Combining MK-1084 and Pembrolizumab for Advanced Lung Cancer with Specific Genetic Mutations

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 study evaluates the effectiveness and safety of MK-1084 in combination with pembrolizumab as a first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC) who have the KRAS G12C mutation and a PD-L1 tumor proportion score of 50% or higher. The trial tests two main hypotheses: that the combination treatment improves progression-free survival and overall survival compared to a placebo plus pembrolizumab. Participants will be monitored for their response to treatment using established criteria for solid tumors.

Why it matters

Who can join: the full rules

The main inclusion and exclusion criteria include but are not limited to the following:

Inclusion Criteria:

* Has histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC)
* Has newly diagnosed Stage IIIB/IIIC NSCLC, not eligible for curative resection or curative chemotherapy/radiation as determined by a multidisciplinary tumor board and/or by radiation oncologist, surgeon, and medical oncologist or Stage IV (M1a, M1b, or M1c) by American Joint Committee on Cancer (AJCC) Staging Manual, Version 8
* Provides an archival tumor sample (≤5 years) or newly obtained core, incisional, or excisional biopsy or fine needle aspirate (FNA) of a tumor lesion, not previously irradiated to enable central laboratory testing of kirsten rat sarcoma (KRAS) G12C mutation status, programmed cell death ligand 1 (PD-L1) status, and biomarker research
* If have had adverse events (AEs) due to previous anticancer therapies, must have recovered to \< Grade 1 or baseline
* If human immunodeficiency virus (HIV)-infected, must have well controlled HIV on antiretroviral therapy (ART)
* If Hepatitis B surface antigen (HBsAg) positive, have received Hepatitis B Virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load
* If a participant has a history of Hepatitis C virus (HCV) infection, HCV viral load is undetectable

Exclusion Criteria:

* Has diagnosis of small cell lung cancer. For mixed tumors, if small cell elements are present, the participant is ineligible
* Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease
* Has known history of, or active, neurologic paraneoplastic syndrome
* Has an active infection requiring systemic therapy, with exceptions
* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
* Has received prior systemic anticancer therapy for their locally advanced or metastatic NSCLC
* Has received radiation therapy to the lung that is \>30 Gray within 6 months of start of study intervention
* Has received radiotherapy to non-central nervous system (CNS) disease within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not required corticosteroids, and not have had radiation pneumonitis
* Has known active CNS metastases and/or carcinomatous meningitis
* Known additional malignancy that is progressing or has required active treatment within the past 3 years
* Has active autoimmune disease that has required systemic treatment in the past 2 years
* Has history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
* Is HIV-infected and has a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
* Has history of allogenic tissue/solid organ transplant
* Has not fully recovered from any effects of major surgical procedure

Where it's running

• CBCC Global Research, Inc. ( Site 0123)
  Bakersfield, California, United States Recruiting
• Beverly Hills Cancer Center ( Site 0116)
  Beverly Hills, California, United States Recruiting
• Stamford Hospital ( Site 0136)
  Stamford, Connecticut, United States Recruiting
• Orchard Healthcare Research Inc. ( Site 0115)
  Skokie, Illinois, United States Recruiting
• Truman Medical Center ( Site 0126)
  Kansas City, Missouri, United States Recruiting
• Cox Medical Center North ( Site 0133)
  Springfield, Missouri, United States Recruiting

+197 more sites. See ClinicalTrials.gov for the full list.

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.