NCT06780085PHASE2RECRUITING

A Study of Investigational Agents in Participants With Previously Treated Stage IV Nonsquamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-01H/KEYMAKER-U01)

KEYMAKER-U01 Substudy 01H: A Phase 2, Randomized, Umbrella Study With Rolling Arms of Investigational Agents in Participants With Previously Treated Stage IV Nonsquamous Non-small Cell Lung Cancer (NSCLC)

Sponsor: Merck Sharp & Dohme LLC + Daiichi Sankyo

No open prediction endpoints

Endpoints are classified and published by ProgramSignal analysts.

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Key Facts

Study type

INTERVENTIONAL

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Raludotatug Deruxtecan, Ifinatamab Deruxtecan, Docetetaxel, 5-hydroxytryptamine subtype 3 receptor antagonist

Enrollment

96 participants

Primary completion

Mar 2032

Study completion

Mar 2032

First posted

Jan 2025

Last updated

May 2026

Primary Endpoints (CT.gov)

Objective Response Rate (ORR)

Time frame: Up to approximately 81 months

Percentage of Participants with at Least One Adverse Event (AE)

Time frame: Up to approximately 81 months

Percentage of Participants Who Discontinued Medication Due to an AE

Time frame: Up to approximately 24 months

Secondary Endpoints

Duration of Response (DOR)

Progression-free Survival (PFS)

Overall Survival (OS)

Eligibility Criteria

Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Histologically or cytologically confirmed diagnosis of Stage IV nonsquamous non-small cell lung cancer (NSCLC) * Documented disease progression per RECIST 1.1 after receiving an anti-programmed cell death 1 protein (PD-1)/programmed cell death ligand 1 (PD-L1) treatment and platinum-based chemotherapy * Confirmation per local test report that epidermal growth factor receptor negative (EGFR-), anaplastic lymphoma kinase negative (ALK-), c ros oncogene 1 negative (ROS1-), or other directed therapy is not indicated as primary therapy * Measurable disease per RECIST 1.1 as assessed by investigator and verified by BICR * Life expectancy of at least 3 months * An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization * Is an individual of any sex/gender who is at least 18 years of age at the time of providing the informed consent * Has …

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✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

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Source

Open on ClinicalTrials.gov