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

RecruitingPhase 1, Phase 2

Sponsor: Merck Sharp & Dohme LLC

Conditions: Lung Neoplasm Malignant

Interventions: MK-1084, Patritumab deruxtecan, Sacituzumab tirumotecan, Cetuximab, Rescue Medications

Countries: United States, Brazil, Chile, China, Germany, Greece, Hong Kong, Israel

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

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (25)

Clermont, Florida, United States
Chicago, Illinois, United States
Portland, Oregon, United States
Portland, Oregon, United States
Porto Alegre, Rio Grande do Sul, Brazil
Barretos, São Paulo, Brazil
São José do Rio Preto, São Paulo, Brazil
São Paulo, São Paulo, Brazil
Santiago, Region M. de Santiago, Chile
Santiago, Region M. de Santiago, Chile
Santiago, Region M. de Santiago, Chile
Guangzhou, Guangdong, China
Tübingen, Baden-Wurttemberg, Germany
Athens, Attica, Greece
Athens, Attica, Greece
Hong Kong, Hong Kong
Jordan, Hong Kong
Shatin, Hong Kong
Jerusalem, Israel
Ramat Gan, Israel
Meldola, Forli-Cesena, Italy
Seoul, South Korea
Hospitalet, Barcelona, Spain
Barcelona, Spain
Seville, Spain