Clinical Trial

A Study of Intismeran Autogene (V940)/Placebo + Pembrolizumab and Chemotherapy in Metastatic Squamous Non-Small Cell Lung Cancer (V940-013)

Study acronym: INTerpath-13

Recruiting Phase 2

Summary

Researchers want to know if intismeran autogene (the study treatment) given with pembrolizumab and chemotherapy can treat metastatic treatment-naive squamous non-small cell lung cancer (NSCLC). Intismeran autogene is designed to help a person's immune system attack their specific cancer. The goal of this study is to learn if people who receive intismeran autogene with pembrolizumab and chemotherapy live longer overall and without the cancer growing or spreading compared to people who receive placebo with pembrolizumab and chemotherapy. A placebo looks like the study treatment but has no study treatment in it. Using a placebo helps researchers better understand the effects of the study treatment.

Protocol Amendment History 4 changes

notable Trial sites expanded: 47 -> 51 locations 2026-06-10

notable Trial sites expanded: 43 -> 46 locations 2026-05-27

notable Trial sites expanded: 32 -> 43 locations 2026-05-14

notable Trial sites expanded: 25 -> 32 locations 2026-04-14

Trial Details

NCT Number	NCT07221474
Lead Sponsor	Merck Sharp & Dohme LLC Collaborators: ModernaTX, Inc.
Conditions	Squamous Non-small Cell Lung Cancer
Enrollment	180 participants
Start Date	2025-12-12
Primary Completion	2029-07-02 (estimated)
Study Completion	2031-05-06 (estimated)
Updated on ClinicalTrials.gov	2026-07-10