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

Sponsor: Merck Sharp & Dohme LLC

Sponsor score: 40

ClinicalTrials ID:NCT07286149

This substudy of MK-3475-U01 investigates MK-1084's safety and efficacy in advanced/metastatic non-squamous NSCLC with KRAS G12C mutation. Eligible participants must have progressed after PD-1/PD-L1 and platinum-based therapies. Interventions include MK-1084 (oral) and biologicals like patritumab deruxtecan, sacituzumab tirumotecan, and cetuximab (IV infusions). Rescue medications are provided as needed.

Patient Parameters

Program Overview

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

Description

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

Locations

FACILITYZIPCITYSTATE
Clermont Oncology Center ( Site 0041)34711ClermontFlorida
University of Illinois Hospital & Health Sciences System ( Site 0044)60612ChicagoIllinois

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