Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-31 @ 7:44 PM
Study NCT ID:
NCT02879994
Status:
COMPLETED
Last Update Posted:
2021-07-14
First Post:
2016-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pembrolizumab in Treating Patients With EGFR Mutant, Tyrosine Kinase Inhibitor Naive Advanced Non-Small Cell Lung Cancer
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Study Overview
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)
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial studies how well pembrolizumab works in treating patients with epidermal growth factor receptor (EGFR) mutant non-small cell lung cancer that have not received prior tyrosine kinase inhibitor therapy and has spread to other places in the body. Monoclonal antibodies, such as pembrolizumab, may block growth in different ways by targeting certain cells.
Detailed Description:
PRIMARY OBJECTIVES:
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).
SECONDARY OBJECTIVES:
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.
TERTIARY OBJECTIVE:
I. Analyze tumor tissue biomarkers for potential correlation with response.
OUTLINE:
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.
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).
SECONDARY OBJECTIVES:
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.
TERTIARY OBJECTIVE:
I. Analyze tumor tissue biomarkers for potential correlation with response.
OUTLINE:
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: