Purpose

Researchers want to learn if the study medicines MK-1084 and subcutaneous (SC) pembrolizumab can be used to treat non-small cell lung cancer (NSCLC) when given together. MK-1084 is a targeted therapy for the KRAS G12C mutation. The goal of this study is to learn if people who receive MK-1084 with SC pembrolizumab live longer without the cancer growing or spreading than in people who receive SC pembrolizumab with chemotherapy.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

The main inclusion criteria include but are not limited to the following: - Has nonsquamous NSCLC (Stage IIIB, Stage IIIC) not eligible for curative resection or chemoradiation or Stage IV: M1a, M1b, or M1c - If human immunodeficiency virus (HIV) positive, must have well controlled HIV on antiretroviral therapy (ART)

Exclusion Criteria

The main exclusion criteria include but are not limited to the following: - Has diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements - Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, or chronic diarrhea) - Has uncontrolled, significant cardiovascular disease or cerebrovascular disease - Has a gastrointestinal disorder affecting absorption - Is HIV positive and has a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease - Has received prior systemic anticancer therapy for their advanced or metastatic NSCLC - Has known additional malignancy that is progressing or has required active treatment within the past 3 years - Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis - Has active autoimmune disease that has required systemic treatment in the past 2 years - History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease - Has active infection requiring systemic therapy except those specified by protocol - Has history of stem cell/solid organ transplant - Has not adequately recovered from major surgery or has ongoing surgical complications

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
MK-1084 + Pembrolizumab (+) Berahyaluronidase alfa
Participants will receive pembrolizumab (+) berahyaluronidase alfa at a fixed dose subcutaneously on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) plus MK-1084 until discontinuation criterion is met.
  • Drug: MK-1084
    Administered as an oral tablet
  • Biological: Pembrolizumab (+) Berahyaluronidase alfa
    Administered as a SC injection
    Other names:
    • MK-3475A
Active Comparator
Pembrolizumab (+) Berahyaluronidase alfa + Chemotherapy
Participants will receive pembrolizumab (+) berahyaluronidase alfa at a fixed dose subcutaneously on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) and pemetrexed via intravenous (IV) infusion at a dose of 500 mg/m^2 on days 1 and 22 of cycles 1 and 3 until discontinuation criterion is met PLUS investigator's choice of carboplatin via IV infusion at area under curve (AUC) 5 mg/mL/minute on days 1 and 22 of cycles 1 and 3 (up to 4 doses, approximately 6 weeks) OR cisplatin via IV infusion at a dose of 75 mg/m^2 on days 1 and 22 of cycles 1 and 3 (up to 4 doses, approximately 6 weeks).
  • Biological: Pembrolizumab (+) Berahyaluronidase alfa
    Administered as a SC injection
    Other names:
    • MK-3475A
  • Drug: Pemetrexed
    Administered as an IV Infusion
    Other names:
    • Alimta
  • Drug: Cisplatin
    Administered as an IV Infusion
    Other names:
    • Platinol-AQ
  • Drug: Carboplatin
    Administered as an IV Infusion
    Other names:
    • PARAPLATIN®

Recruiting Locations

Mount Sinai Cancer Center ( Site 0137)
Miami Beach 4164143, Florida 4155751 33140
Contact:
Study Coordinator
305-674-2625

New England Cancer Specialists ( Site 0139)
Westbrook 4982753, Maine 4971068 04092
Contact:
Study Coordinator
207-303-3300

New York Oncology Hematology, P.C. ( Site 0119)
Albany 5106834, New York 5128638 12206
Contact:
Study Coordinator
518-489-3612

More Details

Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

Toll Free Number
1-888-577-8839
Trialsites@msd.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.