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)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-522643-18-00

Enrollment

137

Registered

2026-06-16

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stage I NSCLC

Brief summary

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

Detailed description

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

Interventions

DRUGPlacebo to V940

DRUGMK-3475A

DRUGmRNA-4157

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
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	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

—

Outcome results

None listed

Source: EU CTIS · Data processed: Jun 18, 2026