Trial Outcomes & Findings for Pembrolizumab in Treating Patients With EGFR Mutant, Tyrosine Kinase Inhibitor Naive Advanced Non-Small Cell Lung Cancer (NCT NCT02879994)
NCT ID: NCT02879994
Last Updated: 2021-07-14
Results Overview
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by accessed by radiographic imaging: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
COMPLETED
PHASE2
11 participants
Up to 14 months
2021-07-14
Participant Flow
September 15, 2016 - October 24, 2018 Recruitment Period
Participant milestones
| Measure |
Treatment (Pembrolizumab)
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 35 courses in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
Treatment (Pembrolizumab)
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 35 courses in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Overall Study
off treatment early
|
7
|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Death
|
2
|
Baseline Characteristics
Pembrolizumab in Treating Patients With EGFR Mutant, Tyrosine Kinase Inhibitor Naive Advanced Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Pembrolizumab)
n=11 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 35 courses in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Age, Customized
18 - 21 years
|
0 Participants
n=99 Participants
|
|
Age, Customized
22 - 29 years
|
0 Participants
n=99 Participants
|
|
Age, Customized
30 - 39 years
|
1 Participants
n=99 Participants
|
|
Age, Customized
40 - 49 years
|
0 Participants
n=99 Participants
|
|
Age, Customized
50 - 59 years
|
3 Participants
n=99 Participants
|
|
Age, Customized
60 - 69 years
|
6 Participants
n=99 Participants
|
|
Age, Customized
70 - 79 years
|
1 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
5 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
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
6 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
United States
|
11 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to 14 monthsPopulation: Enrollment was ceased due to lack of efficacy after 11 of 25 planned patients were treated. Only 1 patient had an objective response, but repeat analysis of this patient's tumor definitively showed the original report of an epidermal growth factor receptor (EGFR) mutation to be erroneous.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by accessed by radiographic imaging: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Treatment (Pembrolizumab)
n=11 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 35 courses in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Overall Response Rate (ORR) Determined as the Percentage of Patients Achieving Complete Response or Partial Response as Respectively Defined in RECIST 1.1
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 14 MonthsPopulation: Enrollment was halted after 11 of 25 planned subjects due to lack of efficacy.
Number of Participants with Adverse Events According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Outcome measures
| Measure |
Treatment (Pembrolizumab)
n=11 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 35 courses in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Number of Participants With Adverse Events According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
|
11 Participants
|
SECONDARY outcome
Timeframe: assessed for up to 14 monthsPopulation: Participants analyzed is 10 because although 11 patients were treated, forensic analysis revealed that 1 subject did not have documented EGFR mutation. Regarding Overall Survival, median OS was not reached at time of data cutoff.
Will evaluate Progression Free Survival and Overall Survival. Average of Progression Free Survival recorded for limited number of subjects analyzed. 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 |
Treatment (Pembrolizumab)
n=10 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 35 courses in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Efficacy (Progression Free Survival (PFS) and Overall Survival (OS)) Assessed by RECIST 1.1
Progression free survival
|
119 days
Interval 42.0 to 123.0
|
Adverse Events
Treatment (Pembrolizumab)
Serious adverse events
| Measure |
Treatment (Pembrolizumab)
n=11 participants at risk
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 35 courses in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
9.1%
1/11 • Number of events 1 • Up to 14 months
Period of active patient enrollment
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
9.1%
1/11 • Number of events 1 • Up to 14 months
Period of active patient enrollment
|
|
Metabolism and nutrition disorders
Hypotension
|
9.1%
1/11 • Number of events 1 • Up to 14 months
Period of active patient enrollment
|
|
Blood and lymphatic system disorders
Hypercalcemia
|
9.1%
1/11 • Number of events 1 • Up to 14 months
Period of active patient enrollment
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
9.1%
1/11 • Number of events 1 • Up to 14 months
Period of active patient enrollment
|
|
Hepatobiliary disorders
Elevated alanine aminotransferase
|
9.1%
1/11 • Number of events 1 • Up to 14 months
Period of active patient enrollment
|
Other adverse events
| Measure |
Treatment (Pembrolizumab)
n=11 participants at risk
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 35 courses in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Skin and subcutaneous tissue disorders
Rash
|
27.3%
3/11 • Number of events 3 • Up to 14 months
Period of active patient enrollment
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
18.2%
2/11 • Number of events 2 • Up to 14 months
Period of active patient enrollment
|
|
Endocrine disorders
Adrenal insufficiency
|
9.1%
1/11 • Number of events 1 • Up to 14 months
Period of active patient enrollment
|
|
Gastrointestinal disorders
Diarrhea
|
18.2%
2/11 • Number of events 2 • Up to 14 months
Period of active patient enrollment
|
|
General disorders
Flu-like symptoms
|
18.2%
2/11 • Number of events 2 • Up to 14 months
Period of active patient enrollment
|
|
General disorders
Chills
|
9.1%
1/11 • Number of events 1 • Up to 14 months
Period of active patient enrollment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.1%
1/11 • Number of events 1 • Up to 14 months
Period of active patient enrollment
|
|
Gastrointestinal disorders
Hyperglycemia
|
9.1%
1/11 • Number of events 1 • Up to 14 months
Period of active patient enrollment
|
|
Psychiatric disorders
Anorexia
|
9.1%
1/11 • Number of events 1 • Up to 14 months
Period of active patient enrollment
|
|
Blood and lymphatic system disorders
Alanine aminotransferase increased
|
9.1%
1/11 • Number of events 1 • Up to 14 months
Period of active patient enrollment
|
|
Blood and lymphatic system disorders
Aspartate aminotransferase increased
|
9.1%
1/11 • Number of events 1 • Up to 14 months
Period of active patient enrollment
|
|
Blood and lymphatic system disorders
Thyroid-stimulating hormone decreased
|
9.1%
1/11 • Number of events 1 • Up to 14 months
Period of active patient enrollment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place