ArticleThe oncologist2025
Phase Ib study of berzosertib, carboplatin, gemcitabine, and pembrolizumab in patients with squamous nonsmall lung cancer (ETCTN 10313).
Article in The oncologist, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04216316 (A Phase IB and Randomized Open-Label Phase II Study of Berzosertib), which is not on this map. Cited by 1 paper.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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
Who cites it
1 citing paper in PubMed.
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Authors and funding
15 authors.
Funding
Abstract
backgroundBerzosertib is a potent and selective inhibitor of ataxia telangiectasia Rad3-related and potentiates cisplatin and gemcitabine in lung xenografts. We hypothesized that berzosertib plus carboplatin, gemcitabine, and pembrolizumab is tolerable and active in newly diagnosed advanced squamous NSCLC.
methodsThis phase Ib clinical trial studied berzosertib 135 mg/m2 IV Days 2 and 9 with carboplatin AUC 4-5 Day 1, gemcitabine 800 mg/m2 Days 1 and 8, and pembrolizumab 200 mg Day 1, of a 3-week cycle. Primary endpoint was the recommended phase II dose (RP2D). Antitumor activity and pharmacokinetics were secondary endpoints.
resultsTwelve patients were enrolled and treated. Two of six patients at DL 1 (berzosertib 135 mg/m2, carboplatin area under the curve (AUC) 5, gemcitabine 800 mg/m2, and pembrolizumab 200 mg) experienced a dose-limiting toxicity: grade 5 gastric hemorrhage upon intractable nausea and vomiting; grade 3 neutropenia resulting in treatment delay. None of 6 patients experienced a DLT at DL-1 (berzosertib 135 mg/m2, carboplatin AUC 4, gemcitabine 800 mg/m2, and pembrolizumab 200 mg). The most common grade ≥3 TRAEs were leukopenia (75%), neutropenia (67%), anemia (58%), thrombocytopenia (33%), and lymphopenia (33%). Berzosertib and gemcitabine exposure did not correlate with the highest grade cycle 1 toxicity. Five of eleven evaluable patients (46%) experienced partial response.
conclusionIn newly diagnosed advanced squamous non-small cell lung cancer (NSCLC), berzosertib 135 mg/m2, carboplatin AUC 4, gemcitabine 800 mg/m2, and pembrolizumab 200 mg was the RP2D, which was both tolerable and associated with activity. This study did not proceed to phase II upon discontinuation of berzosertib development. Clinicaltrials.gov Identifier: NCT04216316.
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