Phase
Condition
N/ATreatment
V940
Placebo
Intismeran autogene
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
Has histologically/cytologically confirmed diagnosis of previously untreated andpathologically confirmed resectable Stage II, IIIA, or IIIB (N2) non-small cell lungcancer (NSCLC) [American Joint Committee on Cancer (AJCC) 8th Edition]
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before the first dose of study intervention
Participants who have not achieved a pathological complete response (pCR) followingcompletion of neoadjuvant chemotherapy and pembrolizumab followed by surgery will beeligible
Confirmation that epidermal growth factor receptor (EGFR)-directed therapy is notindicated as primary therapy (documentation of absence of tumor-activating EGFRmutations [eg, DEL19 or L858R])
Human immunodeficiency virus (HIV)-infected participants must have well controlledHIV on anti-retroviral therapy (ART)
Participants who are hepatitis B surface antigen (HBsAg) positive are eligible ifthey have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeksand have undetectable HBV viral load prior to randomization
Participants with history of hepatitis C virus (HCV) infection are eligible if HCVviral load is undetectable at screening
Exclusion
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
Diagnosis of SCLC or, for mixed tumors, presence of small cell elements, or has aneuroendocrine tumor with large-cell components, or a sarcomatoid carcinoma, or apancoast tumor
Documentation by local test report indicating presence of anaplastic lymphoma kinase (ALK) gene rearrangements
Received prior neoadjuvant therapy for their current NSCLC diagnosis
Received prior therapy with an anti-programmed cell death 1 (PD-1), anti-programmedcell death ligand 1 (PD-L1), or anti-programmed cell-death ligand 2 (PD-L2) agent,or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein [CTLA-4], OX-40, CD137)
Received prior systemic anticancer therapy including investigational agents otherthan what is specified in this protocol
Received prior treatment with a cancer vaccine
Received prior radiotherapy within 2 weeks of start of study intervention, or hasradiation-related toxicities, requiring corticosteroids
Received a live or live-attenuated vaccine within 30 days before the first dose ofstudy intervention
Study Design
Connect with a study center
CEMIC ( Site 2454)
Caba, Buenos Aires C1431FWO
ArgentinaSite Not Available
CEMIC ( Site 2454)
Caba., Buenos Aires C1431FWO
ArgentinaActive - Recruiting
Fundacion Intecnus ( Site 2456)
San Carlos de Bariloche, Rio Negro R8402APU
ArgentinaActive - Recruiting
Centro Médico IPAM ( Site 2452)
Rosario, Santa Fe S2001SBK
ArgentinaActive - Recruiting
Instituto Medico Especializado Alexander Fleming ( Site 2457)
Buenos Aires, C1426ANZ
ArgentinaActive - Recruiting
Instituto Oncologico de Cordoba -IONC ( Site 2455)
Cordoba, X5001HWE
ArgentinaActive - Recruiting
Calvary Mater Newcastle ( Site 2106)
Waratah, New South Wales 2298
AustraliaActive - Recruiting
Tasman Oncology Research ( Site 2104)
Southport, Queensland 4215
AustraliaActive - Recruiting
Grampians Health ( Site 2101)
Ballarat, Victoria 3350
AustraliaActive - Recruiting
One Clinical Research ( Site 2103)
Nedlands, Western Australia 6009
AustraliaActive - Recruiting
CRIO - CENTRO REGIONAL INTEGRADO DE ONCOLOGIA ( Site 2502)
Fortaleza, Ceara 60336-550
BrazilActive - Recruiting
Liga Norte Riograndense Contra o Cancer ( Site 2513)
Natal, Rio Grande Do Norte 59062-000
BrazilActive - Recruiting
Hospital Tacchini ( Site 2506)
Bento Goncalves, Rio Grande Do Sul 95700-000
BrazilActive - Recruiting
Hospital de Clínicas de Passo Fundo ( Site 2504)
Passo Fundo, Rio Grande Do Sul 99010-260
BrazilActive - Recruiting
Hospital Moinhos de Vento ( Site 2510)
Porto Alegre, Rio Grande Do Sul 90035-001
BrazilActive - Recruiting
Instituto de Oncologia Saint Gallen ( Site 2507)
Santa Cruz do Sul, Rio Grande Do Sul 96830-180
BrazilActive - Recruiting
Hospital de Amor - Barretos ( Site 2511)
Barretos, Sao Paulo 14784-400
BrazilActive - Recruiting
Queen Elizabeth II Health Sciences Centre ( Site 1101)
Halifax, Nova Scotia B3H 2Y9
CanadaActive - Recruiting
Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 1105)
Kingston, Ontario K7L 2V7
CanadaActive - Recruiting
Lakeridge Health ( Site 1107)
Oshawa, Ontario L1G 2B9
CanadaActive - Recruiting
McGill University Health Centre ( Site 1103)
Montréal, Quebec H4A 3J1
CanadaActive - Recruiting
Bradfordhill ( Site 2552)
Santiago, Region M. De Santiago 8420383
ChileActive - Recruiting
Clínica RedSalud Vitacura ( Site 2556)
Santiago, Region M. De Santiago 7650018
ChileActive - Recruiting
Orlandi Oncologia ( Site 2555)
Santiago, Region M. De Santiago 7500713
ChileActive - Recruiting
FALP ( Site 2551)
Santiago., Region M. De Santiago 7500966
ChileActive - Recruiting
ONCOCENTRO APYS ( Site 2554)
Vina del Mar, Valparaiso 2520598
ChileSite Not Available
ONCOCENTRO APYS ( Site 2554)
Vina del Mar., Valparaiso 2520598
ChileSite Not Available
ONCOCENTRO APYS ( Site 2554)
Viña del Mar, Valparaiso 2520598
ChileActive - Recruiting
IMAT S.A.S ( Site 2602)
Monteria, Cordoba 230002
ColombiaActive - Recruiting
Oncomédica S.A.S ( Site 2602)
Monteria, Cordoba 230002
ColombiaActive - Recruiting
Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia ( Site 2604)
Bogota, Distrito Capital De Bogota 111321
ColombiaActive - Recruiting
FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Sit
Bogota, Distrito Capital De Bogota 110131
ColombiaActive - Recruiting
FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 2603)
Bogota, Distrito Capital De Bogota 110131
ColombiaActive - Recruiting
Hospital Universitario San Ignacio ( Site 2610)
Bogota, Distrito Capital De Bogota 110231
ColombiaActive - Recruiting
Oncologos del Occidente ( Site 2608)
Pereira, Risaralda 660001
ColombiaActive - Recruiting
Fundacion Valle del Lili- CIC ( Site 2601)
Cali, Valle Del Cauca 760032
ColombiaActive - Recruiting
Rambam Health Care Campus ( Site 1603)
Haifa, 3109601
IsraelActive - Recruiting
Hadassah Medical Center ( Site 1605)
Jerusalem, 9112001
IsraelActive - Recruiting
Shaare Zedek Medical Center ( Site 1601)
Jerusalem, 9103102
IsraelActive - Recruiting
Sheba Medical Center ( Site 1602)
Ramat Gan, 5265601
IsraelActive - Recruiting
National Cancer Center Hospital ( Site 1156)
Chuo, Tokyo 104-0045
JapanActive - Recruiting
Tokyo Medical University Hospital ( Site 1157)
Shinjuku, Tokyo 160-0023
JapanActive - Recruiting
National Hospital Organization Kyushu Cancer Center ( Site 1167)
Fukuoka, 811-1395
JapanActive - Recruiting
Fukushima Medical University Hospital ( Site 1151)
Fukushima, 960-1295
JapanActive - Recruiting
Hiroshima University Hospital ( Site 1165)
Hiroshima, 734-8551
JapanActive - Recruiting
Wakayama Medical University Hospital ( Site 1163)
Wakayama, 641-8510
JapanActive - Recruiting
National Cancer Center ( Site 2305)
Goyang-si, Kyonggi-do 10408
Korea, Republic ofActive - Recruiting
Ajou University Hospital ( Site 2306)
Suwon, Kyonggi-do 16499
Korea, Republic ofActive - Recruiting
The Catholic University of Korea St. Vincent s Hospital ( Site 2301)
Suwonsi, Kyonggi-do 16247
Korea, Republic ofActive - Recruiting
Samsung Medical Center ( Site 2304)
Seoul, 06351
Korea, Republic ofActive - Recruiting
Seoul National University Hospital ( Site 2303)
Seoul, 03080
Korea, Republic ofActive - Recruiting
Seoul St. Mary's Hospital ( Site 2307)
Seoul, 06591
Korea, Republic ofActive - Recruiting
Severance Hospital Yonsei University Health System ( Site 2302)
Seoul, 03722
Korea, Republic ofActive - Recruiting
National Cancer Centre Singapore ( Site 2251)
Singapore, Central Singapore 168583
SingaporeActive - Recruiting
Tan Tock Seng Hospital ( Site 2252)
Singapore, Central Singapore 308433
SingaporeActive - Recruiting
China Medical University Hospital ( Site 2358)
Taichung, 40447
TaiwanActive - Recruiting
Chung Shan Medical University Hospital ( Site 2351)
Taichung, 40201
TaiwanActive - Recruiting
National Cheng Kung University Hospital ( Site 2354)
Tainan, 704
TaiwanActive - Recruiting
Koo Foundation Sun Yat-Sen Cancer Center ( Site 2359)
Taipei, 112
TaiwanActive - Recruiting
Mackay Memorial Hospital ( Site 2355)
Taipei, 104217
TaiwanActive - Recruiting
Taipei Medical University Hospital ( Site 2352)
Taipei, 11030
TaiwanActive - Recruiting
Taipei Veterans General Hospital ( Site 2357)
Taipei, 112
TaiwanActive - Recruiting
Chang Gung Memorial Hospital ( Site 2361)
Taoyuan, 333
TaiwanActive - Recruiting
Hacettepe Universite Hastaneleri ( Site 2001)
Sıhhiye, Ankara 06230
TurkeyActive - Recruiting
Namık Kemal University Medical Faculty ( Site 2007)
Tekirdag, Tekirdas 59100
TurkeyActive - Recruiting
Bristol Haematology and Oncology Centre ( Site 2072)
Bristol, Bristol, City Of BS2 8ED
United KingdomActive - Recruiting
St Bartholomews Hospital ( Site 2052)
London, London, City Of EC1A 7BE
United KingdomActive - Recruiting
Nottingham City Hospital ( Site 2058)
Nottingham, Nottinghamshire NG5 1PB
United KingdomActive - Recruiting
St James University Hospital ( Site 2055)
Leeds, LS9 7TF
United KingdomActive - Recruiting
Providence St. Jude Medical Center ( Site 0106)
Fullerton, California 92835
United StatesActive - Recruiting
UCHealth Memorial Hospital Central ( Site 0125)
Colorado Springs, Colorado 80909
United StatesActive - Recruiting
Beacon Cancer Care ( Site 0127)
Post Falls, Idaho 83854
United StatesActive - Recruiting
The University of Chicago Medical Center ( Site 0118)
Chicago, Illinois 60637
United StatesActive - Recruiting
Ellis Fischel Cancer Center ( Site 0133)
Columbia, Missouri 65212
United StatesActive - Recruiting
Lake Regional Hospital-Cancer Center ( Site 0123)
Osage Beach, Missouri 65065
United StatesActive - Recruiting
Montefiore Medical Center ( Site 0160)
Bronx, New York 10461
United StatesActive - Recruiting
Hematology-Oncology Associates of CNY ( Site 0164)
East Syracuse, New York 13057
United StatesActive - Recruiting
Icahn School of Medicine at Mount Sinai ( Site 0116)
New York, New York 10029
United StatesActive - Recruiting
Memorial Sloan Kettering Cancer Center ( Site 0137)
New York, New York 10065
United StatesActive - Recruiting
University of Cincinnati Medical Center ( Site 0119)
Cincinnati, Ohio 45219
United StatesActive - Recruiting
St. Lukes Hospital and Health Network ( Site 0186)
Bethlehem, Pennsylvania 18015
United StatesActive - Recruiting
Thompson Cancer Survival Center ( Site 0168)
Knoxville, Tennessee 37916
United StatesActive - Recruiting
MD Anderson Cancer Center ( Site 0150)
Houston, Texas 77030
United StatesActive - Recruiting
The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center (
Tyler, Texas 75701
United StatesActive - Recruiting
The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center ( Site 0148)
Tyler, Texas 75701
United StatesActive - Recruiting
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