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RecruitingInterventionalPhase 3

A Phase 3, Randomized, Double-blind, Placebo- and Active-Comparator-Controlled Study of MK-1084 Plus Durvalumab Versus Placebo Plus Durvalumab in Participants With Locally Advanced, Unresected KRAS G12C-Mutant Non-Small Cell Lung Cancer Without Disease Progression Following Definitive Platinum-Based Chemoradiotherapy (KANDLELIT-015)

NCT ID: NCT07554339Sponsor: Merck Sharp & Dohme LLCLast updated: 2026-06-03

Summary

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.

Arms & interventions

  • DrugCalderasib

    Tablet for oral administration.

  • BiologicalDurvalumab

    Solution for intravenous (IV) infusion.

  • OtherPlacebo to MK-1084

    Placebo to MK-1084.

Outcome measures

Primary

  • Progression-Free Survival (PFS)

    PFS is defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first.

    Time frame: Up to approximately 6 years

Secondary

  • Overall Survival (OS)

    Time frame: Up to approximately 9 years

  • Number of Participants Who Experience an Adverse Events (AEs)

    Time frame: Up to approximately 9 years

  • Number of Participants Who Discontinue Study Treatment Due to an AE

    Time frame: Up to approximately 9 years

  • Objective Response Rate (ORR)

    Time frame: Up to approximately 9 years

  • Duration of Response (DOR)

    Time frame: Up to approximately 9 years

  • Distant Metastasis-Free Survival (DMFS)

    Time frame: Up to approximately 9 years

  • Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (GHS)/Quality of Life (QoL) (Items 29 & 30) Combined Score

    Time frame: Baseline and up to approximately 9 years

  • Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score

    Time frame: Baseline and up to approximately 9 years

  • Change from Baseline in Role Functioning (EORTC QLQ-C30 Items 6 & 7) Combined Score

    Time frame: Baseline and up to approximately 9 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy 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 locations (1)

NHO Revive Research Institute LLC ( Site 0118)

Lincoln, Nebraska, 68506

Recruiting
Study Coordinator · Contact