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

Official record

Identifier

NCT06780085

Recruiting locations

countries

United StatesChileGermanyGreeceHungaryIsraelItalyPolandSpainTurkey (Türkiye)

Interventions studied

Raludotatug DeruxtecanIfinatamab DeruxtecanDocetetaxel5-hydroxytryptamine subtype 3 receptor antagonistNeurokinin-1 receptor antagonistCorticosteroid

Lead sponsor

Merck Sharp & Dohme LLC

Target enrolment

96 participants

Study type

INTERVENTIONAL

Phase

Phase 2

Status

Recruiting

First posted

Jan 17, 2025

Last updated on the registry

Oct 1, 2026

Age

18 Years

Sex

ALL

Study contact

The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

* 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 Criteria:

The main exclusion criteria include but are not limited to the following:

* 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

Indexed under

Lung Cancer