RECRUITING

A Study of MK-1084 Plus Pembrolizumab (MK-3475) in Participants With KRAS G12C Mutant Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-1084-004/KANDLELIT-004)

Description

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).

Study Overview

Study Details

Study overview

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).

A Phase 3, Randomized, Double-blind, Multicenter Study of MK-1084 in Combination With Pembrolizumab Compared With Pembrolizumab Plus Placebo as Firstline Treatment of Participants With KRAS G12C-Mutant, Locally Advanced or Metastatic NSCLC With PD-L1 TPS ≥50% (KANDLELIT-004)

A Study of MK-1084 Plus Pembrolizumab (MK-3475) in Participants With KRAS G12C Mutant Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-1084-004/KANDLELIT-004)

Condition
Non-small Cell Lung Cancer
Intervention / Treatment

-

Contacts and Locations

Bakersfield

CBCC Global Research, Inc. ( Site 0123), Bakersfield, California, United States, 93309

Beverly Hills

Beverly Hills Cancer Center ( Site 0116), Beverly Hills, California, United States, 90211

Miami Beach

Mount Sinai Cancer Center ( Site 0137), Miami Beach, Florida, United States, 33140

Skokie

Orchard Healthcare Research Inc. ( Site 0115), Skokie, Illinois, United States, 60077

Kansas City

Truman Medical Center ( Site 0126), Kansas City, Missouri, United States, 64108

Springfield

Cox Medical Center North ( Site 0133), Springfield, Missouri, United States, 65807

Billings

St. Vincent Frontier Cancer Center-Research ( Site 0105), Billings, Montana, United States, 59102

Morristown

Atlantic Health System Morristown Medical Center ( Site 0121), Morristown, New Jersey, United States, 07960

Albany

New York Oncology Hematology, P.C. ( Site 0132), Albany, New York, United States, 12206

Cincinnati

University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 0103), Cincinnati, Ohio, United States, 45219

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Merck Sharp & Dohme LLC,

Medical Director, STUDY_DIRECTOR, Merck Sharp & Dohme LLC

Study Record Dates

2031-02-18