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

Recruiting now · Phase 1/Phase 2

Conditions studied: Lung Neoplasm Malignant

In brief

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

Key facts

Study ID

NCT07286149

Run by

Merck Sharp & Dohme LLC

People needed

140

Starts

2026-04-30

Expected to finish

2032-04-13

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.