Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2026-01-08 @ 7:17 AM
Study NCT ID:
NCT02955758
Status:
COMPLETED
Last Update Posted:
2024-10-09
First Post:
2016-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pembrolizumab in Patients With Metastatic Non-squamous Non-small Cell Lung Cancer
Sponsor:
Joel Neal
Organization:
Study Overview
Official Title:
A Phase 2 Trial of Pembrolizumab in Metastatic Non-squamous NSCLC Examining Circulating Tumor DNA Levels as a Surrogate Biomarker of Response
Status:
COMPLETED
Status Verified Date:
2024-09
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 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: