NCT06623422

A Study of Pembrolizumab (MK-3475) With or Without Intismeran Autogene (V940) in Participants With Non-small Cell Lung Cancer (V940-009/INTerpath-009)

A Phase 3 Randomized Double-blind Study of Adjuvant Pembrolizumab With or Without V940 in Participants With Resectable Stage II to IIIB (N2) NSCLC Not Achieving pCR After Receiving Neoadjuvant Pembrolizumab With Platinum-based Doublet Chemotherapy (INTerpath-009)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 680 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to learn if people who receive intismeran autogene and pembrolizumab after surgery are cancer-free longer than people who receive placebo and pembrolizumab. Researchers want to know if giving intismeran autogene and pembrolizumab after surgery can help prevent the cancer from coming back in people with non-small cell lung cancer (NSCLC) whose tumors did not respond completely to treatment before surgery (neoadjuvant treatment).

Conditions

• Carcinoma, Non-Small-Cell Lung

Interventions

Type	Name	Description
BIOLOGICAL	Pembrolizumab	IV Infusion
DRUG	Cisplatin	IV infusion
DRUG	Carboplatin	IV infusion
DRUG	Pemetrexed	IV infusion
DRUG	Gemcitabine	IV infusion
DRUG	Paclitaxel	IV infusion
BIOLOGICAL	Intismeran autogene	IM injection
OTHER	Placebo	IM injection

Timeline

• Start date: 2024-10-21
• Primary completion: 2033-05-16
• Completion: 2038-01-26
• First posted: 2024-10-02
• Last updated: 2026-04-14

Locations

229 sites across 31 countries: United States, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Netherlands, New Zealand, Peru, Poland, Romania, Singapore, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study