This is an Open-label, multicenter clinical study conducted in two Phases to establish the efficacy, safety, tolerability, and pharmacokinetics of the ataxia telangiectasia mutated and Rad3-related protein kinase (ATR) inhibitor Tuvusertib in Combination with Cemiplimab in Participants with Non-Squamous Non-Small Cell Lung Cancer (nsqNSCLC) that has Progressed on Prior Anti-PD-(L)1 and Platinum-based Therapies..
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
61
In Phase 1b, M1774 will be administered as dosing regimen 1 or dosing regimen 2 until disease progression, death discontinuation criteria or any other reason. The selected dosing regimen of M1774 will be administered in all arms of Phase 2a.
Cemiplimab will be administered as an intravenous infusion every 3 weeks in all arms of Phase 1b and Phase 2a until disease progression, death discontinuation criteria or any other reason.
Phase 1b/Phase 2a: Confirmed Overall response (OR) According to Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 As assessed by Investigator
Time frame: Time from randomization to final assessment or until progression disease, death, discontinuation criteria approximately up to 3 years and 2 months
Phase 1b: Number of Participants With Adverse Events (AEs) and Treatment-related AEs
Time frame: Time from randomization to final assessment at end of safety follow-up visit approximately up to 3 years and 2 months
Phase 1b/Phase 2a: Duration of Response (DoR) According to RECIST 1.1 as Assessed by the Investigator
Time frame: Time from randomization to final assessment or until progression disease, death, discontinuation criteria approximately up to 3 years and 2 months
Phase 1b/Phase 2a: Progression Free Survival (PFS) According to RECIST 1.1 as Assessed by the Investigator
Time frame: Time from randomization to final assessment or until progression disease, death, discontinuation criteria approximately up to 3 years and 2 months
Phase 1b/Phase 2a: Overall survival (OS)
Time frame: Time from randomization to final assessment or until progression disease, death, discontinuation criteria approximately up to 3 years and 2 months
Phase 2a: Number of Participants With AEs and Treatment-related AEs
Time frame: Time from randomization to final assessment at end of safety follow-up visit (approximately up to 3 years and 2 months)
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