Trial Outcomes & Findings for Re-challenge Pembrolizumab Study as a Second or Further Line in Patients With Advanced NSCLC (NCT NCT03526887)
NCT ID: NCT03526887
Last Updated: 2025-03-24
Results Overview
Overall survival: Defined as the length of time from either the date of diagnosis or the start of the treatment that patients diagnosed with the disease are still alive.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
73 participants
Primary outcome timeframe
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months.
Results posted on
2025-03-24
Participant Flow
Participant milestones
| Measure |
Cohort 1
Patients who experienced progression disease while on treatment progression disease \< 12 weeks after stopping treatment. After that the patients took chemotherapy ≥ 4 cycles and progressed again. After the last progression the patient is included in the study to be retreated with Pembrolizumab 200mg
Pembrolizumab: 200 mg, Q3W
|
Cohort 2
Stop treatment and progression \> 12 weeks after stopping treatment. After the last progression the patient is included in the study to be retreated with Pembrolizumab 200mg
Pembrolizumab: 200 mg, Q3W
|
|---|---|---|
|
Overall Study
STARTED
|
55
|
18
|
|
Overall Study
COMPLETED
|
55
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Re-challenge Pembrolizumab Study as a Second or Further Line in Patients With Advanced NSCLC
Baseline characteristics by cohort
| Measure |
Cohort 1
n=55 Participants
Patients who experienced progression disease while on treatment progression disease \< 12 weeks after stopping treatment. After that the patients took chemotherapy ≥ 4 cycles and progressed again. After the last progression the patient is included in the study to be retreated with Pembrolizumab 200mg
Pembrolizumab: 200 mg, Q3W
|
Cohort 2
n=18 Participants
Stop treatment and progression \> 12 weeks after stopping treatment. After the last progression the patient is included in the study to be retreated with Pembrolizumab 200mg
Pembrolizumab: 200 mg, Q3W
|
Total
n=73 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.5 years
n=99 Participants
|
69.8 years
n=107 Participants
|
65 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
53 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
71 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
Spain
|
55 participants
n=99 Participants
|
18 participants
n=107 Participants
|
73 participants
n=206 Participants
|
|
Performance Status
ECOG 0
|
15 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Performance Status
ECOG 1
|
39 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
|
Performance Status
ECOG 2
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Performance Status
ECOG 3
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Performance Status
ECOG4
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Performance Status
Not recorded
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Cigarette Smoking History
Never smoker
|
7 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Cigarette Smoking History
Former smoker
|
39 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
|
Cigarette Smoking History
Smoker
|
8 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Cigarette Smoking History
Not recorded
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Body Mass Index
|
26 kg/m^2
n=99 Participants
|
28 kg/m^2
n=107 Participants
|
26.5 kg/m^2
n=206 Participants
|
|
Histology
Adenocarcinoma
|
32 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Histology
Squamous
|
19 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Histology
Adeno-squamous
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Histology
Large Cell Carcinoma
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Histology
NOS/Undifferentiated
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Histology
Other
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Clinical Stage
Stage I
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Clinical Stage
Stage II
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Clinical Stage
Stage III
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Clinical Stage
Stage IV
|
52 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
69 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months.Overall survival: Defined as the length of time from either the date of diagnosis or the start of the treatment that patients diagnosed with the disease are still alive.
Outcome measures
| Measure |
Cohort 1
n=55 Participants
Patients who experienced progression disease while on treatment progression disease \< 12 weeks after stopping treatment. After that the patients took chemotherapy ≥ 4 cycles and progressed again. After the last progression the patient is included in the study to be retreated with Pembrolizumab 200mg
Pembrolizumab: 200 mg, Q3W
|
Cohort 2
n=18 Participants
Stop treatment and progression \> 12 weeks after stopping treatment. After the last progression the patient is included in the study to be retreated with Pembrolizumab 200mg
Pembrolizumab: 200 mg, Q3W
|
|---|---|---|
|
Efficacy of Pembrolizumab Re-challenge Measured by Overall Survival
|
9.4 months
Interval 1.0 to 18.0
|
19.1 months
Interval 3.0 to 48.0
|
SECONDARY outcome
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.PFS: Defined as the length of time from the date of randomization to the date of the first documented progression of disease. "Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions"
Outcome measures
| Measure |
Cohort 1
n=55 Participants
Patients who experienced progression disease while on treatment progression disease \< 12 weeks after stopping treatment. After that the patients took chemotherapy ≥ 4 cycles and progressed again. After the last progression the patient is included in the study to be retreated with Pembrolizumab 200mg
Pembrolizumab: 200 mg, Q3W
|
Cohort 2
n=18 Participants
Stop treatment and progression \> 12 weeks after stopping treatment. After the last progression the patient is included in the study to be retreated with Pembrolizumab 200mg
Pembrolizumab: 200 mg, Q3W
|
|---|---|---|
|
Efficacy of Pembrolizumab Re-challenge Measured by Progression Free Survival (PFS) Per RECIST v1.1.
|
1.6 months
Interval 0.0 to 11.0
|
4.1 months
Interval 0.2 to 18.0
|
SECONDARY outcome
Timeframe: From the date of randomization until end of follow up, up to 36 monthsTo evaluate the best global response of the treatment as measured by investigator-assessed overall response rate (ORR) according to RECIST v1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Cohort 1
n=55 Participants
Patients who experienced progression disease while on treatment progression disease \< 12 weeks after stopping treatment. After that the patients took chemotherapy ≥ 4 cycles and progressed again. After the last progression the patient is included in the study to be retreated with Pembrolizumab 200mg
Pembrolizumab: 200 mg, Q3W
|
Cohort 2
n=18 Participants
Stop treatment and progression \> 12 weeks after stopping treatment. After the last progression the patient is included in the study to be retreated with Pembrolizumab 200mg
Pembrolizumab: 200 mg, Q3W
|
|---|---|---|
|
Best Global Response
Complete response
|
0 Participants
|
0 Participants
|
|
Best Global Response
Partial response
|
1 Participants
|
3 Participants
|
|
Best Global Response
Stable disease
|
24 Participants
|
11 Participants
|
|
Best Global Response
Progression disease
|
25 Participants
|
3 Participants
|
|
Best Global Response
Not evaluable
|
5 Participants
|
1 Participants
|
Adverse Events
Cohort 1
Serious events: 2 serious events
Other events: 29 other events
Deaths: 44 deaths
Cohort 2
Serious events: 1 serious events
Other events: 11 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Cohort 1
n=55 participants at risk
Patients who experienced progression disease while on treatment progression disease \< 12 weeks after stopping treatment. After that the patients took chemotherapy ≥ 4 cycles and progressed again. After the last progression the patient is included in the study to be retreated with Pembrolizumab 200mg
Pembrolizumab: 200 mg, Q3W
|
Cohort 2
n=18 participants at risk
Stop treatment and progression \> 12 weeks after stopping treatment. After the last progression the patient is included in the study to be retreated with Pembrolizumab 200mg
Pembrolizumab: 200 mg, Q3W
|
|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/55 • Adverse Events were assessed an average of 30 months. Deaths were assessed up to 48 months.
Any adverse event or breakdown occurring during the course of the study. The investigator will have to collect all adverse events once they have signed informed consent, during treatment and 30 days after the last dose study treatment administration.
|
5.6%
1/18 • Number of events 1 • Adverse Events were assessed an average of 30 months. Deaths were assessed up to 48 months.
Any adverse event or breakdown occurring during the course of the study. The investigator will have to collect all adverse events once they have signed informed consent, during treatment and 30 days after the last dose study treatment administration.
|
|
Blood and lymphatic system disorders
Alkaline phosphatase increased
|
1.8%
1/55 • Number of events 1 • Adverse Events were assessed an average of 30 months. Deaths were assessed up to 48 months.
Any adverse event or breakdown occurring during the course of the study. The investigator will have to collect all adverse events once they have signed informed consent, during treatment and 30 days after the last dose study treatment administration.
|
0.00%
0/18 • Adverse Events were assessed an average of 30 months. Deaths were assessed up to 48 months.
Any adverse event or breakdown occurring during the course of the study. The investigator will have to collect all adverse events once they have signed informed consent, during treatment and 30 days after the last dose study treatment administration.
|
|
Blood and lymphatic system disorders
Blood bilirubin increased
|
1.8%
1/55 • Number of events 1 • Adverse Events were assessed an average of 30 months. Deaths were assessed up to 48 months.
Any adverse event or breakdown occurring during the course of the study. The investigator will have to collect all adverse events once they have signed informed consent, during treatment and 30 days after the last dose study treatment administration.
|
0.00%
0/18 • Adverse Events were assessed an average of 30 months. Deaths were assessed up to 48 months.
Any adverse event or breakdown occurring during the course of the study. The investigator will have to collect all adverse events once they have signed informed consent, during treatment and 30 days after the last dose study treatment administration.
|
Other adverse events
| Measure |
Cohort 1
n=55 participants at risk
Patients who experienced progression disease while on treatment progression disease \< 12 weeks after stopping treatment. After that the patients took chemotherapy ≥ 4 cycles and progressed again. After the last progression the patient is included in the study to be retreated with Pembrolizumab 200mg
Pembrolizumab: 200 mg, Q3W
|
Cohort 2
n=18 participants at risk
Stop treatment and progression \> 12 weeks after stopping treatment. After the last progression the patient is included in the study to be retreated with Pembrolizumab 200mg
Pembrolizumab: 200 mg, Q3W
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
14.5%
8/55 • Number of events 8 • Adverse Events were assessed an average of 30 months. Deaths were assessed up to 48 months.
Any adverse event or breakdown occurring during the course of the study. The investigator will have to collect all adverse events once they have signed informed consent, during treatment and 30 days after the last dose study treatment administration.
|
5.6%
1/18 • Number of events 1 • Adverse Events were assessed an average of 30 months. Deaths were assessed up to 48 months.
Any adverse event or breakdown occurring during the course of the study. The investigator will have to collect all adverse events once they have signed informed consent, during treatment and 30 days after the last dose study treatment administration.
|
|
Gastrointestinal disorders
Nausea
|
7.3%
4/55 • Number of events 4 • Adverse Events were assessed an average of 30 months. Deaths were assessed up to 48 months.
Any adverse event or breakdown occurring during the course of the study. The investigator will have to collect all adverse events once they have signed informed consent, during treatment and 30 days after the last dose study treatment administration.
|
5.6%
1/18 • Number of events 1 • Adverse Events were assessed an average of 30 months. Deaths were assessed up to 48 months.
Any adverse event or breakdown occurring during the course of the study. The investigator will have to collect all adverse events once they have signed informed consent, during treatment and 30 days after the last dose study treatment administration.
|
|
Gastrointestinal disorders
Stomach pain
|
5.5%
3/55 • Number of events 3 • Adverse Events were assessed an average of 30 months. Deaths were assessed up to 48 months.
Any adverse event or breakdown occurring during the course of the study. The investigator will have to collect all adverse events once they have signed informed consent, during treatment and 30 days after the last dose study treatment administration.
|
0.00%
0/18 • Adverse Events were assessed an average of 30 months. Deaths were assessed up to 48 months.
Any adverse event or breakdown occurring during the course of the study. The investigator will have to collect all adverse events once they have signed informed consent, during treatment and 30 days after the last dose study treatment administration.
|
|
General disorders
Fatigue
|
12.7%
7/55 • Number of events 7 • Adverse Events were assessed an average of 30 months. Deaths were assessed up to 48 months.
Any adverse event or breakdown occurring during the course of the study. The investigator will have to collect all adverse events once they have signed informed consent, during treatment and 30 days after the last dose study treatment administration.
|
22.2%
4/18 • Number of events 4 • Adverse Events were assessed an average of 30 months. Deaths were assessed up to 48 months.
Any adverse event or breakdown occurring during the course of the study. The investigator will have to collect all adverse events once they have signed informed consent, during treatment and 30 days after the last dose study treatment administration.
|
|
Blood and lymphatic system disorders
Alanine aminotransferase increased
|
5.5%
3/55 • Number of events 3 • Adverse Events were assessed an average of 30 months. Deaths were assessed up to 48 months.
Any adverse event or breakdown occurring during the course of the study. The investigator will have to collect all adverse events once they have signed informed consent, during treatment and 30 days after the last dose study treatment administration.
|
5.6%
1/18 • Number of events 1 • Adverse Events were assessed an average of 30 months. Deaths were assessed up to 48 months.
Any adverse event or breakdown occurring during the course of the study. The investigator will have to collect all adverse events once they have signed informed consent, during treatment and 30 days after the last dose study treatment administration.
|
|
Investigations
Aspartate aminotransferase increased
|
5.5%
3/55 • Number of events 3 • Adverse Events were assessed an average of 30 months. Deaths were assessed up to 48 months.
Any adverse event or breakdown occurring during the course of the study. The investigator will have to collect all adverse events once they have signed informed consent, during treatment and 30 days after the last dose study treatment administration.
|
11.1%
2/18 • Number of events 2 • Adverse Events were assessed an average of 30 months. Deaths were assessed up to 48 months.
Any adverse event or breakdown occurring during the course of the study. The investigator will have to collect all adverse events once they have signed informed consent, during treatment and 30 days after the last dose study treatment administration.
|
|
Investigations
Blood bilirubin increased
|
5.5%
3/55 • Number of events 3 • Adverse Events were assessed an average of 30 months. Deaths were assessed up to 48 months.
Any adverse event or breakdown occurring during the course of the study. The investigator will have to collect all adverse events once they have signed informed consent, during treatment and 30 days after the last dose study treatment administration.
|
5.6%
1/18 • Number of events 1 • Adverse Events were assessed an average of 30 months. Deaths were assessed up to 48 months.
Any adverse event or breakdown occurring during the course of the study. The investigator will have to collect all adverse events once they have signed informed consent, during treatment and 30 days after the last dose study treatment administration.
|
|
Metabolism and nutrition disorders
Anorexia
|
5.5%
3/55 • Number of events 3 • Adverse Events were assessed an average of 30 months. Deaths were assessed up to 48 months.
Any adverse event or breakdown occurring during the course of the study. The investigator will have to collect all adverse events once they have signed informed consent, during treatment and 30 days after the last dose study treatment administration.
|
0.00%
0/18 • Adverse Events were assessed an average of 30 months. Deaths were assessed up to 48 months.
Any adverse event or breakdown occurring during the course of the study. The investigator will have to collect all adverse events once they have signed informed consent, during treatment and 30 days after the last dose study treatment administration.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.5%
3/55 • Number of events 3 • Adverse Events were assessed an average of 30 months. Deaths were assessed up to 48 months.
Any adverse event or breakdown occurring during the course of the study. The investigator will have to collect all adverse events once they have signed informed consent, during treatment and 30 days after the last dose study treatment administration.
|
5.6%
1/18 • Number of events 1 • Adverse Events were assessed an average of 30 months. Deaths were assessed up to 48 months.
Any adverse event or breakdown occurring during the course of the study. The investigator will have to collect all adverse events once they have signed informed consent, during treatment and 30 days after the last dose study treatment administration.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.1%
5/55 • Number of events 5 • Adverse Events were assessed an average of 30 months. Deaths were assessed up to 48 months.
Any adverse event or breakdown occurring during the course of the study. The investigator will have to collect all adverse events once they have signed informed consent, during treatment and 30 days after the last dose study treatment administration.
|
16.7%
3/18 • Number of events 3 • Adverse Events were assessed an average of 30 months. Deaths were assessed up to 48 months.
Any adverse event or breakdown occurring during the course of the study. The investigator will have to collect all adverse events once they have signed informed consent, during treatment and 30 days after the last dose study treatment administration.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.5%
3/55 • Number of events 3 • Adverse Events were assessed an average of 30 months. Deaths were assessed up to 48 months.
Any adverse event or breakdown occurring during the course of the study. The investigator will have to collect all adverse events once they have signed informed consent, during treatment and 30 days after the last dose study treatment administration.
|
5.6%
1/18 • Number of events 1 • Adverse Events were assessed an average of 30 months. Deaths were assessed up to 48 months.
Any adverse event or breakdown occurring during the course of the study. The investigator will have to collect all adverse events once they have signed informed consent, during treatment and 30 days after the last dose study treatment administration.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
5.5%
3/55 • Number of events 3 • Adverse Events were assessed an average of 30 months. Deaths were assessed up to 48 months.
Any adverse event or breakdown occurring during the course of the study. The investigator will have to collect all adverse events once they have signed informed consent, during treatment and 30 days after the last dose study treatment administration.
|
0.00%
0/18 • Adverse Events were assessed an average of 30 months. Deaths were assessed up to 48 months.
Any adverse event or breakdown occurring during the course of the study. The investigator will have to collect all adverse events once they have signed informed consent, during treatment and 30 days after the last dose study treatment administration.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place