Overview

Biomarkers of Response to Pembrolizumab Combined With Chemotherapy in Non-Small Cell Lung Cancer (KEYNOTE-782, MK-3475-782)

Status:
Active, not recruiting

Trial end date:
2023-08-23

Target enrollment:

Participant gender:

Summary

Participants with Stage IV nonsquamous non-small cell lung cancer (NSCLC) without prior systemic treatment will be treated with standard of care pembrolizumab combined with platinum-doublet chemotherapy for 4 cycles, then pembrolizumab plus pemetrexed maintenance for up to 31 additional cycles. The platinum doublet would be pemetrexed plus the investigator's choice of either cisplatin or carboplatin. The primary hypothesis is to evaluate if total baseline tumor mutation burden (TMB) in circulating free DNA (cfDNA) is predictive of objective response per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by the investigator by estimating the level of association.

Phase:

Phase 2

Details

Lead Sponsor:

Merck Sharp & Dohme Corp.

Treatments:

Carboplatin
Cisplatin
Pembrolizumab
Pemetrexed