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

Official Title

A Phase II Trial to Investigate Genetic Markers of Response to Pembrolizumab (MK-3475, SCH 900475) Combined With Chemotherapy as a First-line Treatment for Non-Small Cell Lung Cancer (KEYNOTE-782)

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 tumour mutation burden (TMB) in circulating free DNA (cfDNA) is predictive of objective response per Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1) by the investigator by estimating the level of association.

Trial Description

Primary Outcome:

  • Objective Response (OR)
  • Tumour Mutation Burden (TMB)
Secondary Outcome:
  • Progression Free Survival (PFS)
  • Overall Survival (OS)
  • Adverse Events (AEs)
  • Discontinuations from Study Drug Due to an Adverse Event

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society