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Clinical Trials in the EU / 2025-522643-18-00
Authorised, recruiting Phase III

A Phase 3, Randomized, Placebo-Controlled Study of Adjuvant Intismeran Autogene Plus Subcutaneous Pembrolizumab and Berahyaluronidase Alfa (MK-3475A) or Intismeran Autogene Monotherapy Versus Placebo in Participants With Completely Resected High-Risk Stage I Non-Small Cell Lung Cancer (INTerpath-014)

2025-522643-18-00 · tracked via the Priya Life Science EU tracker
Sponsor
Merck Sharp & Dohme LLC
Sponsor type
Pharmaceutical company
Therapeutic area
Neoplasms
Decision date
16/06/2026
Enrollment target
283
Sites
Greece, Poland, Italy, Hungary, Germany, Netherlands, France, Spain

Condition studied

Stage I NSCLC

Investigational medicinal product(s)

MK-3475AmRNA-4157Placebo to V940

Every trial of Pembrolizumab Formulated with Berahyaluronidase Alfa and Intismeran autogene across our registers →

Eligibility

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

Primary endpoint

Disease-Free Survival (DFS) as assessed by Blinded Independent Central Review (BICR) in participants with nonsquamous non-small cell lung cancer (NSCLC) in Arm A and Arm C

Endpoint detail

DFS as assessed by BICR, Distant metastasis-free survival (DMFS), Overall Survival (OS), Number Participants Who Experience an Adverse Events (AE), Number of Participants Who Discontinue Study Treatment Due to an AE, Change From Baseline in European Organization for Research and Treatment (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Combined Global Health Status/Quality of Life (Items 29 & 30) Scale Combined Score, Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Score, Change From Baseline in Role Functioning (EORTC QLQ-C30 Items 6-7) Score

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 2025-522643-18-00 on CTIS ↗ ← All trials in the EU