Testing the Addition of an Anti-cancer Drug, Berzosertib (M6620, VX-970), to the Usual Treatments (Carboplatin and Gemcitabine) and to Pembrolizumab for Patients With Advanced Squamous Cell Non-small Cell Lung Cancer

Summary

This phase Ib/II trial studies the best dose of carboplatin when given together with berzosertib, gemcitabine and pembrolizumab and to see how well it works in treating patients with stage IV squamous cell non-small cell lung cancer that has spared to other placed in the body (advanced). Berzosertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as carboplatin and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving berzosertib together with carboplatin, gemcitabine, and pembrolizumab may work better in treating patients with squamous cell non-small cell lung cancer compared to carboplatin, gemcitabine, and pembrolizumab alone.

Timeline

Start

2021-04-14

Primary completion

2024-03-31

Completion

2027-03-18

Outcome

Met primary endpoint

paper berzosertib 135 mg/m2, carboplatin AUC 4, gemcitabine 800 mg/m2, and pembrolizumab 200 mg was the RP2D PMID 41206673 ↗

Publications

• Villaruz LC, Schluger B, Wang H, Ohr J, Petro D, Fuld AD, Herzberg B, Dawar R, Nieva J, Ruiz J, Christner SM, Holleran JL, Bakkenist CJ, Gore S, Beumer JH. Phase Ib study of berzosertib, carboplatin, gemcitabine, and pembrolizumab in patients with squamous nonsmall lung cancer (ETCTN 10313). Oncologist. 2025 Nov 11;30(11):oyaf373. doi: 10.1093/oncolo/oyaf373.

Drugs

Indications