A Clinical Study of MK-1084 With Other Treatments for Non-small Cell Lung Cancer (MK-3475-01F)
Recruiting · NCT07286149 · Interventional (participants receive a specific treatment) · Lead sponsor: Merck Sharp & Dohme LLC
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
28 locations listed across 3 US states.
- 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 Clinic de Barcelona ( Site 0092) - Barcelona, Spain
- Queen Mary Hospital ( Site 0230) - Hong Kong, Hong Kong
- Shaare Zedek Medical Center ( Site 0186) - Jerusalem, Israel
- Hong Kong United Oncology Centre ( Site 0232) - Jordan, Hong Kong
- Meir Medical Center ( Site 0181) - Kfar Saba, Israel
- Sheba Medical Center ( Site 0180) - Ramat Gan, Israel
- Severance Hospital, Yonsei University Health System ( Site 0080) - Seoul, South Korea
- Hospital Universitario Virgen Macarena ( Site 0093) - Seville, Spain
- Prince of Wales Hospital ( Site 0231) - Shatin, Hong Kong
- THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA" ( Site 0204) - Athens, Attica, Greece
- Alexandra General Hospital of Athens-ONCOLOGY DEPT. ( Site 0205) - Athens, Attica, Greece
- UniversitaetsklInikum Tuebingen ( Site 0192) - Tübingen, Baden-Wurttemberg, Germany
- Institut Català d'Oncologia - L'Hospitalet ( Site 0090) - Hospitalet, Barcelona, Spain
- IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" ( Site 0176) - Meldola, Forli-Cesena, Italy
- Guangdong Provincial People s Hospital ( Site 0300) - Guangzhou, Guangdong, China
- HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 0091) - Pozuelo de Alarcón, Madrid, Spain
- Centro de Estudios Clínicos SAGA-CECSAGA ( Site 0162) - Santiago, Region M. de Santiago, Chile
- FALP ( Site 0161) - Santiago, Region M. de Santiago, Chile
- Bradfordhill ( Site 0160) - Santiago, Region M. de Santiago, Chile
- 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
- Papageorgiou General Hospital of Thessaloniki ( Site 0206) - N.Efkarpia, Thessaloniki, Greece