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

NCT07286149 · Merck Sharp & Dohme LLC
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Official title
KEYMAKER-U01 Substudy 01F: A Phase 1b/2 Umbrella Study With Rolling Arms of Investigational Agents for Previously Treated Participants With Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With KRAS G12C Mutations
About this study
This is a substudy of the master protocol MK-3475-U01 (KEYMAKER-U01) - NCT04165798.
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 * Provides archival tumor tissue sample of a tumor lesion not previously irradiated * Has provided tissue prior to treatment allocation/randomization from a newly obtained 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 previous treatment with an agent targeting KRAS * 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 history of (noninfectious) pneumonitis/ interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD * Has an active infection requiring systemic therapy * Have not adequately recovered from major surgery or have ongoing surgical complications
Study design
Enrollment target: 190 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-04-30
Estimated completion: 2032-04-13
Last updated: 2026-06-18
Interventions
Drug: MK-1084Biological: Patritumab deruxtecanBiological: Sacituzumab tirumotecanBiological: CetuximabDrug: Rescue Medications
Primary outcomes
  • Number of Participants Who Experience a Dose Limiting Toxicity (DLT) (Up to 42 days)
  • Number of Participants Who Experience an Adverse Event (AE) (Up to approximately 65 months)
  • Number of Participants Who Discontinue Study Treatment Due to an AE (Up to approximately 64 months)
Sponsor
Merck Sharp & Dohme LLC · industry
With: Daiichi Sankyo
Contacts & investigators
ContactToll Free Toll Free Number · contact · Trialsites@msd.com · 1-888-577-8839
InvestigatorMedical Director · study_director, Merck Sharp & Dohme LLC
All locations (24)
Clermont Oncology Center ( Site 0041)Recruiting
Clermont, Florida, United States
University of Illinois Hospital & Health Sciences System ( Site 0044)Recruiting
Chicago, Illinois, United States
Providence Portland Medical Center ( Site 0043)Recruiting
Portland, Oregon, United States
Providence Oncology and Hematology Care Clinic - Westside ( Site 0059)Recruiting
Portland, Oregon, United States
Hospital São Lucas da PUCRS ( Site 0283)Recruiting
Porto Alegre, Rio Grande do Sul, Brazil
Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0282)Recruiting
Barretos, São Paulo, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0286)Recruiting
São José do Rio Preto, São Paulo, Brazil
Hospital Paulistano ( Site 0280)Recruiting
São Paulo, São Paulo, Brazil
Centro de Estudios Clínicos SAGA-CECSAGA ( Site 0162)Recruiting
Santiago, Region M. de Santiago, Chile
FALP ( Site 0161)Recruiting
Santiago, Region M. de Santiago, Chile
Bradfordhill ( Site 0160)Recruiting
Santiago, Region M. de Santiago, Chile
Guangdong Provincial People s Hospital ( Site 0300)Recruiting
Guangzhou, Guangdong, China
THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA" ( Site 0204)Recruiting
Athens, Attica, Greece
Alexandra General Hospital of Athens-ONCOLOGY DEPT. ( Site 0205)Recruiting
Athens, Attica, Greece
Queen Mary Hospital ( Site 0230)Recruiting
Hong Kong, Hong Kong
Hong Kong United Oncology Centre ( Site 0232)Recruiting
Jordan, Hong Kong
Prince of Wales Hospital ( Site 0231)Recruiting
Shatin, Hong Kong
Shaare Zedek Medical Center ( Site 0186)Recruiting
Jerusalem, Israel
Sheba Medical Center ( Site 0180)Recruiting
Ramat Gan, Israel
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" ( Site 0176)Recruiting
Meldola, Forli-Cesena, Italy
Severance Hospital, Yonsei University Health System ( Site 0080)Recruiting
Seoul, South Korea
Institut Català d'Oncologia - L'Hospitalet ( Site 0090)Recruiting
Hospitalet, Barcelona, Spain
Hospital Clinic de Barcelona ( Site 0092)Recruiting
Barcelona, Spain
Hospital Universitario Virgen Macarena ( Site 0093)Recruiting
Seville, Spain
A Clinical Study of MK-1084 With Other Treatments for Non-small Cell Lung Cancer (MK-3475-01F) · TrialPath