Clinical Trials List
2026-03-01 - 2043-12-31
Phase III
Recruiting5
A Phase 3, Randomized, Double-blind Study of Adjuvant MK-1084 Plus Subcutaneous Pembrolizumab and Berahyaluronidase Alfa (MK-3475A) Versus Adjuvant Placebo Plus MK-3475A in Participants With Completely Resected Stage IIA-IIIB (N2), KRAS G12C-mutant Non-small Cell Lung Cancer Following Receipt of Either Neoadjuvant Pembrolizumab Plus Chemotherapy or Adjuvant Chemotherapy (KANDLELIT-013)
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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
Co-Principal Investigator
- 吳尚俊 無
- 林宗哲 無
- YEN-TING LIN 無
- Chia-Chi Lin 無
- JIN-YUAN SHIH 無
- 黃信端 無
- 黃得瑞 無
- James Chih-Hsin Yang 無
- 劉芳瑜 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
皮下注射劑
Active Ingredient
Humanized X PD-1_mAb (H409A11) IgG4 (Pembrolizumab and berahyaluronidase alfa)
Dosage Form
220
Dosage
165 mg/mL pembrolizumab and 13.8 μg/mL (2000 U/mL) MK-5180 (berahyaluronidase alfa)/vial
Endpoints
Inclution Criteria
Has a histological/cytological diagnosis of non-small cell lung cancer (NSCLC) with predominantly nonsquamous histology and meets one of the following criteria:
Has newly diagnosed, treatment-naïve, resectable, clinical Stage IIA-IIIB (N2) NSCLC
Has completely resected, pathological Stage IIA-IIIB (N2) NSCLC, including those previously treated outside the study with neoadjuvant platinum-doublet chemotherapy plus pembrolizumab or MK-3475A, or those who received adjuvant platinum-doublet chemotherapy.
Tumor tissue shows the presence of Kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation
No more than 12 weeks have elapsed between either the surgery following neoadjuvant treatment or last dose of adjuvant platinum-based chemotherapy and the first dose of investigational adjuvant study intervention.
Has no evidence of disease based on postsurgical radiological assessment as documented by contrast-enhanced chest/abdomen computed tomography (or magnetic resonance imaging) within 28 days before randomization
Has an Eastern Cooperative Oncology Group performance status of 0 or 1 within 10 days before the first dose of the study intervention
Human immunodeficiency virus-infected participants must have well controlled HIV on antiretroviral therapy
Participants who are Hepatitis B surface antigen positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy and have undetectable HBV viral load
Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable
Exclusion Criteria
Has a diagnosis of any 1 of the following tumor types/locations: small cell lung cancer or, for mixed tumors, presence of small cell elements, neuroendocrine tumor with large cell components, sarcomatoid carcinoma, or NSCLC involving the superior sulcus
HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, chronic diarrhea)
Has uncontrolled, significant cardiovascular disease or cerebrovascular disease within the 6 months preceding study intervention
Is unable to swallow orally administered medication, or has a gastrointestinal disorder affecting absorption (e.g. gastrectomy, partial bowel obstruction, or malabsorption)
Has 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 except replacement therapy
Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
Has active infection requiring systemic therapy
Has not adequately recovered from major surgery or has ongoing surgical complications
The Estimated Number of Participants
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Taiwan
12 participants
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Global
400 participants
