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NCT07286149 | RECRUITING | Lung Neoplasm Malignant

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

Merck Sharp & Dohme LLC

Brief Summary:

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

Condition or disease

Lung Neoplasm Malignant

Intervention/treatment

MK-1084

Patritumab deruxtecan

Sacituzumab tirumotecan

Cetuximab

Rescue Medications

Phase

PHASE1

PHASE2

Detailed Description:

This is a substudy of the master protocol MK-3475-U01 (KEYMAKER-U01) - NCT04165798.

Study Type : INTERVENTIONAL
Estimated Enrollment : 190 participants
Masking : NONE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2026-03-23
Estimated Primary Completion Date : 2031-08-11
Estimated Study Completion Date : 2037-05-06

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
A Clinical Study of MK-1084 With Other Treatments for Non-small Cell Lung Cancer (MK-3475-01F)

Location Details

NCT07286149

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Florida

Clermont Oncology Center (Site 0041)

Clermont, florida, United States, 34711