NCT02955758

Pembrolizumab in Patients With Metastatic Non-squamous Non-small Cell Lung Cancer

A Phase 2 Trial of Pembrolizumab in Metastatic Non-squamous NSCLC Examining Circulating Tumor DNA Levels as a Surrogate Biomarker of Response

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Joel Neal · 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 non-squamous non-small cell lung cancer which has spread to other places in the body. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread.

Detailed description

PRIMARY OBJECTIVES: I. To correlate circulating tumor DNA (ctDNA) levels measured using cancer personalized profiling by deep sequencing (CAPP-Seq) with radiographic tumor assessments using Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 criteria in patients with metastatic non-squamous non-small cell lung cancer (NSCLC) treated with pembrolizumab. SECONDARY OBJECTIVES: I. To correlate PD-L1 assessment on pre-treatment tumor samples with objective response using RECIST v1.1 criteria in patients with metastatic non-squamous NSCLC treated with pembrolizumab. II. To determine the overall response rate (ORR) using RECIST v1.1 criteria in patients with metastatic non-squamous NSCLC treated with pembrolizumab. III. To determine the progression-free survival (PFS) using RECIST v1.1 in patients with metastatic non-squamous NSCLC treated with pembrolizumab. IV. To determine the overall survival (OS) in patients with metastatic non-squamous NSCLC treated with pembrolizumab. V. To determine the safety and tolerability of pembrolizumab in patients with metastatic non-squamous NSCLC.

Conditions

• Metastatic Non-Squamous Non-Small Cell Lung Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	Pembrolizumab	Given IV, 200mg fixed dose, every 3 weeks

Timeline

• Start date: 2016-10-01
• Primary completion: 2024-04-09
• Completion: 2024-04-09
• First posted: 2016-11-04
• Last updated: 2024-10-09
• Results posted: 2024-10-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study