MK-1084 combined with other therapies for advanced non-squamous non-small cell lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This substudy of the KEYMAKER-U01 master protocol (MK-3475-U01) is a Phase 1/2 interventional program that gives MK-1084 together with one or more partner agents (including antibody-drug conjugates and monoclonal antibodies) to determine safety, tolerability, and anti-tumor activity. Participants must have advanced or metastatic non-squamous NSCLC with a confirmed KRAS G12C mutation by tumor tissue or ctDNA and have progressed after 1–2 prior lines of platinum-based chemotherapy and PD-(L)1 therapy. The study requires provision of archival and newly obtained tumor biopsies (from lesions not previously irradiated) and includes rescue medication guidelines as needed. Primary endpoints focus on dose-limiting toxicities and objective response rates, with additional monitoring of adverse events and pharmacodynamics.

Why it matters

Who can join: the full rules

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's running

• Clermont Oncology Center ( Site 0041)
  Clermont, Florida, United States Recruiting
• University of Illinois Hospital & Health Sciences System ( Site 0044)
  Chicago, Illinois, United States Recruiting
• Providence Portland Medical Center ( Site 0043)
  Portland, Oregon, United States Recruiting
• Providence Oncology and Hematology Care Clinic - Westside ( Site 0059)
  Portland, Oregon, United States Recruiting
• Hospital São Lucas da PUCRS ( Site 0283)
  Porto Alegre, Rio Grande do Sul, Brazil Recruiting
• Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0282)
  Barretos, São Paulo, Brazil Recruiting

Study contacts

• Study coordinator: Toll Free Number
• Email: Trialsites@msd.com
• Phone: 1-888-577-8839

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.