NCT02879994

Pembrolizumab in Treating Patients With EGFR Mutant, Tyrosine Kinase Inhibitor Naive Advanced Non-Small Cell Lung Cancer

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stage IIIA Non-Small Cell Lung Cancer
• Stage IIIB Non-Small Cell Lung Cancer
• Stage IV Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
OTHER	Laboratory Biomarker Analysis	Correlative studies
BIOLOGICAL	Pembrolizumab	Given IV

Timeline

• Start date: 2016-09-15
• Primary completion: 2017-11-30
• Completion: 2019-01-03
• First posted: 2016-08-26
• Last updated: 2021-07-14
• Results posted: 2021-07-14

Locations

1 site across 1 country: United States