Phase 2 Study of Intismeran Autogene With Pembrolizumab and Chemotherapy for First-Time Treatment of Metastatic Squamous Non-Small Cell Lung Cancer

What this Trial Is About

Researchers are investigating whether intismeran autogene, combined with pembrolizumab and chemotherapy, can help treat people with metastatic squamous non-small cell lung cancer NSCLC who have not received prior treatment. The study aims to determine if this combination improves overall survival and delays cancer growth or spread compared to pembrolizumab and chemotherapy with a placebo. Intismeran autogene is designed to stimulate the immune system to attack the cancer. Participants are divided into two groups. In the induction phase, all receive pembrolizumab through intravenous IV infusion on Day 1 of a six-week cycle plus platinum-based chemotherapy every three weeks, combined with either paclitaxel or nab-paclitaxel, depending on the group. The study treatment or placebo is given by intramuscular IM injection on Days 1 and 22 during the second cycle of induction. During the maintenance phase, pembrolizumab is given every six weeks for up to 15 doses, and the study treatment or placebo is administered by IM injection on Days 1 and 22 every three weeks for up to 7 doses. Throughout the study, participants undergo regular assessments including imaging to measure cancer progression and survival. Researchers monitor overall survival and progression-free survival for up to about 42 months. Additional outcomes include response rates to treatment and adverse events. Participants are closely observed for safety, and the study lasts several years to evaluate long-term effects and benefits of the treatment combination.

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