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RECRUITING
NCT07221474
PHASE2

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

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

180

Start Date

2025-12-12

Completion Date

2031-05-06

Last Updated

2026-05-28

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) 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

Locations (47)

Moffitt Cancer Center ( Site 0021)

Tampa, Florida, United States

Washington University School of Medicine ( Site 0024)

St Louis, Missouri, United States

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

Texas Oncology - Central/South Texas ( Site 8002)

Austin, Texas, 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

Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1001)

Roma, Italy

Wielkopolskie Centrum Pulmonologii i Torakochirurgii ( Site 1101)

Poznan, Greater Poland Voivodeship, Poland

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Site 1100)

Warsaw, Masovian 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

ICO L Hospitalet ( Site 1311)

Hospitalet, Barcelona, Spain

Hospital Jerez de la Frontera-UGC Oncología ( Site 1315)

Jerez de la Frontera, Cadiz, Spain

Hospital Universitari Vall d''Hebron ( Site 1310)

Barcelona, Spain

Hospital Ramon y Cajal ( Site 1314)

Madrid, Spain

Hospital Clinico San Carlos... ( Site 1313)

Madrid, Spain

Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 1312)

Seville, Spain

National Cheng Kung University Hospital ( Site 0601)

Tainan, Taiwan

Mackay Memorial Hospital ( Site 0604)

Taipei, Taiwan

National Taiwan University Cancer Center (NTUCC) ( Site 0600)

Taipei, Taiwan

Taipei Veterans General Hospital ( Site 0602)

Taipei, Taiwan

Chang Gung Medical Foundation-Linkou Branch ( Site 0605)

Taoyuan, Taiwan

Hacettepe Universitesi Tıp Fakultesi ( Site 1400)

Ankara, Turkey (Türkiye)

Memorial Ankara Hastanesi ( Site 1401)

Ankara, Turkey (Türkiye)

Ankara Bilkent Şehir Hastanesi ( Site 1402)

Ankara, Turkey (Türkiye)

Koç Üniversitesi Hastanesi ( Site 1403)

Istanbul, Turkey (Türkiye)