each radiation treatment fraction delivered every 4 weeks
Stereotactic radiation therapy: Radiation therapy will be delivered using standard SAbR treatment schedule or every 4 weeks on the PULSAR schedule to achieve optimal local control of metastatic cancer and augment the effects of durvalumab.
Durvalumab: Durvalumab (initially developed as MEDI4736) is a human monoclonal antibody of the immunoglobulin (Ig) G1 kappa subclass that inhibits binding of PD-L1 (B7-H1, CD274) to PD-1 (CD279) and CD80 (B7-1). MEDI4736 is composed of 2 identical heavy chains and 2 identical light chains, with an overall molecular weight of approximately 149 kDa. MEDI4736 contains a triple mutation in the constant domain of the Ig G1 heavy chain that reduces binding to complement protein C1q and the fragment crystallizable gamma receptors involved in triggering effector function.
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|---|---|---|
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Local Control (LC)
|
—
|
0 percentage of tumors
|
SECONDARY outcome
Timeframe: 3-months post-treatmentPopulation: 1 participant was enrolled on the PULSAR arm of the study. No patients were enrolled on the SAbR arm of the study while under an enrollment hold until the study was closed by the sponsor.
To assess the effect of PULSAR or SAbR plus durvalumab on out-of-field control (termed abscopal response). Out-of-field control is defined as the percentage of tumors without tumor failure outside of the irradiated field, as defined as growth on diagnostic imaging studies or evidence of viable cancer cells. Probability will be assessed using the Kaplan-Meier method.
Outcome measures
| Measure |
Stereotactic Ablative Radiotherapy (SAbR) Arm Plus Durvalumab Arm
SAbR with each radiation treatment fraction delivered every other day
Stereotactic radiation therapy: Radiation therapy will be delivered using standard SAbR treatment schedule or every 4 weeks on the PULSAR schedule to achieve optimal local control of metastatic cancer and augment the effects of durvalumab.
Durvalumab: Durvalumab (initially developed as MEDI4736) is a human monoclonal antibody of the immunoglobulin (Ig) G1 kappa subclass that inhibits binding of PD-L1 (B7-H1, CD274) to PD-1 (CD279) and CD80 (B7-1). MEDI4736 is composed of 2 identical heavy chains and 2 identical light chains, with an overall molecular weight of approximately 149 kDa. MEDI4736 contains a triple mutation in the constant domain of the Ig G1 heavy chain that reduces binding to complement protein C1q and the fragment crystallizable gamma receptors involved in triggering effector function.
|
Personalized Ultra-fractionated Stereotactic Radiotherapy (PULSAR) Plus Durvalumab Arm
n=1 Participants
PULSAR with each radiation treatment fraction delivered every 4 weeks
Stereotactic radiation therapy: Radiation therapy will be delivered using standard SAbR treatment schedule or every 4 weeks on the PULSAR schedule to achieve optimal local control of metastatic cancer and augment the effects of durvalumab.
Durvalumab: Durvalumab (initially developed as MEDI4736) is a human monoclonal antibody of the immunoglobulin (Ig) G1 kappa subclass that inhibits binding of PD-L1 (B7-H1, CD274) to PD-1 (CD279) and CD80 (B7-1). MEDI4736 is composed of 2 identical heavy chains and 2 identical light chains, with an overall molecular weight of approximately 149 kDa. MEDI4736 contains a triple mutation in the constant domain of the Ig G1 heavy chain that reduces binding to complement protein C1q and the fragment crystallizable gamma receptors involved in triggering effector function.
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|---|---|---|
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Out-of-field Control
|
—
|
0 percentage of tumors
|
SECONDARY outcome
Timeframe: 3 months post-treatmentPopulation: 1 participant was assessed on the PULSAR arm. No participants were enrolled in the SAbR arm while enrollment was held until sponsor closure.
To determine the effect of PULSAR or SAbR plus durvalumab on progression-free survival. Progression-free survival (PFS) is defined as the time from random assignment to disease progression or death from any cause. Probability will be assessed using the Kaplan-Meier method.
Outcome measures
| Measure |
Stereotactic Ablative Radiotherapy (SAbR) Arm Plus Durvalumab Arm
SAbR with each radiation treatment fraction delivered every other day
Stereotactic radiation therapy: Radiation therapy will be delivered using standard SAbR treatment schedule or every 4 weeks on the PULSAR schedule to achieve optimal local control of metastatic cancer and augment the effects of durvalumab.
Durvalumab: Durvalumab (initially developed as MEDI4736) is a human monoclonal antibody of the immunoglobulin (Ig) G1 kappa subclass that inhibits binding of PD-L1 (B7-H1, CD274) to PD-1 (CD279) and CD80 (B7-1). MEDI4736 is composed of 2 identical heavy chains and 2 identical light chains, with an overall molecular weight of approximately 149 kDa. MEDI4736 contains a triple mutation in the constant domain of the Ig G1 heavy chain that reduces binding to complement protein C1q and the fragment crystallizable gamma receptors involved in triggering effector function.
|
Personalized Ultra-fractionated Stereotactic Radiotherapy (PULSAR) Plus Durvalumab Arm
n=1 Participants
PULSAR with each radiation treatment fraction delivered every 4 weeks
Stereotactic radiation therapy: Radiation therapy will be delivered using standard SAbR treatment schedule or every 4 weeks on the PULSAR schedule to achieve optimal local control of metastatic cancer and augment the effects of durvalumab.
Durvalumab: Durvalumab (initially developed as MEDI4736) is a human monoclonal antibody of the immunoglobulin (Ig) G1 kappa subclass that inhibits binding of PD-L1 (B7-H1, CD274) to PD-1 (CD279) and CD80 (B7-1). MEDI4736 is composed of 2 identical heavy chains and 2 identical light chains, with an overall molecular weight of approximately 149 kDa. MEDI4736 contains a triple mutation in the constant domain of the Ig G1 heavy chain that reduces binding to complement protein C1q and the fragment crystallizable gamma receptors involved in triggering effector function.
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|---|---|---|
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Progression Free Survival (PFS)
|
—
|
0.23 years
Interval 0.23 to 0.23
|
SECONDARY outcome
Timeframe: 3 months post-treatmentPopulation: 1 participant was enrolled in the PULSAR arm. No participants were enrolled in the SAbR while the study was in an enrollment hold until study closure by the sponsor.
To determine the effect of PULSAR or SAbR plus durvalumab on overall survival. Overall survival (OS) is defined as the defined as the time between the date of randomization and the date of death due to any cause. Probability will be assessed using the Kaplan-Meier method.
Outcome measures
| Measure |
Stereotactic Ablative Radiotherapy (SAbR) Arm Plus Durvalumab Arm
SAbR with each radiation treatment fraction delivered every other day
Stereotactic radiation therapy: Radiation therapy will be delivered using standard SAbR treatment schedule or every 4 weeks on the PULSAR schedule to achieve optimal local control of metastatic cancer and augment the effects of durvalumab.
Durvalumab: Durvalumab (initially developed as MEDI4736) is a human monoclonal antibody of the immunoglobulin (Ig) G1 kappa subclass that inhibits binding of PD-L1 (B7-H1, CD274) to PD-1 (CD279) and CD80 (B7-1). MEDI4736 is composed of 2 identical heavy chains and 2 identical light chains, with an overall molecular weight of approximately 149 kDa. MEDI4736 contains a triple mutation in the constant domain of the Ig G1 heavy chain that reduces binding to complement protein C1q and the fragment crystallizable gamma receptors involved in triggering effector function.
|
Personalized Ultra-fractionated Stereotactic Radiotherapy (PULSAR) Plus Durvalumab Arm
n=1 Participants
PULSAR with each radiation treatment fraction delivered every 4 weeks
Stereotactic radiation therapy: Radiation therapy will be delivered using standard SAbR treatment schedule or every 4 weeks on the PULSAR schedule to achieve optimal local control of metastatic cancer and augment the effects of durvalumab.
Durvalumab: Durvalumab (initially developed as MEDI4736) is a human monoclonal antibody of the immunoglobulin (Ig) G1 kappa subclass that inhibits binding of PD-L1 (B7-H1, CD274) to PD-1 (CD279) and CD80 (B7-1). MEDI4736 is composed of 2 identical heavy chains and 2 identical light chains, with an overall molecular weight of approximately 149 kDa. MEDI4736 contains a triple mutation in the constant domain of the Ig G1 heavy chain that reduces binding to complement protein C1q and the fragment crystallizable gamma receptors involved in triggering effector function.
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|---|---|---|
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Overall Survival
|
—
|
0.41 years
Interval 0.41 to 0.41
|
SECONDARY outcome
Timeframe: 12 weeks from randomizationPopulation: 1 participant was enrolled on the PULSAR arm of the study but did not meet the 12 week timepoint, and data was not collected necessary to evaluate this measure.
To determine the effect of PULSAR or SAbR plus durvalumab on overall response rate at 12 weeks. Overall response rate is defined as complete response and partial response at 12 weeks (about 3 months) from randomization.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 months post-treatmentPopulation: 1 participant was enrolled in the PULSAR arm. No participants were enrolled in the SAbR while under an enrollment hold until the study was closed by the sponsor.
To determine the effect of PULSAR or SAbR plus durvalumab on toxicity. Toxicity will be assessed using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). Only adverse events assessed to be definitely, probably, or possibly related to protocol treatment will be considered.
Outcome measures
| Measure |
Stereotactic Ablative Radiotherapy (SAbR) Arm Plus Durvalumab Arm
SAbR with each radiation treatment fraction delivered every other day
Stereotactic radiation therapy: Radiation therapy will be delivered using standard SAbR treatment schedule or every 4 weeks on the PULSAR schedule to achieve optimal local control of metastatic cancer and augment the effects of durvalumab.
Durvalumab: Durvalumab (initially developed as MEDI4736) is a human monoclonal antibody of the immunoglobulin (Ig) G1 kappa subclass that inhibits binding of PD-L1 (B7-H1, CD274) to PD-1 (CD279) and CD80 (B7-1). MEDI4736 is composed of 2 identical heavy chains and 2 identical light chains, with an overall molecular weight of approximately 149 kDa. MEDI4736 contains a triple mutation in the constant domain of the Ig G1 heavy chain that reduces binding to complement protein C1q and the fragment crystallizable gamma receptors involved in triggering effector function.
|
Personalized Ultra-fractionated Stereotactic Radiotherapy (PULSAR) Plus Durvalumab Arm
n=1 Participants
PULSAR with each radiation treatment fraction delivered every 4 weeks
Stereotactic radiation therapy: Radiation therapy will be delivered using standard SAbR treatment schedule or every 4 weeks on the PULSAR schedule to achieve optimal local control of metastatic cancer and augment the effects of durvalumab.
Durvalumab: Durvalumab (initially developed as MEDI4736) is a human monoclonal antibody of the immunoglobulin (Ig) G1 kappa subclass that inhibits binding of PD-L1 (B7-H1, CD274) to PD-1 (CD279) and CD80 (B7-1). MEDI4736 is composed of 2 identical heavy chains and 2 identical light chains, with an overall molecular weight of approximately 149 kDa. MEDI4736 contains a triple mutation in the constant domain of the Ig G1 heavy chain that reduces binding to complement protein C1q and the fragment crystallizable gamma receptors involved in triggering effector function.
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|---|---|---|
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Instances of Toxicity
|
—
|
1 events
|
Adverse Events
Stereotactic Ablative Radiotherapy (SAbR) Arm Plus Durvalumab Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Personalized Ultra-fractionated Stereotactic Radiotherapy (PULSAR) Plus Durvalumab Arm
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Stereotactic Ablative Radiotherapy (SAbR) Arm Plus Durvalumab Arm
SAbR with each radiation treatment fraction delivered every other day
Stereotactic radiation therapy: Radiation therapy will be delivered using standard SAbR treatment schedule or every 4 weeks on the PULSAR schedule to achieve optimal local control of metastatic cancer and augment the effects of durvalumab.
Durvalumab: Durvalumab (initially developed as MEDI4736) is a human monoclonal antibody of the immunoglobulin (Ig) G1 kappa subclass that inhibits binding of PD-L1 (B7-H1, CD274) to PD-1 (CD279) and CD80 (B7-1). MEDI4736 is composed of 2 identical heavy chains and 2 identical light chains, with an overall molecular weight of approximately 149 kDa. MEDI4736 contains a triple mutation in the constant domain of the Ig G1 heavy chain that reduces binding to complement protein C1q and the fragment crystallizable gamma receptors involved in triggering effector function.
|
Personalized Ultra-fractionated Stereotactic Radiotherapy (PULSAR) Plus Durvalumab Arm
n=1 participants at risk
PULSAR with each radiation treatment fraction delivered every 4 weeks
Stereotactic radiation therapy: Radiation therapy will be delivered using standard SAbR treatment schedule or every 4 weeks on the PULSAR schedule to achieve optimal local control of metastatic cancer and augment the effects of durvalumab.
Durvalumab: Durvalumab (initially developed as MEDI4736) is a human monoclonal antibody of the immunoglobulin (Ig) G1 kappa subclass that inhibits binding of PD-L1 (B7-H1, CD274) to PD-1 (CD279) and CD80 (B7-1). MEDI4736 is composed of 2 identical heavy chains and 2 identical light chains, with an overall molecular weight of approximately 149 kDa. MEDI4736 contains a triple mutation in the constant domain of the Ig G1 heavy chain that reduces binding to complement protein C1q and the fragment crystallizable gamma receptors involved in triggering effector function.
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|---|---|---|
|
Infections and infestations
Lung infection
|
—
0/0 • Adverse were collected for the one participant enrolled from the time period of signing informed consent through approximately 3 months post-treatment, totaling approximately 6 months considering a treatment period of about 3 months.
1 participant was enrolled in the PULSAR arm of the study. No participants were enrolled in the SAbR arm of the study while under an enrollment hold until the sponsor closed the study. Therefore, there were no SAbR arm participants at risk for Serious Adverse Events or All-Cause Mortality.
|
100.0%
1/1 • Number of events 1 • Adverse were collected for the one participant enrolled from the time period of signing informed consent through approximately 3 months post-treatment, totaling approximately 6 months considering a treatment period of about 3 months.
1 participant was enrolled in the PULSAR arm of the study. No participants were enrolled in the SAbR arm of the study while under an enrollment hold until the sponsor closed the study. Therefore, there were no SAbR arm participants at risk for Serious Adverse Events or All-Cause Mortality.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
—
0/0 • Adverse were collected for the one participant enrolled from the time period of signing informed consent through approximately 3 months post-treatment, totaling approximately 6 months considering a treatment period of about 3 months.
1 participant was enrolled in the PULSAR arm of the study. No participants were enrolled in the SAbR arm of the study while under an enrollment hold until the sponsor closed the study. Therefore, there were no SAbR arm participants at risk for Serious Adverse Events or All-Cause Mortality.
|
100.0%
1/1 • Number of events 1 • Adverse were collected for the one participant enrolled from the time period of signing informed consent through approximately 3 months post-treatment, totaling approximately 6 months considering a treatment period of about 3 months.
1 participant was enrolled in the PULSAR arm of the study. No participants were enrolled in the SAbR arm of the study while under an enrollment hold until the sponsor closed the study. Therefore, there were no SAbR arm participants at risk for Serious Adverse Events or All-Cause Mortality.
|
Other adverse events
| Measure |
Stereotactic Ablative Radiotherapy (SAbR) Arm Plus Durvalumab Arm
SAbR with each radiation treatment fraction delivered every other day
Stereotactic radiation therapy: Radiation therapy will be delivered using standard SAbR treatment schedule or every 4 weeks on the PULSAR schedule to achieve optimal local control of metastatic cancer and augment the effects of durvalumab.
Durvalumab: Durvalumab (initially developed as MEDI4736) is a human monoclonal antibody of the immunoglobulin (Ig) G1 kappa subclass that inhibits binding of PD-L1 (B7-H1, CD274) to PD-1 (CD279) and CD80 (B7-1). MEDI4736 is composed of 2 identical heavy chains and 2 identical light chains, with an overall molecular weight of approximately 149 kDa. MEDI4736 contains a triple mutation in the constant domain of the Ig G1 heavy chain that reduces binding to complement protein C1q and the fragment crystallizable gamma receptors involved in triggering effector function.
|
Personalized Ultra-fractionated Stereotactic Radiotherapy (PULSAR) Plus Durvalumab Arm
n=1 participants at risk
PULSAR with each radiation treatment fraction delivered every 4 weeks
Stereotactic radiation therapy: Radiation therapy will be delivered using standard SAbR treatment schedule or every 4 weeks on the PULSAR schedule to achieve optimal local control of metastatic cancer and augment the effects of durvalumab.
Durvalumab: Durvalumab (initially developed as MEDI4736) is a human monoclonal antibody of the immunoglobulin (Ig) G1 kappa subclass that inhibits binding of PD-L1 (B7-H1, CD274) to PD-1 (CD279) and CD80 (B7-1). MEDI4736 is composed of 2 identical heavy chains and 2 identical light chains, with an overall molecular weight of approximately 149 kDa. MEDI4736 contains a triple mutation in the constant domain of the Ig G1 heavy chain that reduces binding to complement protein C1q and the fragment crystallizable gamma receptors involved in triggering effector function.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
—
0/0 • Adverse were collected for the one participant enrolled from the time period of signing informed consent through approximately 3 months post-treatment, totaling approximately 6 months considering a treatment period of about 3 months.
1 participant was enrolled in the PULSAR arm of the study. No participants were enrolled in the SAbR arm of the study while under an enrollment hold until the sponsor closed the study. Therefore, there were no SAbR arm participants at risk for Serious Adverse Events or All-Cause Mortality.
|
100.0%
1/1 • Number of events 1 • Adverse were collected for the one participant enrolled from the time period of signing informed consent through approximately 3 months post-treatment, totaling approximately 6 months considering a treatment period of about 3 months.
1 participant was enrolled in the PULSAR arm of the study. No participants were enrolled in the SAbR arm of the study while under an enrollment hold until the sponsor closed the study. Therefore, there were no SAbR arm participants at risk for Serious Adverse Events or All-Cause Mortality.
|
|
Metabolism and nutrition disorders
Anorexia
|
—
0/0 • Adverse were collected for the one participant enrolled from the time period of signing informed consent through approximately 3 months post-treatment, totaling approximately 6 months considering a treatment period of about 3 months.
1 participant was enrolled in the PULSAR arm of the study. No participants were enrolled in the SAbR arm of the study while under an enrollment hold until the sponsor closed the study. Therefore, there were no SAbR arm participants at risk for Serious Adverse Events or All-Cause Mortality.
|
100.0%
1/1 • Number of events 1 • Adverse were collected for the one participant enrolled from the time period of signing informed consent through approximately 3 months post-treatment, totaling approximately 6 months considering a treatment period of about 3 months.
1 participant was enrolled in the PULSAR arm of the study. No participants were enrolled in the SAbR arm of the study while under an enrollment hold until the sponsor closed the study. Therefore, there were no SAbR arm participants at risk for Serious Adverse Events or All-Cause Mortality.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
—
0/0 • Adverse were collected for the one participant enrolled from the time period of signing informed consent through approximately 3 months post-treatment, totaling approximately 6 months considering a treatment period of about 3 months.
1 participant was enrolled in the PULSAR arm of the study. No participants were enrolled in the SAbR arm of the study while under an enrollment hold until the sponsor closed the study. Therefore, there were no SAbR arm participants at risk for Serious Adverse Events or All-Cause Mortality.
|
100.0%
1/1 • Number of events 1 • Adverse were collected for the one participant enrolled from the time period of signing informed consent through approximately 3 months post-treatment, totaling approximately 6 months considering a treatment period of about 3 months.
1 participant was enrolled in the PULSAR arm of the study. No participants were enrolled in the SAbR arm of the study while under an enrollment hold until the sponsor closed the study. Therefore, there were no SAbR arm participants at risk for Serious Adverse Events or All-Cause Mortality.
|
|
Infections and infestations
Infections and infestations - COVID-19
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—
0/0 • Adverse were collected for the one participant enrolled from the time period of signing informed consent through approximately 3 months post-treatment, totaling approximately 6 months considering a treatment period of about 3 months.
1 participant was enrolled in the PULSAR arm of the study. No participants were enrolled in the SAbR arm of the study while under an enrollment hold until the sponsor closed the study. Therefore, there were no SAbR arm participants at risk for Serious Adverse Events or All-Cause Mortality.
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100.0%
1/1 • Number of events 1 • Adverse were collected for the one participant enrolled from the time period of signing informed consent through approximately 3 months post-treatment, totaling approximately 6 months considering a treatment period of about 3 months.
1 participant was enrolled in the PULSAR arm of the study. No participants were enrolled in the SAbR arm of the study while under an enrollment hold until the sponsor closed the study. Therefore, there were no SAbR arm participants at risk for Serious Adverse Events or All-Cause Mortality.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place