NCT07221474

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

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of V940 in Combination With Pembrolizumab and Chemotherapy as First-Line Treatment for Participants With Metastatic Squamous NSCLC (INTerpath-013)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Squamous Non-small Cell Lung Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Intismeran Autogene	1 mg Intramuscular (IM) Injection
BIOLOGICAL	Pembrolizumab	200 mg IV Infusion
DRUG	Carboplatin	Area Under the Curve (AUC) 6 (mg/mL/min) IV Infusion
DRUG	Paclitaxel	200 mg/m\^2 IV Infusion
DRUG	Nab-paclitaxel	100 mg/m\^2 IV Infusion
OTHER	Placebo	Placebo matched to Intismeran Autogene IM injection

Timeline

• Start date: 2025-12-12
• Primary completion: 2029-07-02
• Completion: 2031-05-06
• First posted: 2025-10-28
• Last updated: 2026-04-13

Locations

32 sites across 9 countries: United States, Argentina, Australia, Chile, France, Poland, South Korea, Taiwan, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study