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Study of Pembrolizumab with or without Chemotherapy for Advanced Non-Small Cell Lung Cancer

This study is for people with untreated advanced non-small cell lung cancer (NSCLC), which is lung cancer that has spread. Researchers are looking at different combinations of treatments. You might receive pembrolizumab (an immunotherapy), with or without chemotherapy drugs like carboplatin, paclitaxel, nab-paclitaxel, or pemetrexed. The study also explores adding other treatments, such as patritumab deruxtecan. The main goals are to see how safe these treatments are and how well they work in shrinking the cancer. To join, you must have Stage IV NSCLC confirmed by a biopsy. The study plans to enroll about 90 participants.

Study design
This is an interventional study with an estimated enrollment of 90 participants. The phase of the study is not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to approximately 5 years to assess overall response rate and adverse events, and up to approximately 2 years for discontinuing study drugs due to adverse events.

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

NCT06731907

A Study of Pembrolizumab With or Without Chemotherapy in Combination With Additional Treatments for Advanced Non-Small Cell Lung Cancer (NSCLC) (MK-3475-01G/KEYMAKER U01)

Recruiting
PHASE2Ages 18+InterventionalTreatment
Merck Sharp & Dohme LLC
~90 participants
Updated 2026-08-18 on ClinicalTrials.gov
What's tested:PembrolizumabCarboplatinPaclitaxelNab-paclitaxelPemetrexedHER3-DXd

At a glance

Recruiting sites
38 of 41 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall Response Rate (ORR)
Measured over Up to ~ 5 years
+2 more outcomes measured

Conditions

Non-small Cell Lung Cancer

Explore related trials

Lung Non-Small Cell Carcinoma

Where it's being run

41 sites across 28 states
Israel6
Region M. de Santiago3
Taiwan3
Turkey (Türkiye)3
Italy2
Spain2
Kentucky1
Maryland1

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?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

Histologically or cytologically confirmed diagnosis of Stage IV squamous or non-squamous non-small cell lung cancer (NSCLC) per American Joint Committee on Cancer (AJCC) Staging Manual Version 8.
Has an Eastern Cooperative Oncology Group (ECOG) performance status of either 0 or 1 as assessed within 7 days before randomization.
Has archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated has been provided.
Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on 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 prior to treatment randomization.

Exclusion

Has a diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements.
Participants with squamous histology are excluded if there is a known tumor-activating epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) or c ros oncogene 1 (ROS1) gene rearrangement.
Is HIV-infected with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder, or any autoimmune, connective tissue, or inflammatory disorders with pulmonary involvement.
Has evidence of any leptomeningeal disease.
Has known history of, or active, neurologic paraneoplastic syndrome.
Has clinically significant corneal disease.
Has myocardial infarction within 6 months.
Has New York Heart Association (NYHA) Classes 3 or 4 congestive heart failure.
Has uncontrolled angina pectoris within 6 months.
Has cardiac arrhythmia requiring ongoing antiarrhythmic treatment.
Has history of clinically relevant ventricular arrhythmias, such as ventricular tachycardia, ventricular fibrillation, or Torsade de Pointes.
Has bradycardia of less than 50 beats per minute (bpm) unless the participant has a pacemaker.
Has history of second- or third-degree heart block. Candidates with a history of heart block may be eligible if they currently have pacemakers and have no history of fainting or clinically relevant arrhythmia with pacemakers.
Has coronary/peripheral artery bypass graft within 6 months.
Has complete left bundle branch block.
Has inadequate washout period from prior concomitant therapy as specified in protocol before randomization.
Has received prior treatment with a topoisomerase I inhibitor or an anti-HER3 antibody and/or ADC that consists of an exatecan derivative that is a topoisomerase I inhibitor.
Has received prior systemic anticancer therapy for their metastatic NSCLC.
Has received prior therapy with an anti- programmed cell death 1 protein (anti-PD-1), anti- programmed cell death ligand 1 protein (anti-PD-L1), or anti- programmed cell death ligand 2 protein (anti-PD-L2) agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor.
Has received prior radiotherapy within 2 weeks of randomization, has radiation related toxicity requiring corticosteroids, or has had radiation pneumonitis.
Has received radiation therapy to the lung that is \>30 gray within 6 months of start of study intervention.
Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention.
Has known additional malignancy that is progressing or has required active treatment within the past 3 years.
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
Has severe hypersensitivity to any of the study interventions and/or any of their excipients.
Has active autoimmune disease that has required systemic treatment in the past 2 years.
Has active infection requiring systemic therapy.
Has concurrent active Hepatitis B and Hepatitis C virus infection.
Have not adequately recovered from major surgery or have ongoing surgical complications.

What this trial measures

  • Overall Response Rate (ORR)Up to ~ 5 years

    ORR is defined as a confirmed complete response or partial response per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by Blinded Independent Central Review (BICR).

  • Number of Participants with Adverse Events (AEs)Up to ~ 5 years

    Adverse events are any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.

  • Number of Participants Discontinuing Study Drug Due to AEsUp to ~ 2 years

    Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.