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

NCT07221474 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2026-05-13

No results posted yet for this study

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.

Conditions

  • Squamous Non-small Cell Lung Cancer

Interventions

BIOLOGICAL

Intismeran Autogene

1 mg Intramuscular (IM) Injection

BIOLOGICAL

Pembrolizumab

200 mg IV Infusion

DRUG

Carboplatin

Area Under the Curve (AUC) either 6 or 5 (mg/mL/min) IV Infusion

DRUG

Paclitaxel

200 or 175 mg/m\^2 IV Infusion

DRUG

Nab-paclitaxel

100 mg/m\^2 IV Infusion

OTHER

Placebo

Placebo matched to Intismeran Autogene IM injection

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-12
Primary Completion
2029-07-02
Completion
2031-05-06
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Chile
  • France
  • Poland
  • South Korea
  • Spain
  • Taiwan
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07221474 on ClinicalTrials.gov