Purpose

Researchers are looking for new ways to treat locally advanced non-small cell lung cancer (NSCLC) that is unresected and has a gene mutation called KRAS G12C. Researchers want to learn if calderasib (MK-1084) can be given with durvalumab, an immunotherapy, to treat NSCLC after chemotherapy and radiation therapy. The goal of this trial is to learn if participants who receive calderasib and durvalumab live longer without the cancer growing or spreading compared to participants who receive placebo and durvalumab.

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 a histological or cytological diagnosis of locally advanced, unresected Stage II (node-positive) to III non-small cell lung cancer (NSCLC) with predominantly nonsquamous histology. - Has completed definitive platinum-based concurrent chemoradiotherapy (CCRT) prior to enrollment, without disease progression. - Has provided a tumor tissue sample for central laboratory testing of Kirsten rat sarcoma G12C (KRAS G12C) status, programmed cell death ligand 1 (PD-L1) status, and biomarker research. - Tumor tissue sample has a demonstrated presence of KRAS G12C mutation and an evaluable PD-L1 status result. - If human immunodeficiency virus (HIV)-infected, has well-controlled HIV on antiretroviral therapy (ART). - If hepatitis B surface antigen (HBsAg)-positive, has undetectable hepatitis B virus (HBV) viral load and has received HBV antiviral therapy. - If has a history of hepatitis C virus (HCV) infection, has undetectable HCV viral load. - Has a body weight ≥35 kg.

Exclusion Criteria

The main exclusion criteria include but are not limited to the following: - Has a diagnosis of small cell lung cancer or mixed tumors with small cell elements. - Has a gastrointestinal disorder affecting absorption or is unable to swallow orally administered medication. - Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease. - Has uncontrolled, significant cardiovascular disease or cerebrovascular disease. - Is HIV-infected with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease. - Has received prior treatment (other than definitive CCRT) for NSCLC. - Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. - Has an active autoimmune disease that has required systemic treatment in the past 2 years. - Has a history of, or has current, (noninfectious) pneumonitis/interstitial lung disease that required/requires steroids. - Has an active infection requiring systemic therapy. - Has a 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
Triple (Participant, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Calderasib + Durvalumab
Participants will receive calderasib and durvalumab.
  • Drug: Calderasib
    Tablet for oral administration.
    Other names:
    • MK-1084
  • Biological: Durvalumab
    Solution for intravenous (IV) infusion.
    Other names:
    • IMFINZI®
Active Comparator
Placebo + Durvalumab
Participants will receive placebo to calderasib and durvalumab.
  • Biological: Durvalumab
    Solution for intravenous (IV) infusion.
    Other names:
    • IMFINZI®
  • Other: Placebo to MK-1084
    Placebo to MK-1084.

Recruiting Locations

NHO Revive Research Institute LLC ( Site 0118)
Lincoln, Nebraska 68506
Contact:
Study Coordinator
402-484-4900

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.