Trial Outcomes & Findings for Neoadjuvant Anti PD-1 Immunotherapy in Resectable Non-small Cell Lung Cancer (NCT NCT03197467)
NCT ID: NCT03197467
Last Updated: 2025-04-04
Results Overview
The definition for this endpoint was neoadjuvant pembrolizumab treatment followed by successful curative intent tumor resection.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
From screening until surgery, ca. 6-8 weeks
Results posted on
2025-04-04
Participant Flow
Participant milestones
| Measure |
Pembrolizumab
Pembrolizumab at fixed dose: 200 mg q3w i.v. for 2 cycles
Pembrolizumab: Pembrolizumab at fixed dose: 200 mg q3w i.v. for 2 cycles
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
29
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Pembrolizumab
Pembrolizumab at fixed dose: 200 mg q3w i.v. for 2 cycles
Pembrolizumab: Pembrolizumab at fixed dose: 200 mg q3w i.v. for 2 cycles
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Neoadjuvant Anti PD-1 Immunotherapy in Resectable Non-small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Pembrolizumab
n=29 Participants
Pembrolizumab at fixed dose: 200 mg q3w i.v. for 2 cycles
Pembrolizumab: Pembrolizumab at fixed dose: 200 mg q3w i.v. for 2 cycles
|
|---|---|
|
Age, Continuous
|
60 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
Germany
|
29 participants
n=99 Participants
|
|
ECOG status
ECOG 0
|
14 Participants
n=99 Participants
|
|
ECOG status
ECOG 1
|
15 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: From screening until surgery, ca. 6-8 weeksThe definition for this endpoint was neoadjuvant pembrolizumab treatment followed by successful curative intent tumor resection.
Outcome measures
| Measure |
Pembrolizumab
n=29 Participants
Pembrolizumab at fixed dose: 200 mg q3w i.v. for 2 cycles
Pembrolizumab: Pembrolizumab at fixed dose: 200 mg q3w i.v. for 2 cycles
|
|---|---|
|
Number of Patients Treated in Compliance With Protocol
|
29 Participants
|
PRIMARY outcome
Timeframe: From screening until pre-surgery radiologic assessment, ca. 6-8 weeksRadiologic tumor assessments were performed at screening and pre-surgery.
Outcome measures
| Measure |
Pembrolizumab
n=28 Participants
Pembrolizumab at fixed dose: 200 mg q3w i.v. for 2 cycles
Pembrolizumab: Pembrolizumab at fixed dose: 200 mg q3w i.v. for 2 cycles
|
|---|---|
|
Tumor Response According to RECIST 1.1 Criteria
Complete response
|
0 Participants
|
|
Tumor Response According to RECIST 1.1 Criteria
Partial response
|
6 Participants
|
|
Tumor Response According to RECIST 1.1 Criteria
Stable disease
|
19 Participants
|
|
Tumor Response According to RECIST 1.1 Criteria
Progressive disease
|
3 Participants
|
PRIMARY outcome
Timeframe: From screening until surgery, ca. 6-8 weeksPathologic regression grading according to Junker criteria. The following grades are defined: Grade I No tumor regression or only spontaneous tumor regression in the sections of the primary tumor and mediastinal lymph nodes. Grade IIa Morphological signs of therapy-induced tumor regression in the sections of the primary tumor and/or mediastinal lymph nodes: More than 10% vital tumor tissue Grade IIb Morphological signs of therapy-induced tumor regression: Less than 10% vital tumor tissue Grade III Complete tumor regression, no evidence of vital tumor in the sections of the primary tumor and/or mediastinal lymph nodes. Regression grades IIb and III suggest a good response to neoadjuvant therapy. Reference: Junker K, Langner K, Klinke F, Bosse U, Thomas M. Grading of tumor regression in non-small cell lung cancer : morphology and prognosis. Chest 2001; 120:1584-91.
Outcome measures
| Measure |
Pembrolizumab
n=29 Participants
Pembrolizumab at fixed dose: 200 mg q3w i.v. for 2 cycles
Pembrolizumab: Pembrolizumab at fixed dose: 200 mg q3w i.v. for 2 cycles
|
|---|---|
|
Tumor Response Evaluation - Pathologic Response
Grade I
|
4 Participants
|
|
Tumor Response Evaluation - Pathologic Response
Grade IIa
|
18 Participants
|
|
Tumor Response Evaluation - Pathologic Response
Grade IIb
|
3 Participants
|
|
Tumor Response Evaluation - Pathologic Response
Grade III
|
4 Participants
|
PRIMARY outcome
Timeframe: From screening until pre-surgery radiologic assessment, ca. 6-8 weeksΔ tumor size was defined as the difference \[mm\] between longest diameter at baseline and pre-surgery.
Outcome measures
| Measure |
Pembrolizumab
n=28 Participants
Pembrolizumab at fixed dose: 200 mg q3w i.v. for 2 cycles
Pembrolizumab: Pembrolizumab at fixed dose: 200 mg q3w i.v. for 2 cycles
|
|---|---|
|
Tumor Response Evaluation - Δ Tumor Size
|
-4.0 mm
Interval -13.5 to 0.0
|
PRIMARY outcome
Timeframe: From screening until pre-surgery radiologic assessment, ca. 6-8 weeksΔ PET activity (standardized uptake value \[SUV\]). This method uses radiolabeled tracer 82-deoxy-2-\[18F\]fluoro-D-glucose, FDG) during PET imaging of the tumor and accumulation of radiolabeled FDG measured by the PET scanner. Accumulation of FDG relative to normal tissue is related to the proliferative activity of malignant tissue and to the number of viable tumor cells. The endpoint is based on per-patient changes in tumor maximal standardized uptake value during PET examinations of the tumor before the start of treatment and after 2 cycles of neoadjuvant immunotherapy, i.e. between screening and shortly before surgery. Reduction of proliferative activity or of the number of viable tumor cells results in negative values.
Outcome measures
| Measure |
Pembrolizumab
n=28 Participants
Pembrolizumab at fixed dose: 200 mg q3w i.v. for 2 cycles
Pembrolizumab: Pembrolizumab at fixed dose: 200 mg q3w i.v. for 2 cycles
|
|---|---|
|
Tumor Response - Δ PET Activity
|
-1 standardized uptake value [SUV]
Interval -7.0 to 2.0
|
SECONDARY outcome
Timeframe: 6 months after surgery, i.e. circa 8 months after treatment startProbability of disease-free survival (DFS) was calculated using Kaplan-Meier statistics from date of surgery to the date until tumor recurrence or death. Follow-up was until 24 months after last-patient-out.
Outcome measures
| Measure |
Pembrolizumab
n=29 Participants
Pembrolizumab at fixed dose: 200 mg q3w i.v. for 2 cycles
Pembrolizumab: Pembrolizumab at fixed dose: 200 mg q3w i.v. for 2 cycles
|
|---|---|
|
Disease-free Survival at 6 Months
|
86.2 Probablity of DFS in %
Interval 67.3 to 94.6
|
SECONDARY outcome
Timeframe: 12 months after surgery, i.e. circa 14 months after treatment startProbability of disease-free survival (DFS) was calculated from date of surgery until tumor recurrence or death using Kaplan-Meier statistics. Follow-up was until 24 months after last-patient-out.
Outcome measures
| Measure |
Pembrolizumab
n=29 Participants
Pembrolizumab at fixed dose: 200 mg q3w i.v. for 2 cycles
Pembrolizumab: Pembrolizumab at fixed dose: 200 mg q3w i.v. for 2 cycles
|
|---|---|
|
Disease-free Survival at 12 Months
|
86.2 Probablity of DFS in %
Interval 67.3 to 94.6
|
SECONDARY outcome
Timeframe: 12 months after surgery, i.e. circa 14 months after treatment startProbability of overall survival (OS) was calculated from date of surgery until date of death using Kaplan-Meier statistics. Follow-up was until 24 months after last-patient-out.
Outcome measures
| Measure |
Pembrolizumab
n=29 Participants
Pembrolizumab at fixed dose: 200 mg q3w i.v. for 2 cycles
Pembrolizumab: Pembrolizumab at fixed dose: 200 mg q3w i.v. for 2 cycles
|
|---|---|
|
Overall Survival at 12 Months
|
93.1 Probability of OS in %
Interval 75.1 to 98.2
|
SECONDARY outcome
Timeframe: 18 months after surgery, i.e. circa 20 months after treatment startProbability of overall survival (OS) was calculated from date of surgery until date of death using Kaplan-Meier statistics. Follow-up was until 24 months after last-patient-out.
Outcome measures
| Measure |
Pembrolizumab
n=29 Participants
Pembrolizumab at fixed dose: 200 mg q3w i.v. for 2 cycles
Pembrolizumab: Pembrolizumab at fixed dose: 200 mg q3w i.v. for 2 cycles
|
|---|---|
|
Overall Survival at 18 Months
|
89.7 Probability of OS in %
Interval 71.3 to 96.5
|
SECONDARY outcome
Timeframe: 24 months after surgery, i.e. circa 26 months after treatment startProbability of overall survival (OS) was calculated from date of surgery until date of death using Kaplan-Meier statistics. Follow-up was until 24 months after last-patient-out.
Outcome measures
| Measure |
Pembrolizumab
n=29 Participants
Pembrolizumab at fixed dose: 200 mg q3w i.v. for 2 cycles
Pembrolizumab: Pembrolizumab at fixed dose: 200 mg q3w i.v. for 2 cycles
|
|---|---|
|
Overall Survival at 24 Months
|
86.2 Probability of OS in %
Interval 67.3 to 94.6
|
Adverse Events
Pembrolizumab
Serious events: 8 serious events
Other events: 21 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Pembrolizumab
n=29 participants at risk
Pembrolizumab at fixed dose: 200 mg q3w i.v. for 2 cycles
Pembrolizumab: Pembrolizumab at fixed dose: 200 mg q3w i.v. for 2 cycles
|
|---|---|
|
Endocrine disorders
Hyperthyroidism
|
3.4%
1/29 • Number of events 1 • Adverse events were recorded from signing of informed consent until 90 days after last dose of IMP (total: 20-22 weeks) or for 6 weeks after surgery (total: 12-14 weeks) if the subject initiated new anticancer therapy. Deaths were recorded for up to 26 months after treatment initiation.
Note that deaths were recorded for up to 26 months after treatment initiation, but only for the purpose of collecting data for the overall survival efficacy endpoint. Of the total of 5 recorded deaths, only 1 fell within the time frame for safety reporting, and therefore, only 1 adverse event with fatal outcome is recorded in the safety database. This was a case of Acute Hepatic Failure reported as related to study treatment.
|
|
Gastrointestinal disorders
Colitis
|
3.4%
1/29 • Number of events 1 • Adverse events were recorded from signing of informed consent until 90 days after last dose of IMP (total: 20-22 weeks) or for 6 weeks after surgery (total: 12-14 weeks) if the subject initiated new anticancer therapy. Deaths were recorded for up to 26 months after treatment initiation.
Note that deaths were recorded for up to 26 months after treatment initiation, but only for the purpose of collecting data for the overall survival efficacy endpoint. Of the total of 5 recorded deaths, only 1 fell within the time frame for safety reporting, and therefore, only 1 adverse event with fatal outcome is recorded in the safety database. This was a case of Acute Hepatic Failure reported as related to study treatment.
|
|
Gastrointestinal disorders
Gastritis
|
3.4%
1/29 • Number of events 1 • Adverse events were recorded from signing of informed consent until 90 days after last dose of IMP (total: 20-22 weeks) or for 6 weeks after surgery (total: 12-14 weeks) if the subject initiated new anticancer therapy. Deaths were recorded for up to 26 months after treatment initiation.
Note that deaths were recorded for up to 26 months after treatment initiation, but only for the purpose of collecting data for the overall survival efficacy endpoint. Of the total of 5 recorded deaths, only 1 fell within the time frame for safety reporting, and therefore, only 1 adverse event with fatal outcome is recorded in the safety database. This was a case of Acute Hepatic Failure reported as related to study treatment.
|
|
Hepatobiliary disorders
Acute hepatic failure
|
3.4%
1/29 • Number of events 1 • Adverse events were recorded from signing of informed consent until 90 days after last dose of IMP (total: 20-22 weeks) or for 6 weeks after surgery (total: 12-14 weeks) if the subject initiated new anticancer therapy. Deaths were recorded for up to 26 months after treatment initiation.
Note that deaths were recorded for up to 26 months after treatment initiation, but only for the purpose of collecting data for the overall survival efficacy endpoint. Of the total of 5 recorded deaths, only 1 fell within the time frame for safety reporting, and therefore, only 1 adverse event with fatal outcome is recorded in the safety database. This was a case of Acute Hepatic Failure reported as related to study treatment.
|
|
Infections and infestations
Herpes zoster
|
3.4%
1/29 • Number of events 1 • Adverse events were recorded from signing of informed consent until 90 days after last dose of IMP (total: 20-22 weeks) or for 6 weeks after surgery (total: 12-14 weeks) if the subject initiated new anticancer therapy. Deaths were recorded for up to 26 months after treatment initiation.
Note that deaths were recorded for up to 26 months after treatment initiation, but only for the purpose of collecting data for the overall survival efficacy endpoint. Of the total of 5 recorded deaths, only 1 fell within the time frame for safety reporting, and therefore, only 1 adverse event with fatal outcome is recorded in the safety database. This was a case of Acute Hepatic Failure reported as related to study treatment.
|
|
Infections and infestations
Pneumonia
|
6.9%
2/29 • Number of events 2 • Adverse events were recorded from signing of informed consent until 90 days after last dose of IMP (total: 20-22 weeks) or for 6 weeks after surgery (total: 12-14 weeks) if the subject initiated new anticancer therapy. Deaths were recorded for up to 26 months after treatment initiation.
Note that deaths were recorded for up to 26 months after treatment initiation, but only for the purpose of collecting data for the overall survival efficacy endpoint. Of the total of 5 recorded deaths, only 1 fell within the time frame for safety reporting, and therefore, only 1 adverse event with fatal outcome is recorded in the safety database. This was a case of Acute Hepatic Failure reported as related to study treatment.
|
|
Skin and subcutaneous tissue disorders
Lichen planus
|
3.4%
1/29 • Number of events 2 • Adverse events were recorded from signing of informed consent until 90 days after last dose of IMP (total: 20-22 weeks) or for 6 weeks after surgery (total: 12-14 weeks) if the subject initiated new anticancer therapy. Deaths were recorded for up to 26 months after treatment initiation.
Note that deaths were recorded for up to 26 months after treatment initiation, but only for the purpose of collecting data for the overall survival efficacy endpoint. Of the total of 5 recorded deaths, only 1 fell within the time frame for safety reporting, and therefore, only 1 adverse event with fatal outcome is recorded in the safety database. This was a case of Acute Hepatic Failure reported as related to study treatment.
|
|
Gastrointestinal disorders
Gastric ulcer
|
3.4%
1/29 • Number of events 1 • Adverse events were recorded from signing of informed consent until 90 days after last dose of IMP (total: 20-22 weeks) or for 6 weeks after surgery (total: 12-14 weeks) if the subject initiated new anticancer therapy. Deaths were recorded for up to 26 months after treatment initiation.
Note that deaths were recorded for up to 26 months after treatment initiation, but only for the purpose of collecting data for the overall survival efficacy endpoint. Of the total of 5 recorded deaths, only 1 fell within the time frame for safety reporting, and therefore, only 1 adverse event with fatal outcome is recorded in the safety database. This was a case of Acute Hepatic Failure reported as related to study treatment.
|
Other adverse events
| Measure |
Pembrolizumab
n=29 participants at risk
Pembrolizumab at fixed dose: 200 mg q3w i.v. for 2 cycles
Pembrolizumab: Pembrolizumab at fixed dose: 200 mg q3w i.v. for 2 cycles
|
|---|---|
|
Endocrine disorders
Autoimmune thyreoditis
|
6.9%
2/29 • Number of events 2 • Adverse events were recorded from signing of informed consent until 90 days after last dose of IMP (total: 20-22 weeks) or for 6 weeks after surgery (total: 12-14 weeks) if the subject initiated new anticancer therapy. Deaths were recorded for up to 26 months after treatment initiation.
Note that deaths were recorded for up to 26 months after treatment initiation, but only for the purpose of collecting data for the overall survival efficacy endpoint. Of the total of 5 recorded deaths, only 1 fell within the time frame for safety reporting, and therefore, only 1 adverse event with fatal outcome is recorded in the safety database. This was a case of Acute Hepatic Failure reported as related to study treatment.
|
|
Endocrine disorders
Hyperthyroidism
|
6.9%
2/29 • Number of events 3 • Adverse events were recorded from signing of informed consent until 90 days after last dose of IMP (total: 20-22 weeks) or for 6 weeks after surgery (total: 12-14 weeks) if the subject initiated new anticancer therapy. Deaths were recorded for up to 26 months after treatment initiation.
Note that deaths were recorded for up to 26 months after treatment initiation, but only for the purpose of collecting data for the overall survival efficacy endpoint. Of the total of 5 recorded deaths, only 1 fell within the time frame for safety reporting, and therefore, only 1 adverse event with fatal outcome is recorded in the safety database. This was a case of Acute Hepatic Failure reported as related to study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
10.3%
3/29 • Number of events 3 • Adverse events were recorded from signing of informed consent until 90 days after last dose of IMP (total: 20-22 weeks) or for 6 weeks after surgery (total: 12-14 weeks) if the subject initiated new anticancer therapy. Deaths were recorded for up to 26 months after treatment initiation.
Note that deaths were recorded for up to 26 months after treatment initiation, but only for the purpose of collecting data for the overall survival efficacy endpoint. Of the total of 5 recorded deaths, only 1 fell within the time frame for safety reporting, and therefore, only 1 adverse event with fatal outcome is recorded in the safety database. This was a case of Acute Hepatic Failure reported as related to study treatment.
|
|
Gastrointestinal disorders
Nausea
|
10.3%
3/29 • Number of events 3 • Adverse events were recorded from signing of informed consent until 90 days after last dose of IMP (total: 20-22 weeks) or for 6 weeks after surgery (total: 12-14 weeks) if the subject initiated new anticancer therapy. Deaths were recorded for up to 26 months after treatment initiation.
Note that deaths were recorded for up to 26 months after treatment initiation, but only for the purpose of collecting data for the overall survival efficacy endpoint. Of the total of 5 recorded deaths, only 1 fell within the time frame for safety reporting, and therefore, only 1 adverse event with fatal outcome is recorded in the safety database. This was a case of Acute Hepatic Failure reported as related to study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
6.9%
2/29 • Number of events 2 • Adverse events were recorded from signing of informed consent until 90 days after last dose of IMP (total: 20-22 weeks) or for 6 weeks after surgery (total: 12-14 weeks) if the subject initiated new anticancer therapy. Deaths were recorded for up to 26 months after treatment initiation.
Note that deaths were recorded for up to 26 months after treatment initiation, but only for the purpose of collecting data for the overall survival efficacy endpoint. Of the total of 5 recorded deaths, only 1 fell within the time frame for safety reporting, and therefore, only 1 adverse event with fatal outcome is recorded in the safety database. This was a case of Acute Hepatic Failure reported as related to study treatment.
|
|
General disorders
Fatigue
|
13.8%
4/29 • Number of events 4 • Adverse events were recorded from signing of informed consent until 90 days after last dose of IMP (total: 20-22 weeks) or for 6 weeks after surgery (total: 12-14 weeks) if the subject initiated new anticancer therapy. Deaths were recorded for up to 26 months after treatment initiation.
Note that deaths were recorded for up to 26 months after treatment initiation, but only for the purpose of collecting data for the overall survival efficacy endpoint. Of the total of 5 recorded deaths, only 1 fell within the time frame for safety reporting, and therefore, only 1 adverse event with fatal outcome is recorded in the safety database. This was a case of Acute Hepatic Failure reported as related to study treatment.
|
|
General disorders
Pain
|
6.9%
2/29 • Number of events 2 • Adverse events were recorded from signing of informed consent until 90 days after last dose of IMP (total: 20-22 weeks) or for 6 weeks after surgery (total: 12-14 weeks) if the subject initiated new anticancer therapy. Deaths were recorded for up to 26 months after treatment initiation.
Note that deaths were recorded for up to 26 months after treatment initiation, but only for the purpose of collecting data for the overall survival efficacy endpoint. Of the total of 5 recorded deaths, only 1 fell within the time frame for safety reporting, and therefore, only 1 adverse event with fatal outcome is recorded in the safety database. This was a case of Acute Hepatic Failure reported as related to study treatment.
|
|
Infections and infestations
Pneumonia
|
10.3%
3/29 • Number of events 3 • Adverse events were recorded from signing of informed consent until 90 days after last dose of IMP (total: 20-22 weeks) or for 6 weeks after surgery (total: 12-14 weeks) if the subject initiated new anticancer therapy. Deaths were recorded for up to 26 months after treatment initiation.
Note that deaths were recorded for up to 26 months after treatment initiation, but only for the purpose of collecting data for the overall survival efficacy endpoint. Of the total of 5 recorded deaths, only 1 fell within the time frame for safety reporting, and therefore, only 1 adverse event with fatal outcome is recorded in the safety database. This was a case of Acute Hepatic Failure reported as related to study treatment.
|
|
General disorders
Decreased appetite
|
6.9%
2/29 • Number of events 2 • Adverse events were recorded from signing of informed consent until 90 days after last dose of IMP (total: 20-22 weeks) or for 6 weeks after surgery (total: 12-14 weeks) if the subject initiated new anticancer therapy. Deaths were recorded for up to 26 months after treatment initiation.
Note that deaths were recorded for up to 26 months after treatment initiation, but only for the purpose of collecting data for the overall survival efficacy endpoint. Of the total of 5 recorded deaths, only 1 fell within the time frame for safety reporting, and therefore, only 1 adverse event with fatal outcome is recorded in the safety database. This was a case of Acute Hepatic Failure reported as related to study treatment.
|
|
Nervous system disorders
Dizziness
|
10.3%
3/29 • Number of events 3 • Adverse events were recorded from signing of informed consent until 90 days after last dose of IMP (total: 20-22 weeks) or for 6 weeks after surgery (total: 12-14 weeks) if the subject initiated new anticancer therapy. Deaths were recorded for up to 26 months after treatment initiation.
Note that deaths were recorded for up to 26 months after treatment initiation, but only for the purpose of collecting data for the overall survival efficacy endpoint. Of the total of 5 recorded deaths, only 1 fell within the time frame for safety reporting, and therefore, only 1 adverse event with fatal outcome is recorded in the safety database. This was a case of Acute Hepatic Failure reported as related to study treatment.
|
|
Nervous system disorders
Paraesthesia
|
6.9%
2/29 • Number of events 2 • Adverse events were recorded from signing of informed consent until 90 days after last dose of IMP (total: 20-22 weeks) or for 6 weeks after surgery (total: 12-14 weeks) if the subject initiated new anticancer therapy. Deaths were recorded for up to 26 months after treatment initiation.
Note that deaths were recorded for up to 26 months after treatment initiation, but only for the purpose of collecting data for the overall survival efficacy endpoint. Of the total of 5 recorded deaths, only 1 fell within the time frame for safety reporting, and therefore, only 1 adverse event with fatal outcome is recorded in the safety database. This was a case of Acute Hepatic Failure reported as related to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.2%
5/29 • Number of events 5 • Adverse events were recorded from signing of informed consent until 90 days after last dose of IMP (total: 20-22 weeks) or for 6 weeks after surgery (total: 12-14 weeks) if the subject initiated new anticancer therapy. Deaths were recorded for up to 26 months after treatment initiation.
Note that deaths were recorded for up to 26 months after treatment initiation, but only for the purpose of collecting data for the overall survival efficacy endpoint. Of the total of 5 recorded deaths, only 1 fell within the time frame for safety reporting, and therefore, only 1 adverse event with fatal outcome is recorded in the safety database. This was a case of Acute Hepatic Failure reported as related to study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place