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)

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.

Eligibility

Age range

18+ years

Sex

All

Healthy volunteers

No

Interventions

• 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

Locations (32)