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KEYMAKER-U01 Substudy 01A for Stage IV Non-Small Cell Lung Cancer

This study is testing the effectiveness and safety of pembrolizumab, an immunotherapy, with or without chemotherapy (carboplatin, paclitaxel, or pemetrexed). These treatments are combined with other investigational drugs like vibostolimab, boserolimab, MK-4830, MK-0482, I-DXd, or HER3-DXd. This is for people newly diagnosed with advanced (Stage IV) non-small cell lung cancer (NSCLC) who haven't received prior treatment. The study aims to see how many participants respond to the treatment and to track any side effects. You may be able to join if you are 18 or older, have Stage IV NSCLC, and can provide a tumor tissue sample.

Study design
This interventional study plans to enroll 450 participants. It is part of a larger research program for pembrolizumab.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for adverse events for up to approximately 27 months, and for treatment discontinuation due to adverse events for up to approximately 24 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04165070

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)

Recruiting
PHASE1Ages 18+InterventionalTreatment
Merck Sharp & Dohme LLC
~450 participants
Updated 2026-08-25 on ClinicalTrials.gov
What's tested:PembrolizumabCarboplatinPaclitaxelPemetrexedVibostolimabBoserolimab

At a glance

Recruiting sites
15 of 46 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part A: Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Measured over Up to approximately 24 months
+3 more outcomes measured

Conditions

Carcinoma, Non-Small-Cell Lung

Explore related trials

Lung Non-Small Cell Carcinoma

Where it's being run

46 sites across 33 states
Israel7
Taiwan3
California2
Massachusetts2
Ohio2
Italy2
South Korea2
Arizona1

Study leadership

  • Medical Director · STUDY_DIRECTOR · Merck Sharp & Dohme LLC

Who to contact

Toll Free Number
[email protected]
1-888-577-8839
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Has a diagnosis of small cell lung cancer
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days before the first dose of study treatment
Has a known additional malignancy that is progressing or has required active treatment within the past 2 years
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
Has an active autoimmune disease that has required systemic treatment in the past 2 years
Has a history of (noninfectious) pneumonitis that required steroids or has current pneumonitis
Has an active infection requiring systemic therapy
Has clinically significant cardiac disease, including unstable angina, acute myocardial infarction within 6 months from Day 1 of study treatment administration, or New York Heart Association Class III or IV congestive heart failure
Has a known history of human immunodeficiency virus (HIV) infection. Well-controlled HIV with anti-retroviral therapy (ART) is not excluded
Has a known history of Hepatitis B (HPV) or known active Hepatitis C virus infection. Hepatitis B surface antigen (HBsAg) positive is eligible if on HBV antiviral therapy for at least 4 weeks and HBV viral load is undetectable prior to randomization
Has had major surgery \<3 weeks before the first dose of study treatment
Is expected to require any other form of antineoplastic therapy while on study
Has a history or current evidence of a gastrointestinal (GI) condition (e.g. inflammatory bowel disease, Crohn's disease, ulcerative colitis) or impaired liver function or diseases that in the opinion of the investigator may significantly alter the absorption or metabolism of oral medications
Is getting chemotherapy and has clinically active diverticulitis, intra-abdominal abscess, GI obstruction, or peritoneal carcinomatosis
Has preexisting neuropathy that is moderate in intensity
Has received prior systemic cytotoxic chemotherapy or other targeted or biological antineoplastic therapy for metastatic disease
Is unable or unwilling to take folic acid or vitamin B12 supplementation, for participants who will receive pemetrexed
Has a known sensitivity to any component of carboplatin, paclitaxel, pemetrexed or any of their excipients
Has received prior radiation therapy to the lung that is \>30 Gray (Gy) within 6 months of the first dose of study treatment
Has received a live vaccine within 30 days before the first dose of study treatment. Any licensed COVID-19 vaccine (including for Emergency Use) in a particular country is allowed as long as they are messenger ribonucleic acid (mRNA) vaccines, adenoviral vaccines, or inactivated vaccines. Investigational vaccines (ie, those not licensed or approved for Emergency Use) are not allowed
Has received any prior immunotherapy and was discontinued from that treatment due to a severe or worse immune-related adverse event (irAE)
Has had chemotherapy or biological cancer therapy within 4 weeks before the first dose of study treatment or has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or better from the AEs due to cancer therapeutics administered more than 4 weeks before the first dose of study treatment (including participants who had previous immunomodulatory therapy with residual irAEs)
Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study treatment
Previously had a severe hypersensitivity reaction to treatment with monoclonal antibodies (including pembrolizumab) and/or any of their excipients
Has had an allogenic tissue/solid organ transplant

What this trial measures

  • Part A: Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)Up to approximately 24 months

    ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1. ORR will be reported.

  • Part B: Number of Participants Who Experience One or More Adverse Events (AEs)Up to approximately 27 months

    An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who experience an AE will be reported.

  • Part B: Number of Participants Who Discontinue Study Intervention Due to an Adverse Event (AE)Up to approximately 24 months

    An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who discontinue study intervention due to an AE will be reported.

  • Part B: Number of Participants Who Experience a Dose Limiting Toxicity (DLT)Up to approximately 3 Weeks

    A DLT is defined as an event with toxicity including the type, severity, time of onset, time of resolution, and the probable association with study treatment that are not due to pre-existing conditions as defined by the Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE 5.0). Number of participants who experience a DLT per CTCAE 5.0 will be reported.