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

NCT07554339 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 5 other identifiers: 1084-0152025-522038-29-00U1111-1321-6971MK-1084-015KANDLELIT-015
• Study Type: interventional
• Target: 310
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to approximately 6 years

Secondary Outcomes (9)

• Overall Survival (OS)

  Up to approximately 9 years

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

  Up to approximately 9 years

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

  Up to approximately 9 years

• Objective Response Rate (ORR)

  Up to approximately 9 years

• Duration of Response (DOR)

  Up to approximately 9 years

Study Arms (2)

Calderasib + Durvalumab

EXPERIMENTAL

Participants will receive calderasib and durvalumab.

Drug: Calderasib; Biological: Durvalumab

Placebo + Durvalumab

ACTIVE COMPARATOR

Participants will receive placebo to calderasib and durvalumab.

Biological: Durvalumab; Other: Placebo to MK-1084

Interventions

Calderasib DRUG

Tablet for oral administration.

Also known as: MK-1084

Calderasib + Durvalumab

Durvalumab BIOLOGICAL

Solution for intravenous (IV) infusion.

Also known as: IMFINZI®

Calderasib + Durvalumab; Placebo + Durvalumab

Placebo to MK-1084 OTHER

Placebo to MK-1084.

Placebo + Durvalumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

durvalumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Medical Director

  Merck Sharpe & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: April 28, 2026
• Study Start (Estimated): June 5, 2026
• Primary Completion (Estimated): December 15, 2032
• Study Completion (Estimated): August 17, 2037
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share