NCT04165070PHASE1, PHASE2RECRUITING

KEYMAKER-U01 Substudy 01A: Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Chemotherapy When Used With Investigational Agents in Treatment-naïve Participants With Stage IV Non-small Cell Lung Cancer (NSCLC) (MK-3475-01A/KEYMAKER-U01A)

KEYMAKER-U01 Substudy 01A: A Phase 1/2, Umbrella Study With Rolling Arms of Investigational Agents With Pembrolizumab With or Without Chemotherapy in Treatment-Naive Participants With Stage IV 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

Pembrolizumab, Carboplatin, Paclitaxel, Pemetrexed

Enrollment

450 participants

Primary completion

Feb 2032

Study completion

Feb 2032

First posted

Nov 2019

Last updated

May 2026

Primary Endpoints (CT.gov)

Part A: Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

Time frame: Up to approximately 24 months

Part B: Number of Participants Who Experience One or More Adverse Events (AEs)

Time frame: Up to approximately 27 months

Part B: Number of Participants Who Discontinue Study Intervention Due to an Adverse Event (AE)

Time frame: Up to approximately 24 months

Part B: Number of Participants Who Experience a Dose Limiting Toxicity (DLT)

Time frame: Up to approximately 3 Weeks

Secondary Endpoints

Part A: Progression-Free Survival (PFS) According to RECIST 1.1

Part A: Number of Participants Who Experience One or More AEs

Part A: Number of Participants Who Discontinue Study Treatment Due to an AE

Eligibility Criteria

Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Has histologically- or cytologically-confirmed diagnosis of Stage IV squamous or nonsquamous NSCLC * Participants with nonsquamous NSCLC who are not eligible for an approved targeted therapy * Is able to provide archival tumor tissue sample collected either within 5 years or within the interval from completion of last treatment but before entering the screening period or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated obtained within 90 days of treatment initiation * Has not received prior systemic treatment for their metastatic NSCLC * Is able to complete all screening procedures within the 35-day screening window for Part A and 28-day screening window for Part B Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has a diagnosis of small cell lung cancer * Has a diagnosis of immunodeficiency or is receivi…

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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