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RecruitingPhase 1 / Phase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests MK-1084 with other treatments for advanced or spreading non-squamous non-small cell lung cancer with a KRAS G12C gene change. MK-1084 targets how certain cancer cells grow and spread. Researchers will check its safety, how well people handle treatment, and whether tumors shrink or go away.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have non-squamous non-small cell lung cancer that is advanced or has spread, confirmed by a tissue or cell test.
  • Have a KRAS G12C gene change found in tumor tissue or cancer DNA in the blood.
  • Have cancer that got worse after 1–2 rounds of treatment plans that included PD-1/PD-L1 immune therapy and platinum-based chemotherapy.
  • Provide a stored or new tumor tissue sample for testing. The sample must come from a tumor area not treated with radiation.
  • If you have HIV, it must be well controlled with HIV medicines under the study rules.

Who can't join

  • Have small cell lung cancer, including a tumor with both small cell and other cancer cells.
  • Have severe breathing problems from another lung illness, or current, past, or suspected inflammation or scarring of the lungs.
  • Have active cancer spread to the brain or spinal cord, or any cancer in the tissues covering them.
  • Have current or past inflammatory bowel disease, which causes swelling in the digestive tract; or serious or uncontrolled heart, blood vessel, or brain blood vessel disease.
  • Have serious disease of the clear front of the eye, or a history of severe dry eyes, eyelid oil gland disease, or eyelid inflammation.
  • Have HIV with a history of Kaposi’s sarcoma or multicentric Castleman disease; a weakened immune system; or ongoing steroid or other immune-suppressing treatment within 7 days before study treatment.
  • Received a live vaccine within 30 days before study treatment, or have an active infection needing medicine that works throughout the body.
  • Have another cancer that is growing or needed treatment in the past 3 years, or have not healed enough from major surgery or still have surgery-related problems.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (4)

FL

IL

OR