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

Conditions

• Squamous Non-small Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Intismeran Autogene — BIOLOGICAL
  1 mg Intramuscular (IM) Injection
• Pembrolizumab — BIOLOGICAL
  200 mg IV Infusion
• Carboplatin — DRUG
  Area Under the Curve (AUC) either 6 or 5 (mg/mL/min) IV Infusion
• Paclitaxel — DRUG
  200 or 175 mg/m\^2 IV Infusion
• Nab-paclitaxel — DRUG
  100 mg/m\^2 IV Infusion
• Placebo — OTHER
  Placebo matched to Intismeran Autogene IM injection

Study Details

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.

Key Dates

Start date

Dec 12, 2025

Status verified

Jun 2026

Primary completion

Jul 2, 2029

Completion

May 6, 2031

Study Design

Enrollment

180 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Intismeran Autogene + Pembrolizumab + Chemo
  Induction phase: Participants receive pembrolizumab 400 mg intravenous (IV) infusion on Day 1 of a six week cycle plus a platinum doublet chemotherapy regimen (carboplatin area under the curve (AUC) 6 or 5 mg/mL/min IV infusion every 3 weeks (Q3W) × 2 doses combined either with paclitaxel 200 or 175 mg/m\^2 IV infusion Q3W × 2 doses, OR with nab paclitaxel 100 mg/m\^2 IV infusion weekly × 6 doses). Intismeran Autogene 1 mg intramuscular (IM) injection is administered on Days 1 and 22 of Cycle 2 Induction (Q3W) for up to 2 doses. Maintenance phase: Participants receive pembrolizumab 400 mg IV infusion on Day 1 every 6 weeks (Q6W) for up to 15 doses. Intismeran Autogene 1 mg IM injection is administered on Days 1 and 22 (Q3W) for up to 7 doses during maintenance.
• Experimental: Placebo + Pembrolizumab + Chemo
  Induction phase: Participants receive pembrolizumab 400 mg intravenous (IV) infusion on Day 1 of a six week cycle plus a platinum doublet chemotherapy regimen (carboplatin area under the curve (AUC) 6 or 5 mg/mL/min IV infusion every 3 weeks (Q3W) × 2 doses combined either with paclitaxel 200 or 175 mg/m\^2 IV infusion Q3W × 2 doses, OR with nab paclitaxel 100 mg/m\^2 IV infusion weekly × 6 doses). Placebo intramuscular (IM) injection is administered on Days 1 and 22 of Cycle 2 Induction (Q3W) for up to 2 doses. Maintenance phase: Participants receive pembrolizumab 400 mg IV infusion on Day 1 every 6 weeks (Q6W) for up to 15 doses. Placebo IM injection is administered on Days 1 and 22 (Q3W) for up to 7 doses during maintenance.

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: Up to ~32 months ]

Central Contacts

• Toll Free Number
  1-888-577-8839
  [email protected]

Locations (7)

Find similar trials in Tampa, FL

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