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A Study of New Treatments for Advanced Non-Small Cell Lung Cancer

This study is looking for new ways to treat stage IV (meaning it has spread) nonsquamous non-small cell lung cancer (NSCLC) that has already been treated with other therapies, including immunotherapy. Researchers are testing two investigational drugs, Raludotatug Deruxtecan and Ifinatamab Deruxtecan, given by IV infusion. You may be eligible if you have stage IV nonsquamous NSCLC that has progressed after prior anti-PD-1/PD-L1 treatment and platinum-based chemotherapy. The study will measure how many participants respond to the treatment (Objective Response Rate) and track any side effects. About 96 people are expected to join this study.

Study design
This interventional study plans to enroll 96 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 81 months to assess treatment response and adverse events, and up to 24 months for discontinuation 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.

NCT06780085

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Merck Sharp & Dohme LLC
~96 participants
Updated 2026-08-25 on ClinicalTrials.gov
What's tested:Raludotatug DeruxtecanIfinatamab DeruxtecanDocetetaxel5-hydroxytryptamine subtype 3 receptor antagonistNeurokinin-1 receptor antagonistCorticosteroid

At a glance

Recruiting sites
33 of 34 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Objective Response Rate (ORR)
Measured over Up to approximately 81 months
+2 more outcomes measured

Conditions

Carcinoma, Non-Small-Cell Lung

Explore related trials

Lung Non-Small Cell Carcinoma

Where it's being run

34 sites across 21 states
Israel6
Turkey (Türkiye)5
Region M. de Santiago3
Italy3
Kentucky1
Maryland1
Pennsylvania1
Baden-Wurttemberg1

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

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 adequate organ function
If capable of producing sperm refrains from donating sperm plus either abstains from penile-vaginal intercourse or uses a penile/external condom, with contraceptive use consistent with local regulations
Participant/participants of childbearing potential (POCBP) is not pregnant and has a negative highly sensitive pregnancy test; and is not breastfeeding and uses a highly effective contraceptive method
Archival tumor tissue sample of a tumor lesion not previously irradiated has been provided
Has provided tissue prior to treatment randomization from a newly obtained formalin-fixed sample from a new biopsy
Human Immunodeficiency Virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
Participants who are hepatitis B surface antigen (HBsAg) positive have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization
Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening

Exclusion

Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements
Received radiation therapy to the lung
Has uncontrolled or significant cardiovascular disorder prior to randomization
Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses
Participants who have adverse events (AEs) (other than alopecia) due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline
Has known severe hypersensitivity (≥Grade 3) to study intervention and/or any of its excipients
Has clinically significant corneal disease
Has received prior radiotherapy within 2 weeks of start of study intervention, or radiation related toxicities, requiring corticosteroids
Has inadequate washout period prior to randomization
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
Has previously received docetaxel as monotherapy or in combination with other therapies
Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
Has known additional malignancy that is progressing or has required active treatment within the past 3 years
Has known untreated central nervous system (CNS) metastases and/or carcinomatous meningitis
Has evidence of any leptomeningeal disease
Has history of interstitial lung disease (ILD)/pneumonitis, current diagnosis of ILD, and/or suspected ILD
Has active autoimmune disease that has required systemic treatment in the past 2 years
Has active infection requiring systemic therapy
HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease
Has known history of, or active, neurologic paraneoplastic syndrome
Has history of allogeneic tissue/solid organ transplant
Have not adequately recovered from major surgery or have ongoing surgical complications

What this trial measures

  • Objective Response Rate (ORR)Up to approximately 81 months

    ORR is defined as the percentage of participants with Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.

  • Percentage of Participants with at Least One Adverse Event (AE)Up to approximately 81 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 percentage of participants who experience an AE will be reported.

  • Percentage of Participants Who Discontinued Medication Due to an AEUp 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 percentage of participants who discontinue study intervention due to an AE will be reported.