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

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 objective is to evaluate if total baseline tumor mutation burden (TMB) in cell-free circulating tumor deoxyribonucleic acid (ctDNA) 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.

Timeline

Start

2018-10-30

Primary completion

2021-11-05

Completion

2021-11-05

Publications

• Results Bar J, Esteban E, Rodriguez-Abreu D, Aix SP, Szalai Z, Felip E, Gottfried M, Provencio M, Robinson A, Fulop A, Rao SB, Camidge DR, Speranza G, Townson SM, Kobie J, Ayers M, Dettman EJ, Hunkapiller N, McDaniel R, Jung B, Burkhardt D, Mauntz R, Csoszi T. Blood tumor mutational burden and response to pembrolizumab plus chemotherapy in non-small cell lung cancer: KEYNOTE-782. Lung Cancer. 2024 Apr;190:107506. doi: 10.1016/j.lungcan.2024.107506. Epub 2024 Feb 17.

Drugs

Indications