An open-label, multicenter, Phase 1b/2a study to evaluate efficacy, safety, tolerability, and pharmacokinetics of the ATR inhibitor Tuvusertib (M1774) in combination with cemiplimab in participants with non-squamous non-small cell lung cancer that has progressed on prior anti-PD-(L)1 and platinum-based therapies (DDRiver NSCLC 322)

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-502010-85-00

Acronym

MS201924_0022

Enrollment

170

Registered

2023-11-28

Start date

2023-12-20

Completion date

Unknown

Last updated

2026-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Squamous Non-Small Cell Lung Cancer

Brief summary

Phase 1b/Phase 2a: Confirmed Overall response (OR) According to Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 As assessed by Investigator, Phase 1b: Number of Participants With Adverse Events (AEs) and Treatment- related AEs

Detailed description

Phase 1b/Phase 2a: Duration of Response (DoR) According to RECIST 1.1 as Assessed by the Investigator, Phase 1b/Phase 2a: Progression Free Survival (PFS) According to RECIST 1.1 as Assessed by the Investigator, Phase 1b/Phase 2a: Overall survival (OS), Phase 2a: Number of Participants With AEs and Treatment-related AEs

Interventions

DRUGLIBTAYO 350 mg concentrate for solution for infusion.

DRUGM1774

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Phase 1b/Phase 2a: Confirmed Overall response (OR) According to Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 As assessed by Investigator, Phase 1b: Number of Participants With Adverse Events (AEs) and Treatment- related AEs	—

Secondary

Measure	Time frame
Phase 1b/Phase 2a: Duration of Response (DoR) According to RECIST 1.1 as Assessed by the Investigator, Phase 1b/Phase 2a: Progression Free Survival (PFS) According to RECIST 1.1 as Assessed by the Investigator, Phase 1b/Phase 2a: Overall survival (OS), Phase 2a: Number of Participants With AEs and Treatment-related AEs	—

Countries

Belgium, France, Germany, Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 6, 2026