RecruitingPhase 2NCT07221474

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

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)

Sponsor

Merck Sharp & Dohme LLC

Enrollment

180 participants

Start Date

Dec 12, 2025

Study Type

INTERVENTIONAL

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (V940-013) is testing whether adding a personalized mRNA cancer vaccine (V940) to the standard immunotherapy and chemotherapy combination improves outcomes for people with advanced squamous non-small cell lung cancer that has spread throughout the body. **You may be eligible if...** - You have Stage IV squamous non-small cell lung cancer (confirmed by biopsy or pathology) - Your cancer has measurable disease on imaging - You have tumor tissue available for testing - Your PD-L1 status has been determined - You are in good general health (ECOG 0 or 1) - Any side effects from previous treatments have resolved **You may NOT be eligible if...** - Your tumor has certain genetic mutations that have specific targeted treatments available (such as EGFR, ALK, ROS1, or KRAS G12C) - You have small cell elements in your tumor - Your side effects from prior treatments have not resolved Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALIntismeran Autogene

1 mg Intramuscular (IM) Injection

BIOLOGICALPembrolizumab

200 mg IV Infusion

DRUGCarboplatin

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

DRUGPaclitaxel

200 mg/m\^2 IV Infusion

DRUGNab-paclitaxel

100 mg/m\^2 IV Infusion

OTHERPlacebo

Placebo matched to Intismeran Autogene IM injection

Locations(32)

Valley Health Systems - Ridgewood Campus ( Site 0010)

Paramus, New Jersey, United States

Cleveland Clinic - Ohio ( Site 0016)

Cleveland, Ohio, United States

Tennessee Oncology, PLLC - Elliston Place Plaza Medical Oncology & Hematology ( Site 9000)

Nashville, Tennessee, United States

Virginia Cancer Specialists ( Site 0003)

Fairfax, Virginia, United States

Hospital Italiano de Buenos Aires ( Site 0200)

Ciudad Autonoma de Buenos Aires., Buenos Aires, Argentina

Instituto Alexander Fleming ( Site 0201)

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Instituto de Investigaciones Clínicas Mar del Plata ( Site 0205)

Mar del Plata, Buenos Aires, Argentina

Clinica Adventista Belgrano ( Site 0206)

Caba., Buenos Aires F.D., Argentina

Fundacion Estudios Clinicos ( Site 0207)

Rosario, Santa Fe Province, Argentina

Sanatorio Parque ( Site 0203)

Rosario, Santa Fe Province, Argentina

Westmead Hospital ( Site 0400)

Westmead, New South Wales, Australia

Princess Alexandra Hospital ( Site 0403)

Woolloongabba, Queensland, Australia

One Clinical Research ( Site 0402)

Nedlands, Western Australia, Australia

Centro de Estudios Clínicos SAGA ( Site 0307)

Santiago, Region M. de Santiago, Chile

FALP ( Site 0300)

Santiago, Region M. de Santiago, Chile

Bradfordhill ( Site 0301)

Santiago, Region M. de Santiago, Chile

Bradford Hill Norte ( Site 0308)

Antofagasta, Chile

Centre Georges François Leclerc ( Site 0805)

Dijon, Cote-d Or, France

Institut de Cancérologie de l'Ouest ( Site 0801)

Angers, Pays de la Loire Region, France

CHU GABRIEL MONTPIED ( Site 0802)

Clermont-Ferrand, Puy-de-Dome, France

Wielkopolskie Centrum Pulmonologii i Torakochirurgii ( Site 1101)

Poznan, Greater Poland Voivodeship, Poland

Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1102)

Przemyśl, Podkarpackie Voivodeship, Poland

National Cancer Center ( Site 0504)

Goyang-si, Kyonggi-do, South Korea

Seoul National University Bundang Hospital ( Site 0500)

Seongnam-si, Kyonggi-do, South Korea

Chungbuk National University Hospital-Internal medicine ( Site 0501)

Cheongju-si, North Chungcheong, South Korea

Asan Medical Center ( Site 0503)

Seoul, South Korea

Samsung Medical Center ( Site 0502)

Seoul, South Korea

National Cheng Kung University Hospital ( Site 0601)

Tainan, Taiwan

Mackay Memorial Hospital ( Site 0604)

Taipei, Taiwan

Chang Gung Medical Foundation-Linkou Branch ( Site 0605)

Taoyuan, Taiwan

Hacettepe Universitesi Tıp Fakultesi ( Site 1400)

Ankara, Turkey (Türkiye)

Ankara Bilkent Şehir Hastanesi ( Site 1402)

Ankara, Turkey (Türkiye)

View Full Details on ClinicalTrials.gov

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NCT07221474