Tuvusertib (M1774) in Combination With Cemiplimab in Participants With Non-Squamous NSCLC (DDRiver NSCLC 322)

Part of paid clinical trials in Santa Monica, California.

Sponsor
EMD Serono Research & Development Institute, Inc.
Study ID
NCT05882734
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • M1774 — DRUG
    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 — DRUG
    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.

Study Details

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..

Key Dates

Start date
Sep 13, 2023
Status verified
May 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
61 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dosing Regimen 1 (Phase 1b): M1774 + Cemiplimab
  • Experimental: Dosing Regimen 2 (Phase 1b): M1774 + Cemiplimab
  • Experimental: Stratum A (Phase 2a): Either Dosing Regimen 1 or 2 as finalized in Phase 1b
  • Experimental: Stratum B (Phase 2a): Either Dosing Regimen 1 or 2 as finalized in Phase 1b
  • Experimental: Stratum C (Phase 2a): Either Dosing Regimen 1 or 2 as finalized in Phase 1b

Primary Outcome Measure

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 ]

Locations (6)

FacilityCityStateZIPSite coordinators
UCLA Hematology and Oncology - Santa MonicaSanta MonicaCalifornia90404-
UPMC Cancer CenterPittsburghPennsylvania15232-
Tennessee Cancer Specialists - Biomedical ResearchKnoxvilleTennessee37909-
Millennium Research & Clinical DevelopmentHoustonTexas77090-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-
Virginia Cancer Specialists, PCFairfaxVirginia22031-

Find similar trials in Santa Monica, CA

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
UCLA Hematology and Oncology - Santa Monica· Santa Monica, CAUPMC Cancer Center· Pittsburgh, PATennessee Cancer Specialists - Biomedical Research· Knoxville, TNMillennium Research & Clinical Development· Houston, TXThe University of Texas MD Anderson Cancer Center· Houston, TXVirginia Cancer Specialists, PC· Fairfax, VA

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