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M1774

Phase 1

Non-Small Cell Lung Cancer | Small molecule | Oncology |Merck KGaA|Last Updated: May 28, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMC
Total Trials1
Total Enrollment61

FDA Designations

No designations recorded

Clinical trial landscape

M1774 · 1 trial · 1 indication

Phase 1 1
NCT05882734Tuvusertib (M1774) in Combination With Cemiplimab in Participants With Non-Squamous NSCLC (DDRiver NSCLC 322)Non-Small Cell Lung Cancer
ACTIVE NOT_RECRUITING61 Analytics
PHASE1ACTIVE NOT_RECRUITING
Tuvusertib (M1774) in Combination With Cemiplimab in Participants With Non-Squamous NSCLC (DDRiver NSCLC 322)
Non-Small Cell Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Phase 1b/Phase 2a: Confirmed Overall response (OR) According to Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 As assessed by Investigator
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 from randomization to final assessment at end of safety follow-up visit approximately up to 3 years and 2 months

Secondary Endpoints

Phase 1b/Phase 2a: Duration of Response (DoR) According to RECIST 1.1 as Assessed by the Investigator
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 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 from randomization to final assessment or until progression disease, death, discontinuation criteria approximately up to 3 years and 2 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Dosing Regimen 1 (Phase 1b): M1774 + CemiplimabEXPERIMENTAL -
Dosing Regimen 2 (Phase 1b): M1774 + CemiplimabEXPERIMENTAL -
Stratum A (Phase 2a): Either Dosing Regimen 1 or 2 as finalized in Phase 1bEXPERIMENTAL -
Stratum B (Phase 2a): Either Dosing Regimen 1 or 2 as finalized in Phase 1bEXPERIMENTAL -
Stratum C (Phase 2a): Either Dosing Regimen 1 or 2 as finalized in Phase 1bEXPERIMENTAL -

Interventions

NameTypeDescription
M1774DRUGIn 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.
CemiplimabDRUGCemiplimab 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.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites54

Inclusion Criteria: * Participants who are diagnosed with nsqNSCLC histologically or cytologically confirmed * Participants with Radiologically confirmed/documented disease progression during or after the following systemic therapies (all required): * At most, 1 line of anti-PD-(L)1 therapy for ...

Countries:United StatesBelgiumFranceGermanyItalyJapanSouth KoreaSpain
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Competitive Landscape -Non-Small Cell Lung Cancer 389 trials

Frequently asked questions about M1774

What is M1774 used for in Non-Small Cell Lung Cancer?

M1774, also known as tuvusertib, is an investigational small molecule being studied for the treatment of non-squamous Non-Small Cell Lung Cancer (NSCLC). It is currently in Phase 1 clinical development, evaluated in combination with cemiplimab in patients with this condition.

What does M1774 target?

M1774 is a small molecule developed by Merck KGaA. Its specific molecular target is not disclosed in the available information, so its mechanism of action is not described here. The drug is being investigated for its potential role in oncology, specifically in Non-Small Cell Lung Cancer.

Who makes M1774?

M1774 is developed by Merck KGaA, a German multinational pharmaceutical company traded under the ticker MKGAF. The drug is being studied in a Phase 1 clinical trial for Non-Small Cell Lung Cancer, with Merck KGaA as the sponsor.

What phase is M1774 in?

M1774 is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities. The ongoing trial is active but not recruiting participants, and it is evaluating M1774 in combination with cemiplimab for non-squamous Non-Small Cell Lung Cancer.

What clinical trials is M1774 in?

M1774 is being studied in one active Phase 1 clinical trial with the identifier NCT05882734. This trial, titled 'Tuvusertib (M1774) in Combination With Cemiplimab in Participants With Non-Squamous NSCLC (DDRiver NSCLC 322)', enrolls 61 participants across multiple countries including the United States, Belgium, France, Germany, Italy, Japan, South Korea, and Spain.

Is M1774 the same as tuvusertib?

Yes, M1774 is also known as tuvusertib. The clinical trial NCT05882734 uses the name 'Tuvusertib (M1774)' to refer to the same drug. This investigational small molecule is being developed by Merck KGaA for Non-Small Cell Lung Cancer.