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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
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
Conditions
Interventions
Intismeran Autogene
1 mg Intramuscular (IM) Injection
Pembrolizumab
200 mg IV Infusion
Carboplatin
Area Under the Curve (AUC) either 6 or 5 (mg/mL/min) IV Infusion
Paclitaxel
200 or 175 mg/m\^2 IV Infusion
Nab-paclitaxel
100 mg/m\^2 IV Infusion
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)