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Clinical Trials in the EU / 2024-517337-41-00
Authorised, recruiting Phase III

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)

2024-517337-41-00 · tracked via the Priya Life Science EU tracker
Sponsor
Merck Sharp & Dohme LLC
Sponsor type
Pharmaceutical company
Therapeutic area
Neoplasms
Decision date
20/04/2026
Enrollment target
102
Sites
Italy, Spain, Germany, Poland, Greece, France

Condition studied

Completely resected Stage IIA-IIIB (N2) KRAS G12C mutated NSCLC

Investigational medicinal product(s)

Placebo for MK-1084CISPLATINCARBOPLATINPEMETREXEDMK-1084MK-3475A

Eligibility

Age group
65+ years, 18-64 years
Sex
Female, Male

Primary endpoint

Disease-Free Survival (DFS)

Endpoint detail

Overall Survival (OS), Distant Metastasis-Free Survival (DMFS), Lung Cancer Specific Survival (LCSS), Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score, Change from Baseline in the EORTC-QLQ-C30 Physical Functioning (Items 1-5) Combined Score, Change from Baseline in the EORTC-QLQ-C30 Role Functioning (Items 6 and 7) Combined Score, Change from Baseline in the EORTC-QLQ-C30 Dyspnea (Item 8) Score, Change from Baseline in the EORTC-Quality of Life Questionnaire-Lung Cancer 24 (QLQ-LC24) Coughing (Items 31 and 52) Combined Score, Change from Baseline in the EORTC-QLQ-LC24 Chest Pain (Item 40) Score, Number of Participants Who Experience an Adverse Event (AE), Number of Participants Who Discontinue Study Treatment Due to an AE

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2024-517337-41-00 on CTIS ↗ ← All trials in the EU