Print

Purpose

This is a study evaluating the efficacy and safety of MK-1084 with pembrolizumab as first-line treatment in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) with identified Kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation and programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥50%. There are two primary study hypotheses: Hypothesis 1: Combination of MK-1084 and pembrolizumab is superior to placebo plus pembrolizumab with respect to progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR). Hypothesis 2: Combination of MK-1084 plus pembrolizumab is superior to placebo plus pembrolizumab with respect to overall survival (OS).

Condition

Eligibility

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

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 tissue sample (≤5 years) or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated to enable central laboratory testing of kirsten rat sarcoma (KRAS) G12C mutation status, 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 one or more of the following ophthalmological findings/conditions: intraocular pressure >21 mmHg and/or any diagnosis of glaucoma, diagnosis of central serous retinopathy, retinal vein occlusion, or retinal artery occlusion, diagnosis of retinal degenerative 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 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 central nervous system 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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
MK-1084 with Pembrolizumab 		Participants receive pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles and MK-1084 by oral tablets until discontinuation criterion is met.
  • Drug: MK-1084
    Oral tablets
  • Biological: Pembrolizumab
    IV infusion
    Other names:
    • MK-3475
    • KEYTRUDA ®
Active Comparator
Placebo with Pembrolizumab 		Participants receive pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles and placebo by oral tablets once daily until discontinuation criterion is met.
  • Other: Placebo
    Oral tablets
  • Biological: Pembrolizumab
    IV infusion
    Other names:
    • MK-3475
    • KEYTRUDA ®

Recruiting Locations

CBCC Global Research, Inc. ( Site 0123)
Bakersfield 5325738, California 5332921 93309
Contact:
Study Coordinator
888-577-8839

Beverly Hills Cancer Center ( Site 0116)
Beverly Hills 5328041, California 5332921 90211
Contact:
Study Coordinator
310-432-8955

Mount Sinai Cancer Center ( Site 0137)
Miami Beach 4164143, Florida 4155751 33140
Contact:
Study Coordinator
888-577-8839

Orchard Healthcare Research Inc. ( Site 0115)
Skokie 4911600, Illinois 4896861 60077
Contact:
Study Coordinator
224-534-7580

Truman Medical Center ( Site 0126)
Kansas City 4393217, Missouri 4398678 64108
Contact:
Study Coordinator
816-404-4093

Cox Medical Center North ( Site 0133)
Springfield 4409896, Missouri 4398678 65807
Contact:
Study Coordinator
417-875-3000

St. Vincent Frontier Cancer Center-Research ( Site 0105)
Billings 5640350, Montana 5667009 59102
Contact:
Study Coordinator
888-577-8839

Atlantic Health System Morristown Medical Center ( Site 0121)
Morristown 5101427, New Jersey 5101760 07960
Contact:
Study Coordinator
973-275-7788

New York Oncology Hematology, P.C. ( Site 0132)
Albany 5106834, New York 5128638 12206
Contact:
Study Coordinator
888-577-8839

University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 0103)
Cincinnati 4508722, Ohio 5165418 45219
Contact:
Study Coordinator
888-577-8839

Kettering Health Main Campus-Kettering Health Cancer Center ( Site 0106)
Kettering 4515843, Ohio 5165418 45429
Contact:
Study Coordinator
888-577-8839

Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0134)
Lancaster 5197079, Pennsylvania 6254927 17601
Contact:
Study Coordinator
717-544-9400

Oncology Consultants P.A. ( Site 0113)
Houston 4699066, Texas 4736286 77030
Contact:
Study Coordinator
713-600-0900

Circuit Clinical/SSM Health Dean Medical Group ( Site 0129)
Madison 5261457, Wisconsin 5279468 53715
Contact:
Study Coordinator
888-577-8839

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.