Pembrolizumab in Treating Patients With EGFR Mutant, Tyrosine Kinase Inhibitor Naive Advanced Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT02879994|
Recruitment Status : Active, not recruiting
First Posted : August 26, 2016
Last Update Posted : August 15, 2018
|Condition or disease||Intervention/treatment||Phase|
|Stage IIIA Non-Small Cell Lung Cancer Stage IIIB Non-Small Cell Lung Cancer Stage IV Non-Small Cell Lung Cancer||Other: Laboratory Biomarker Analysis Biological: Pembrolizumab||Phase 2|
I. Determine efficacy (objective response rate [ORR]) of front-line pembrolizumab for metastatic EGFR mutation positive programmed cell death 1 ligand 1 (PD-L1)+ (> 1% by immunohistochemistry [IHC]) non-small cell lung cancer (NSCLC).
I. Determine safety (adverse event tabulation and grading) of front-line pembrolizumab for metastatic EGFR mutation positive PD-L1+ (> 1% by IHC) NSCLC.
II. Determine efficacy (progression free survival [PFS], overall survival [OS]) of front-line pembrolizumab for metastatic EGFR mutation positive PD-L1+ (>1% by IHC) NSCLC.
III. Determine ORR, PFS and OS of subsequent EGFR tyrosine kinase inhibitor (TKI) therapy in patients with EGFR-sensitizing mutation after pembrolizumab.
I. Analyze tumor tissue biomarkers for potential correlation with response.
Patients receive pembrolizumab intravenously (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.
After completion of study treatment, patients are followed up for up at 3 and 6 months, and then every 9 weeks thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Pembrolizumab in EGFR Mutant, Tyrosine Kinase Inhibitor Naïve Treatment Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)|
|Actual Study Start Date :||September 15, 2016|
|Estimated Primary Completion Date :||July 2019|
|Estimated Study Completion Date :||July 2020|
Experimental: 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.
Other: Laboratory Biomarker Analysis
- ORR determined as the proportion of patients achieving complete response or partial response as respectively defined in RECIST 1.1 [ Time Frame: Up to 3 years ]An exact binomial test to evaluate the response rate to the null hypothesis value of 0.10 will be used. A 95% confidence interval will be provided for the objective response rate of the population.
- Response duration defined as the proportion of patients achieving complete response or partial response by RECIST 1.1 [ Time Frame: Time from first documented evidence of response until progression, assessed for up to 3 years ]
- Incidence of adverse events according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 3 years ]Will be tabulated and graded.
- OS assessed by RECIST 1.1 [ Time Frame: Time from randomization to death by any cause, assessed for up to 3 years ]Will evaluate the relationship between PD-L1 expression at baseline with OS using Cox-proportional hazards regression.
- PFS assessed by RECIST 1.1 [ Time Frame: Time from randomization to first documented progression, assessed for up to 3 years ]Will evaluate the relationship between PD-L1 expression at baseline with PFS using Cox-proportional hazards regression.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02879994
|United States, California|
|UCLA / Jonsson Comprehensive Cancer Center|
|Los Angeles, California, United States, 90095|
|Principal Investigator:||Edward Garon||UCLA / Jonsson Comprehensive Cancer Center|