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
| Condition | Lung Non-Small Cell Squamous Carcinoma, Stage IV Lung Cancer AJCC v8 |
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| Phase | Phase 1/2 |
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| Sponsor | National Cancer Institute (NCI) |
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| Status | Active, not recruiting |
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| Enrollment | 12 participants |
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| Interventions | Berzosertib, Biospecimen Collection, Carboplatin, Computed Tomography, Gemcitabine Hydrochloride |
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| Start date | Apr 14, 2021 |
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| Completion date | Mar 31, 2024 |
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| Results posted | Mar 24, 2026 |
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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 |
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| Dose Level 1 (Berzosertib (M6620) + Carboplatin + Gemcitabine + Pembrolizumab) | 33.3 percentage of patients |
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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 |
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12-month Progression-free Survival (PFS) - Total Population
At 12 months · percentage of patients
| Berzosertib (M6620) + Carboplatin + Gemcitabine + Pembrolizumab | 28 percentage of patients |
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Open in BENITIONS
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