Clinical Trials List
2026-05-01 - 2038-12-31
Phase III
Not yet recruiting5
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)
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Trial Applicant
Merck Sharp & Dohme (I.A.) LLC
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2026/09/10
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- James Chih-Hsin Yang 無
- JIN-YUAN SHIH 無
- 黃信端 無
- Chia-Chi Lin 無
- YEN-TING LIN 無
- 黃得瑞 無
- 吳尚俊 無
- 林宗哲 無
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Condition/Disease
Objectives
Test Drug
注射劑
Active Ingredient
Durvalumab
Dosage Form
270
Dosage
50 mg/ml
Endpoints
Inclution 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.
The Estimated Number of Participants
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Taiwan
10 participants
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Global
310 participants
