A Clinical Trial of Calderasib (MK-1084) and Durvalumab in People With Non-Small Cell Lung Cancer (MK-1084-015/KANDLELIT-015)

ClinicalTrials.gov ID

NCT07554339

Lead Sponsor

Merck Sharp & Dohme LLCINDUSTRY

Overall Status

Recruiting

Study Type

Interventional

Phase

Phase 3

Enrollment

310Estimated

Last Update Posted

Sep 9, 2026Actual

Start Date

Jun 18, 2026Actual

Primary Completion Date

Dec 15, 2032Estimated

Completion Date

Aug 17, 2037Estimated

Official Title

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)

Brief 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.

• Non-small Cell Lung Cancer

• Calderasib
• Durvalumab
• Placebo to MK-1084

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Triple

Lead Sponsor

Merck Sharp & Dohme LLCINDUSTRY

+862787670275

+82230103214

+34913303000x484835

+34917277516

+886-2543-3535

+886287923311

• A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

  NCT07190248

  RecruitingInterventionalPhase 3Updated Sep 9, 2026
• MK-3475A±Calderasib (MK-1084) in Completely Resected Stage IIA-IIIB (N2) KRAS G12Cm NSCLC (MK-1084-013)

  NCT07431827

  RecruitingInterventionalPhase 3Updated Aug 28, 2026
• A Study of Calderasib (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)

  NCT06345729

  RecruitingInterventionalPhase 3Updated Sep 8, 2026
• A Clinical Study of Calderasib (MK-1084) With Targeted Therapy and Chemotherapy in People With Colorectal Cancer (MK-1084-012/KANDLELIT-012)

  NCT06997497

  RecruitingInterventionalPhase 3Updated Sep 9, 2026
• A Clinical Study of Calderasib (MK-1084) in People With Advanced Solid Tumors (MK-1084-014)

  NCT07209111

  RecruitingInterventionalPhase 2Updated Aug 21, 2026
• A Study of Calderasib (MK-1084) in KRAS Mutant Advanced Solid Tumors (MK-1084-001)

  NCT05067283

  RecruitingInterventionalPhase 1Updated Jul 31, 2026