Actively Recruiting
A Phase 3, Randomized, Double-blind Study of MK-1084 Calderasib Plus Durvalumab Versus Placebo Plus Durvalumab in Locally Advanced, Unresected KRAS G12C-Mutant Non-Small Cell Lung Cancer After Chemoradiotherapy
Led by Merck Sharp & Dohme LLC · Updated on 2026-06-03
310
Participants Needed
5
Research Sites
243 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are investigating new treatment options for people with locally advanced non-small cell lung cancer NSCLC that cannot be surgically removed and has a specific gene mutation called KRAS G12C. The study aims to find out if combining the drug calderasib MK-1084 with durvalumab, an immunotherapy, can help patients live longer without their cancer growing or spreading after they have completed chemotherapy and radiation therapy. This is a Phase 3 randomized clinical trial sponsored by Merck Sharp Dohme LLC. Participants in this study will be randomly assigned to receive either calderasib plus durvalumab or a placebo plus durvalumab. Calderasib is given as a tablet taken by mouth, while durvalumab is administered through an intravenous IV infusion. The study uses a double-blind design, meaning neither participants nor researchers know who receives the active drug or placebo. Patients must have completed prior platinum-based chemoradiotherapy without disease progression to join. During the trial, participants will be closely monitored for how long they live without cancer progression, known as progression-free survival, for up to about six years. Additional outcomes include overall survival, response rates, adverse events, quality of life, and other health measures tracked for up to nine years. Researchers will collect tumor tissue samples and assess biomarkers such as PD-L1 status. Safety and treatment effects will be evaluated throughout the study, which will last several years.
CONDITIONS
Brief Title
A Clinical Trial of Calderasib (MK-1084) and Durvalumab in People With Non-Small Cell Lung Cancer (MK-1084-015/KANDLELIT-015)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histological or cytological diagnosis of locally advanced, unresected Stage II (node-positive) to III non-small cell lung cancer with mostly nonsquamous histology
- Completed definitive platinum-based concurrent chemoradiotherapy prior to enrollment without disease progression
- Provided tumor tissue for central testing of KRAS G12C mutation, PD-L1 status, and biomarker research
- Tumor tissue shows KRAS G12C mutation and has an evaluable PD-L1 result
- If HIV-positive, well-controlled on antiretroviral therapy
- If hepatitis B surface antigen-positive, has undetectable HBV viral load and received antiviral therapy
- If history of hepatitis C, has undetectable viral load
- Body weight of at least 35 kg
You will not qualify if you...
- Diagnosis of small cell lung cancer or mixed tumors with small cell elements
- Gastrointestinal disorder affecting absorption or inability to swallow oral medication
- Active inflammatory bowel disease requiring immunosuppressive medication or history of inflammatory bowel disease
- Uncontrolled significant cardiovascular or cerebrovascular disease
- HIV infection with history of Kaposi's sarcoma or Multicentric Castleman's Disease
- Prior treatment for NSCLC other than definitive chemoradiotherapy
- Known additional progressing malignancy requiring treatment in past 3 years
- Active autoimmune disease requiring systemic treatment in past 2 years
- History or current pneumonitis/interstitial lung disease requiring steroids
- Active infection requiring systemic therapy
- History of stem cell or solid organ transplant
- Not adequately recovered from major surgery or ongoing surgical complications
Research Team
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