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RECRUITING Phase 1 / Phase 2 ClinicalTrials.gov

A Clinical Study of MK-1084 With Other Treatments for Non-small Cell Lung Cancer (MK-3475-01F)

Sponsor: Merck Sharp & Dohme LLC • ClinicalTrials.gov ID: NCT07286149

Registry updated: 2026-10-01
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Description

Researchers want to learn if MK-1084, the study medicine, can treat advanced or metastatic non-squamous NSCLC. MK-1084 is a targeted therapy, which is a treatment that works to control how specific types of cancer cells grow and spread. The goals of this study are to learn: * About the safety of MK-1084 and if people tolerate it when taken with other treatments * How many people have the cancer respond (get smaller or go away) to the treatments

Interventions

  • MK-1084 (Drug)
    Oral administration
  • Patritumab deruxtecan (Biological)
    IV infusion
  • Sacituzumab tirumotecan (Biological)
    IV Infusion
  • Cetuximab (Biological)
    IV Infusion
  • Rescue Medications (Drug)
    Participants receive rescue medication at the investigator's discretion for prevention of nausea and vomiting, per approved product label. Recommended rescue medications are histamine-1 (H1) receptor antagonist, histamine-2 (H2) receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent infusion, or steroid mouthwash (dexamethasone or equivalent), 5-hydroxytryptamine type 3 (5-HT3) receptor antagonist, neurokinin 1 (NK-1) receptor antagonist and corticosteroid.

Eligibility criteria

Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Has histologically or cytologically confirmed diagnosis of advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) * Has tumor tissue or circulating tumor deoxyribonucleic acid (ctDNA) that demonstrates the presence of Kirsten rat sarcoma viral oncogene (KRAS) mutation of glycine to cysteine at codon 12 (G12C) mutations * Has documented disease progression after receiving 1-2 prior lines of programmed cell death protein 1 (PD-1)/programmed death-ligand 1 (PD-L1) therapy and platinum-based chemotherapy * Has provided tumor tissue for biomarker analysis from an archival sample or a newly obtained core or excisional biopsy of a tumor lesion not previously irradiated * Participants with human immunodeficiency virus (HIV) infection must have well-controlled HIV on antiretroviral therapy (ART) per protocol Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has a diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements * Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses * Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis * Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease * Has evidence of any leptomeningeal disease * Has uncontrolled or significant cardiovascular disorder or cerebrovascular disease prior to allocation/randomization * Has one or more of the following ophthalmological conditions: a) Clinically significant corneal disease b) history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis * HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease * Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention * Has a 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 any history of interstitial lung disease (ILD)/pneumonitis irrespective of steroid use or current ILD, or suspected ILD * Has an active infection requiring systemic therapy * Has not adequately recovered from major surgery or has ongoing surgical complications

Conditions

Lung Neoplasm Malignant

Locations

  • Clermont Oncology Center ( Site 0041) — Clermont, Florida, United States
  • University of Illinois Hospital & Health Sciences System ( Site 0044) — Chicago, Illinois, United States
  • Providence Portland Medical Center ( Site 0043) — Portland, Oregon, United States
  • Providence Oncology and Hematology Care Clinic - Westside ( Site 0059) — Portland, Oregon, United States
  • Hospital São Lucas da PUCRS ( Site 0283) — Porto Alegre, Rio Grande do Sul, Brazil
  • Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0282) — Barretos, São Paulo, Brazil
  • Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0286) — São José do Rio Preto, São Paulo, Brazil
  • Hospital Paulistano ( Site 0280) — São Paulo, São Paulo, Brazil
  • Centro de Estudios Clínicos SAGA-CECSAGA ( Site 0162) — Santiago, Region M. de Santiago, Chile
  • Fundación Arturo López Pérez ( Site 0161) — Santiago, Region M. de Santiago, Chile
  • Bradfordhill ( Site 0160) — Santiago, Region M. de Santiago, Chile
  • Guangdong Provincial People s Hospital ( Site 0300) — Guangzhou, Guangdong, China
  • Yunnan Province Cancer Hospital ( Site 0302) — Kunming, Yunnan, China
  • UniversitaetsklInikum Tuebingen ( Site 0192) — Tübingen, Baden-Wurttemberg, Germany
  • THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA" ( Site 0204) — Athens, Attica, Greece
  • Alexandra General Hospital of Athens-ONCOLOGY DEPT. ( Site 0205) — Athens, Attica, Greece
  • Papageorgiou General Hospital of Thessaloniki ( Site 0206) — N.Efkarpia, Thessaloniki, Greece
  • Queen Mary Hospital ( Site 0230) — Hong Kong, Hong Kong
  • Hong Kong United Oncology Centre ( Site 0232) — Jordan, Hong Kong
  • Prince of Wales Hospital ( Site 0231) — Shatin, Hong Kong
  • Shaare Zedek Medical Center ( Site 0186) — Jerusalem, Israel
  • Meir Medical Center ( Site 0181) — Kfar Saba, Israel
  • Sheba Medical Center ( Site 0180) — Ramat Gan, Israel
  • IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" ( Site 0176) — Meldola, Forli-Cesena, Italy
  • Severance Hospital, Yonsei University Health System ( Site 0080) — Seoul, South Korea
  • Institut Català d'Oncologia - L'Hospitalet ( Site 0090) — Hospitalet, Barcelona, Spain
  • HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 0091) — Pozuelo de Alarcón, Madrid, Spain
  • Hospital Clinic de Barcelona ( Site 0092) — Barcelona, Spain
  • Hospital Universitario Virgen Macarena ( Site 0093) — Seville, Spain
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record