Trial Outcomes & Findings for Pembrolizumab With and Without Radiotherapy for Non-Small Cell Lung Cancer (NCT NCT03217071)
NCT ID: NCT03217071
Last Updated: 2024-10-23
Results Overview
The primary endpoint for this study is the change in the mean number of infiltrating CD3+ T cells/ μm2 in the lung cancer tissue from before and after pembrolizumab +/- SRT by group, based on quantification using immunohistochemistry (IHC) and image analysis by group.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
Up to 1 year
Results posted on
2024-10-23
Participant Flow
Participant milestones
| Measure |
Pembrolizumab + Surgery
Patients will receive 200mg pembrolizumab on Day 1 of each 3 week cycle, for 2 cycles, prior to surgery. Pembrolizumab will be administered via IV infusion for 30 minutes. Surgery will occur no later than 6 weeks following the last dose of pembrolizumab.
|
Pembrolizumab + Radiation + Surgery
Patients will receive 200mg pembrolizumab on Day 1 of each 3 week cycle, for 2 cycles. Pembrolizumab will be administered via IV infusion for 30 minutes.Within the week (7 days +/- 3 days) following administration of the second cycle, a single 12 Gy dose of stereotactic radiation therapy (SRT) will be delivered to 50% of the primary tumor only. Definitive surgical resection will occur no later than 6 weeks following the last dose of pembrolizumab.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pembrolizumab With and Without Radiotherapy for Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Pembrolizumab + Surgery
n=6 Participants
Patients will receive 200mg pembrolizumab on Day 1 of each 3 week cycle, for 2 cycles, prior to surgery. Pembrolizumab will be administered via IV infusion for 30 minutes. Surgery will occur no later than 6 weeks following the last dose of pembrolizumab.
|
Pembrolizumab + Radiation + Surgery
n=6 Participants
Patients will receive 200mg pembrolizumab on Day 1 of each 3 week cycle, for 2 cycles. Pembrolizumab will be administered via IV infusion for 30 minutes.Within the week (7 days +/- 3 days) following administration of the second cycle, a single 12 Gy dose of stereotactic radiation therapy (SRT) will be delivered to 50% of the primary tumor only. Definitive surgical resection will occur no later than 6 weeks following the last dose of pembrolizumab.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
40-49 years old
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Customized
50-59 years old
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Customized
60-69 years old
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Customized
70-79 years old
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 1 yearThe primary endpoint for this study is the change in the mean number of infiltrating CD3+ T cells/ μm2 in the lung cancer tissue from before and after pembrolizumab +/- SRT by group, based on quantification using immunohistochemistry (IHC) and image analysis by group.
Outcome measures
| Measure |
Pembrolizumab + Surgery
n=5 Participants
Patients will receive 200mg pembrolizumab on Day 1 of each 3 week cycle, for 2 cycles, prior to surgery. Pembrolizumab will be administered via IV infusion for 30 minutes. Surgery will occur no later than 6 weeks following the last dose of pembrolizumab.
|
Pembrolizumab + Radiation + Surgery
n=4 Participants
Patients will receive 200mg pembrolizumab on Day 1 of each 3 week cycle, for 2 cycles. Pembrolizumab will be administered via IV infusion for 30 minutes.Within the week (7 days +/- 3 days) following administration of the second cycle, a single 12 Gy dose of stereotactic radiation therapy (SRT) will be delivered to 50% of the primary tumor only. Definitive surgical resection will occur no later than 6 weeks following the last dose of pembrolizumab.
|
|---|---|---|
|
Change in the Mean Number of Infiltrating Absolute Cluster of Differentiation 3 (CD3+) T Cells/ μm2
|
2976.00007 CD3+ T cells/ μm2
Interval 851.0 to 722704.0
|
3768.74373 CD3+ T cells/ μm2
Interval 198.0 to 879551.0
|
PRIMARY outcome
Timeframe: Up to 1 yearThe percentage of participants achieving a two-fold increase from baseline in CD3+ T cells/μm2 will be reported. The goal of achieving a two-fold increase in 40 percent (%) of the evaluable population is a reasonable one, as estimated from a previous study showing greater-than-three-fold increase in 57% of patients when CD3+ T cells/μm2 were measured in prostate cancer tissue treated with a cell- based cancer immunotherapy.
Outcome measures
| Measure |
Pembrolizumab + Surgery
n=5 Participants
Patients will receive 200mg pembrolizumab on Day 1 of each 3 week cycle, for 2 cycles, prior to surgery. Pembrolizumab will be administered via IV infusion for 30 minutes. Surgery will occur no later than 6 weeks following the last dose of pembrolizumab.
|
Pembrolizumab + Radiation + Surgery
n=4 Participants
Patients will receive 200mg pembrolizumab on Day 1 of each 3 week cycle, for 2 cycles. Pembrolizumab will be administered via IV infusion for 30 minutes.Within the week (7 days +/- 3 days) following administration of the second cycle, a single 12 Gy dose of stereotactic radiation therapy (SRT) will be delivered to 50% of the primary tumor only. Definitive surgical resection will occur no later than 6 weeks following the last dose of pembrolizumab.
|
|---|---|---|
|
Percentage of Participants Achieving a Two-fold Increase CD3+ T Cells/μm2
|
40 percentage of participants
|
75 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 1 yearAdverse events with an attribution of possible, probable, or definite according to NCI Common Terminology Criteria for Adverse Events (CTCAE) v. 4 including immune-related AEs will be considered treatment related
Outcome measures
| Measure |
Pembrolizumab + Surgery
n=6 Participants
Patients will receive 200mg pembrolizumab on Day 1 of each 3 week cycle, for 2 cycles, prior to surgery. Pembrolizumab will be administered via IV infusion for 30 minutes. Surgery will occur no later than 6 weeks following the last dose of pembrolizumab.
|
Pembrolizumab + Radiation + Surgery
n=6 Participants
Patients will receive 200mg pembrolizumab on Day 1 of each 3 week cycle, for 2 cycles. Pembrolizumab will be administered via IV infusion for 30 minutes.Within the week (7 days +/- 3 days) following administration of the second cycle, a single 12 Gy dose of stereotactic radiation therapy (SRT) will be delivered to 50% of the primary tumor only. Definitive surgical resection will occur no later than 6 weeks following the last dose of pembrolizumab.
|
|---|---|---|
|
Percentage of Participants With Treatment-Related Adverse Events (AEs)
|
100 percentage of participants
|
83.3 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 1 yearImmune-related Adverse events with a Grade of 3 or higher according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4 will be reported
Outcome measures
| Measure |
Pembrolizumab + Surgery
n=6 Participants
Patients will receive 200mg pembrolizumab on Day 1 of each 3 week cycle, for 2 cycles, prior to surgery. Pembrolizumab will be administered via IV infusion for 30 minutes. Surgery will occur no later than 6 weeks following the last dose of pembrolizumab.
|
Pembrolizumab + Radiation + Surgery
n=6 Participants
Patients will receive 200mg pembrolizumab on Day 1 of each 3 week cycle, for 2 cycles. Pembrolizumab will be administered via IV infusion for 30 minutes.Within the week (7 days +/- 3 days) following administration of the second cycle, a single 12 Gy dose of stereotactic radiation therapy (SRT) will be delivered to 50% of the primary tumor only. Definitive surgical resection will occur no later than 6 weeks following the last dose of pembrolizumab.
|
|---|---|---|
|
Percentage of Participants With Grade 3 or Higher Immune-related AEs
|
16.66 percentage of participants
|
16.66 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: Censored observations are included in the calculation of the median survival time
Overall survival is defined as the time from treatment initiation until death in months with the median and full range reported. Participants lost to follow-up will be censored at the last study visit where survival data was obtained, and those still alive at 12 months will be censored.
Outcome measures
| Measure |
Pembrolizumab + Surgery
n=6 Participants
Patients will receive 200mg pembrolizumab on Day 1 of each 3 week cycle, for 2 cycles, prior to surgery. Pembrolizumab will be administered via IV infusion for 30 minutes. Surgery will occur no later than 6 weeks following the last dose of pembrolizumab.
|
Pembrolizumab + Radiation + Surgery
n=6 Participants
Patients will receive 200mg pembrolizumab on Day 1 of each 3 week cycle, for 2 cycles. Pembrolizumab will be administered via IV infusion for 30 minutes.Within the week (7 days +/- 3 days) following administration of the second cycle, a single 12 Gy dose of stereotactic radiation therapy (SRT) will be delivered to 50% of the primary tumor only. Definitive surgical resection will occur no later than 6 weeks following the last dose of pembrolizumab.
|
|---|---|---|
|
Median Overall Survival in Months
|
12 months
Interval 2.13 to 12.0
|
12 months
Interval 9.86 to 12.0
|
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: Censored observations are included in the calculation of the median survival time
Relapse free survival is defined as the time from treatment initiation until documented disease progression, in months, with the median and full range reported. Participants who have not progressed at the end of 12 months will be censored to the last study visit.
Outcome measures
| Measure |
Pembrolizumab + Surgery
n=6 Participants
Patients will receive 200mg pembrolizumab on Day 1 of each 3 week cycle, for 2 cycles, prior to surgery. Pembrolizumab will be administered via IV infusion for 30 minutes. Surgery will occur no later than 6 weeks following the last dose of pembrolizumab.
|
Pembrolizumab + Radiation + Surgery
n=6 Participants
Patients will receive 200mg pembrolizumab on Day 1 of each 3 week cycle, for 2 cycles. Pembrolizumab will be administered via IV infusion for 30 minutes.Within the week (7 days +/- 3 days) following administration of the second cycle, a single 12 Gy dose of stereotactic radiation therapy (SRT) will be delivered to 50% of the primary tumor only. Definitive surgical resection will occur no later than 6 weeks following the last dose of pembrolizumab.
|
|---|---|---|
|
Median Relapse Free Survival
|
12 months
Interval 2.13 to 12.0
|
12 months
Interval 9.86 to 12.0
|
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: Data not collected
The percentage of participants who demonstrated distant metastases at 12 months will be reported
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 1 yearThe percentage of participants with demonstrated progression that were determined to have tumor unresectability following the preoperative program will be reported.
Outcome measures
| Measure |
Pembrolizumab + Surgery
n=6 Participants
Patients will receive 200mg pembrolizumab on Day 1 of each 3 week cycle, for 2 cycles, prior to surgery. Pembrolizumab will be administered via IV infusion for 30 minutes. Surgery will occur no later than 6 weeks following the last dose of pembrolizumab.
|
Pembrolizumab + Radiation + Surgery
n=6 Participants
Patients will receive 200mg pembrolizumab on Day 1 of each 3 week cycle, for 2 cycles. Pembrolizumab will be administered via IV infusion for 30 minutes.Within the week (7 days +/- 3 days) following administration of the second cycle, a single 12 Gy dose of stereotactic radiation therapy (SRT) will be delivered to 50% of the primary tumor only. Definitive surgical resection will occur no later than 6 weeks following the last dose of pembrolizumab.
|
|---|---|---|
|
Percentage of Participants Determined to Have Unresectable Tumors After Progression
|
0 percentage of participants
|
0 percentage of participants
|
Adverse Events
Pembrolizumab + Surgery
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Pembrolizumab + Radiation + Surgery
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pembrolizumab + Surgery
n=6 participants at risk
Patients will receive 200mg pembrolizumab on Day 1 of each 3 week cycle, for 2 cycles, prior to surgery. Pembrolizumab will be administered via IV infusion for 30 minutes. Surgery will occur no later than 6 weeks following the last dose of pembrolizumab.
|
Pembrolizumab + Radiation + Surgery
n=6 participants at risk
Patients will receive 200mg pembrolizumab on Day 1 of each 3 week cycle, for 2 cycles. Pembrolizumab will be administered via IV infusion for 30 minutes.Within the week (7 days +/- 3 days) following administration of the second cycle, a single 12 Gy dose of stereotactic radiation therapy (SRT) will be delivered to 50% of the primary tumor only. Definitive surgical resection will occur no later than 6 weeks following the last dose of pembrolizumab.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal hemorrhage
|
16.7%
1/6 • Number of events 1 • Up to 1 year
|
0.00%
0/6 • Up to 1 year
|
|
General disorders
Fever
|
16.7%
1/6 • Number of events 1 • Up to 1 year
|
16.7%
1/6 • Number of events 1 • Up to 1 year
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/6 • Up to 1 year
|
16.7%
1/6 • Number of events 1 • Up to 1 year
|
Other adverse events
| Measure |
Pembrolizumab + Surgery
n=6 participants at risk
Patients will receive 200mg pembrolizumab on Day 1 of each 3 week cycle, for 2 cycles, prior to surgery. Pembrolizumab will be administered via IV infusion for 30 minutes. Surgery will occur no later than 6 weeks following the last dose of pembrolizumab.
|
Pembrolizumab + Radiation + Surgery
n=6 participants at risk
Patients will receive 200mg pembrolizumab on Day 1 of each 3 week cycle, for 2 cycles. Pembrolizumab will be administered via IV infusion for 30 minutes.Within the week (7 days +/- 3 days) following administration of the second cycle, a single 12 Gy dose of stereotactic radiation therapy (SRT) will be delivered to 50% of the primary tumor only. Definitive surgical resection will occur no later than 6 weeks following the last dose of pembrolizumab.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
3/6 • Number of events 3 • Up to 1 year
|
50.0%
3/6 • Number of events 3 • Up to 1 year
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • Up to 1 year
|
16.7%
1/6 • Number of events 1 • Up to 1 year
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/6 • Up to 1 year
|
16.7%
1/6 • Number of events 1 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
33.3%
2/6 • Number of events 2 • Up to 1 year
|
0.00%
0/6 • Up to 1 year
|
|
Reproductive system and breast disorders
Hypoxia
|
16.7%
1/6 • Number of events 1 • Up to 1 year
|
0.00%
0/6 • Up to 1 year
|
Additional Information
Dr. Sue Yom, MD, PhD
University of California, San Francisco
Phone: (415) 353-9893
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place