Trial Outcomes & Findings for Phase II Study of Pembrolizumab After Curative Intent Treatment for Oligometastatic Non-Small Cell Lung Cancer (NCT NCT02316002)
NCT ID: NCT02316002
Last Updated: 2025-11-06
Results Overview
Time to progression or death from initiation of LAT
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
51 participants
Primary outcome timeframe
3 years
Results posted on
2025-11-06
Participant Flow
Participant milestones
| Measure |
Pembrolizumab
Pembrolizumab 200 mg every 3 weeks
Pembrolizumab
|
|---|---|
|
Overall Study
STARTED
|
51
|
|
Overall Study
COMPLETED
|
45
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase II Study of Pembrolizumab After Curative Intent Treatment for Oligometastatic Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Pembrolizumab
n=51 Participants
Pembrolizumab 200 mg every 3 weeks
Pembrolizumab
|
|---|---|
|
Age, Continuous
|
64 years
n=49 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=49 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=49 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=49 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=49 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=49 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=49 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=49 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=49 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=49 Participants
|
PRIMARY outcome
Timeframe: 3 yearsTime to progression or death from initiation of LAT
Outcome measures
| Measure |
Pembrolizumab
n=45 Participants
Pembrolizumab 200 mg every 3 weeks
Pembrolizumab
|
|---|---|
|
Progression Free Survival (PFS)
|
19.1 Months
Interval 9.4 to 28.7
|
Adverse Events
Pembrolizumab
Serious events: 15 serious events
Other events: 0 other events
Deaths: 11 deaths
Serious adverse events
| Measure |
Pembrolizumab
n=45 participants at risk
Pembrolizumab 200 mg every 3 weeks
Pembrolizumab
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
11.1%
5/45 • Number of events 5 • 2 years
As per CTCAE
|
|
Skin and subcutaneous tissue disorders
Rash
|
22.2%
10/45 • Number of events 10 • 2 years
As per CTCAE
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Joshua Bauml
University of Pennsylvania (Abramson Cancer Center)
Phone: 215-662-4000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place