CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 12 enrolled
Drug / intervention
Berzosertib +6 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04216316
NCT04216316Phase 2Active

A Phase IB and Randomized Open-Label Phase II Study of Berzosertib (M6620, VX-970) in Combination With Carboplatin/Gemcitabine/Pembrolizumab in Patients With Chemotherapy-Naïve Advanced Non-Small Cell Lung Cancer of Squamous Cell Histology

National Cancer Institute (NCI)·interventional·Posted Jan 2, 2020·Updated May 28, 2026

In Brief

A Phase 2 clinical trial evaluating Berzosertib, Biospecimen Collection, and 5 other interventions for Lung Non-Small Cell Squamous Carcinoma and Stage IV Lung Cancer AJCC v8. Active but no longer recruiting, targeting 12 participants across 34 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2Active
20202021202220232024202520262027
First PostedJan 2, 2020
Enrollment StartApr 14, 2021
Primary CompletionMar 31, 2024
Study CompletionMar 18, 2027
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 6.5 years ago

Interventions

Berzosertibdrug

Given IV

Biospecimen Collectionprocedure

Correlative studies

Carboplatindrug

Given IV

Computed Tomographyprocedure

Undergo CT

Gemcitabine Hydrochloridedrug

Given IV

Magnetic Resonance Imagingprocedure

Undergo MRI

Pembrolizumabbiological

Given IV