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NCT06780098PHASE2RECRUITING

Substudy 01I: A Study of Investigational Agents in Participants With Previously Treated Stage IV Squamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-01I/KEYMAKER-U01I)

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

Sponsor: Merck Sharp & Dohme LLC + Daiichi Sankyo

No open prediction endpoints

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Key Facts

Study type
INTERVENTIONAL
Conditions
Lung Neoplasm
Interventions
R-DXD, I-DXD, Docetaxel, Rescue Medications
Enrollment
144 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

Number of participants who experience one or more adverse events (AEs)

Time frame: Up to approximately 81 months

Number of participants who discontinue study intervention due to an AE

Time frame: Up to approximately 81 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 squamous non-small cell lung cancer (NSCLC) * Has documented disease progression per Response Evaluation Criteria In Solid Tumors 1.1 (RECIST 1.1), as assessed by investigator after receiving an anti-programmed cell death protein 1 (anti-PD-1)/programmed cell death ligand 1 (PD-L1) treatment and platinum-based chemotherapy for Stage IV disease * Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART) * Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load * Participants with history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable Exclusion Criteria: The main exclusion criteria inclu

Read full criteria on CT.gov →

✦ Analyst Commentary

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

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Source

Open on ClinicalTrials.gov