drugset
drugset / Trial / 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)

NCT06623422 ↗

Phase 3 Recruiting 680 enrolled Merck Sharp & Dohme LLC ModernaTX, Inc. · collab
RandomizedParallel-groupDouble-blindTreatment

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).

Timeline

Start
2024-10-21
Primary completion
2033-05-16
Completion
2038-01-26

Drugs

EvaluationDrugModalityDoseRoute
Subject Intismeran autogene Messenger RNA (mRNA) 1 mg Intramuscular
Background Carboplatin Small molecule 5 unknown Intravenous
Background Carboplatin Small molecule 6 unknown Intravenous
Background Cisplatin Other / unclassified 75 mg/m2 Intravenous
Background Gemcitabine Small molecule 1000 mg/m2 Intravenous
Background Paclitaxel Small molecule 175 mg/m2 Intravenous
Background Paclitaxel Small molecule 200 mg/m2 Intravenous
Background Pembrolizumab Monoclonal antibody 400 mg Intravenous
Background Pemetrexed Small molecule 500 mg/m2 Intravenous

Indications

non-small cell lung carcinoma