A Study of Intismeran Autogene (V940)/Placebo + Pembrolizumab and Chemotherapy in Metastatic Squamous Non-Small Cell Lung Cancer (V940-013)
Start Date
12/12/2025
Completion Date
5/6/2031
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 Criteria
Age Range: 18 years to No maximum
Interventions
Intismeran Autogene
Pembrolizumab
Carboplatin
Paclitaxel
Nab-paclitaxel
Placebo
Conditions
Locations
Moffitt Cancer Center ( Site 0021)
Tampa, Florida 33612
United States
Washington University School of Medicine ( Site 0024)
St Louis, Missouri 63110
United States
Valley Health Systems - Ridgewood Campus ( Site 0010)
Paramus, New Jersey 07652
United States
New York Oncology Hematology (NYOH) - Albany Medical Center ( Site 9001)
Albany, New York 12206
United States
Cleveland Clinic - Ohio ( Site 0016)
Cleveland, Ohio 44195
United States
Good Samaritan Regional Medical Center-Samaritan Pastega Regional Cancer Center ( Site 0025)
Corvallis, Oregon 97330
United States
Tennessee Oncology, PLLC - Elliston Place Plaza Medical Oncology & Hematology ( Site 9000)
Nashville, Tennessee 37203
United States
Texas Oncology - Central/South Texas ( Site 8002)
Austin, Texas 78745
United States
Virginia Cancer Specialists ( Site 0003)
Fairfax, Virginia 22031
United States
Swedish Medical Center-Swedish Cancer Institute ( Site 0023)
Seattle, Washington 98104
United States
Hospital Italiano de Buenos Aires ( Site 0200)
Ciudad Autonoma de Buenos Aires., Buenos Aires C1199ABB
Argentina
Instituto Alexander Fleming ( Site 0201)
Ciudad Autonoma de Buenos Aires, Buenos Aires C1426ANZ
Argentina
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0205)
Mar del Plata, Buenos Aires B7600FZO
Argentina
Clinica Adventista Belgrano ( Site 0206)
Caba., Buenos Aires F.D. C1430EGF
Argentina
Fundacion Estudios Clinicos ( Site 0207)
Rosario, Santa Fe Province S2000DSV
Argentina
Sanatorio Parque ( Site 0203)
Rosario, Santa Fe Province S2000DSV
Argentina
Westmead Hospital ( Site 0400)
Westmead, New South Wales 2145
Australia
Princess Alexandra Hospital ( Site 0403)
Woolloongabba, Queensland 4102
Australia
One Clinical Research ( Site 0402)
Nedlands, Western Australia 6009
Australia
Centro de Estudios Clínicos SAGA ( Site 0307)
Santiago, Region M. de Santiago 7500653
Chile
FALP ( Site 0300)
Santiago, Region M. de Santiago 7500921
Chile
Bradfordhill ( Site 0301)
Santiago, Region M. de Santiago 8420383
Chile
Bradford Hill Norte ( Site 0308)
Antofagasta, 1263521
Chile
Centre Georges François Leclerc ( Site 0805)
Dijon, Cote-d Or 21000
France
Institut de Cancérologie de l'Ouest ( Site 0801)
Angers, Pays de la Loire Region 49055
France
CHU GABRIEL MONTPIED ( Site 0802)
Clermont-Ferrand, Puy-de-Dome 63001
France
Ospedale Santa Maria delle Croci-Dipartimento Oncoematologico ( Site 1004)
Ravenna, Emilia-Romagna 48121
Italy
Ospedale San Raffaele-Oncologia Medica ( Site 1002)
Milan, 20132
Italy
Fondazione IRCCS Istituto Nazionale Dei Tumori ( Site 1000)
Milan, 20133
Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1001)
Roma, 00168
Italy
Wielkopolskie Centrum Pulmonologii i Torakochirurgii ( Site 1101)
Poznan, Greater Poland Voivodeship 60-569
Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Site 1100)
Warsaw, Masovian Voivodeship 02-781
Poland
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1102)
Przemyśl, Podkarpackie Voivodeship 37-700
Poland
National Cancer Center ( Site 0504)
Goyang-si, Kyonggi-do 10408
South Korea
Seoul National University Bundang Hospital ( Site 0500)
Seongnam-si, Kyonggi-do 13620
South Korea
Chungbuk National University Hospital-Internal medicine ( Site 0501)
Cheongju-si, North Chungcheong 28644
South Korea
Asan Medical Center ( Site 0503)
Seoul, 05505
South Korea
Samsung Medical Center ( Site 0502)
Seoul, 06351
South Korea
ICO L Hospitalet ( Site 1311)
Hospitalet, Barcelona 08907
Spain
Hospital Jerez de la Frontera-UGC Oncología ( Site 1315)
Jerez de la Frontera, Cadiz 11407
Spain
Hospital Universitari Vall d''Hebron ( Site 1310)
Barcelona, 08035
Spain
Hospital Ramon y Cajal ( Site 1314)
Madrid, 28034
Spain
Hospital Clinico San Carlos... ( Site 1313)
Madrid, 28040
Spain
Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 1312)
Seville, 41009
Spain
China Medical University Hospital ( Site 0606)
Taichung, 404
Taiwan
National Cheng Kung University Hospital ( Site 0601)
Tainan, 70403
Taiwan
Mackay Memorial Hospital ( Site 0604)
Taipei, 104
Taiwan
National Taiwan University Cancer Center (NTUCC) ( Site 0600)
Taipei, 106
Taiwan
Taipei Veterans General Hospital ( Site 0602)
Taipei, 11217
Taiwan
Chang Gung Medical Foundation-Linkou Branch ( Site 0605)
Taoyuan, 33305
Taiwan
Hacettepe Universitesi Tıp Fakultesi ( Site 1400)
Ankara, 06230
Turkey (Türkiye)
Memorial Ankara Hastanesi ( Site 1401)
Ankara, 06520
Turkey (Türkiye)
Ankara Bilkent Şehir Hastanesi ( Site 1402)
Ankara, 06800
Turkey (Türkiye)
Koç Üniversitesi Hastanesi ( Site 1403)
Istanbul, 34010
Turkey (Türkiye)