BENITIONSClinical Trial Intelligence

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

Phase 1/2 Active, not recruiting NCT04216316

ConditionLung Non-Small Cell Squamous Carcinoma, Stage IV Lung Cancer AJCC v8
PhasePhase 1/2
SponsorNational Cancer Institute (NCI)
StatusActive, not recruiting
Enrollment12 participants
InterventionsBerzosertib, Biospecimen Collection, Carboplatin, Computed Tomography, Gemcitabine Hydrochloride
Start dateApr 14, 2021
Completion dateMar 31, 2024
Results postedMar 24, 2026

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.

Patients Who Experienced a DLT

Up to completion of cycle 1 · percentage of patients

Dose Level -1 (Berzosertib (M6620) + Carboplatin + Gemcitabine + Pembrolizumab)0 percentage of patients
Dose Level 1 (Berzosertib (M6620) + Carboplatin + Gemcitabine + Pembrolizumab)33.3 percentage of patients

Recommended Phase 2 Dose (RP2D)

Up to completion of cycle 1 · mg/mL*min

Dose Level -1 (Berzosertib (M6620) + Carboplatin + Gemcitabine + Pembrolizumab)4 mg/mL*min

12-month Progression-free Survival (PFS) - Total Population

At 12 months · percentage of patients

Berzosertib (M6620) + Carboplatin + Gemcitabine + Pembrolizumab28 percentage of patients

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