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A Study of Pembrolizumab (MK-3475) With or Without Intismeran Autogene (V940) in Participants With Non-small Cell Lung Cancer (V940-009/INTerpath-009)
Sponsor: Merck Sharp & Dohme LLC
Summary
The goal of this study is to learn if people who receive intismeran autogene and pembrolizumab after surgery are cancer-free longer than people who receive placebo and pembrolizumab. Researchers want to know if giving intismeran autogene and pembrolizumab after surgery can help prevent the cancer from coming back in people with non-small cell lung cancer (NSCLC) whose tumors did not respond completely to treatment before surgery (neoadjuvant treatment).
Official title: A Phase 3 Randomized Double-blind Study of Adjuvant Pembrolizumab With or Without V940 in Participants With Resectable Stage II to IIIB (N2) NSCLC Not Achieving pCR After Receiving Neoadjuvant Pembrolizumab With Platinum-based Doublet Chemotherapy (INTerpath-009)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
680
Start Date
2024-10-21
Completion Date
2038-01-26
Last Updated
2026-10-30
Healthy Volunteers
No
Conditions
Interventions
Pembrolizumab
IV Infusion
Cisplatin
IV infusion
Carboplatin
IV infusion
Pemetrexed
IV infusion
Gemcitabine
IV infusion
Paclitaxel
IV infusion
Intismeran autogene
IM injection
Placebo
IM injection
Locations (245)
Banner MD Anderson Cancer Center ( Site 0181)
Gilbert, Arizona, United States
The University of Arizona Cancer Center - North Campus ( Site 0163)
Tucson, Arizona, United States
Providence St. Jude Medical Center ( Site 0106)
Fullerton, California, United States
VA Long Beach Healthcare System ( Site 0199)
Long Beach, California, United States
USC Norris Comprehensive Cancer Center ( Site 0205)
Los Angeles, California, United States
UCLA Jonsson Comprehensive Cancer Center ( Site 0135)
Los Angeles, California, United States
UCSF Medical Center at Mission Bay ( Site 0178)
San Francisco, California, United States
University of Colorado Anschutz Medical Campus ( Site 0151)
Aurora, Colorado, United States
UCHealth Memorial Hospital Central ( Site 0125)
Colorado Springs, Colorado, United States
Banner MD Anderson Cancer Center at North Colorado Medical Center ( Site 0207)
Greeley, Colorado, United States
Centura Health - St. Anthony North Health Campus ( Site 0189)
Westminster, Colorado, United States
Yale University School of Medicine ( Site 0201)
New Haven, Connecticut, United States
Eastern CT Hematology & Oncology Associates ( Site 0202)
Norwich, Connecticut, United States
The Oncology Institute of Hope and Innovation - Fort Lauderdale ( Site 0156)
Fort Lauderdale, Florida, United States
Miami Cancer Institute at Baptist Health, Inc. ( Site 0214)
Miami, Florida, United States
Beacon Cancer Care ( Site 0127)
Post Falls, Idaho, United States
The University of Chicago Medical Center ( Site 0118)
Chicago, Illinois, United States
Illinois Cancer Care ( Site 8107)
Peoria, Illinois, United States
Franciscan Health ( Site 0219)
Indianapolis, Indiana, United States
Maryland Oncology Hematology (MOH) ( Site 8102)
Rockville, Maryland, United States
Massachusetts General Hospital ( Site 0136)
Boston, Massachusetts, United States
Dana Farber Cancer Hospital ( Site 0155)
Boston, Massachusetts, United States
Ellis Fischel Cancer Center ( Site 0133)
Columbia, Missouri, United States
Lake Regional Hospital-Cancer Center ( Site 0123)
Osage Beach, Missouri, United States
Roswell Park Cancer Institute ( Site 0184)
Buffalo, New York, United States
Hematology-Oncology Associates of CNY ( Site 0164)
East Syracuse, New York, United States
The Blavatnik Family- Chelsea Medical Center at Mount Sinai ( Site 0216)
New York, New York, United States
Icahn School of Medicine at Mount Sinai ( Site 0116)
New York, New York, United States
Memorial Sloan Kettering Cancer Center ( Site 0137)
New York, New York, United States
SUNY Upstate Cancer Center ( Site 0140)
Syracuse, New York, United States
Montefiore Medical Center ( Site 0160)
The Bronx, New York, United States
Westchester Medical Center ( Site 0196)
Valhalla, New York, United States
Novant Health Weisiger Cancer Insititute ( Site 0266)
Charlotte, North Carolina, United States
Novant Health Forsyth Medical Center ( Site 0166)
Winston-Salem, North Carolina, United States
University of Cincinnati Medical Center ( Site 0119)
Cincinnati, Ohio, United States
Good Samaritan Regional Medical Center-Samaritan Pastega Regional Cancer Center ( Site 0217)
Corvallis, Oregon, United States
St. Lukes Hospital and Health Network ( Site 0186)
Bethlehem, Pennsylvania, United States
Tennessee Oncology, PLLC - Chattanooga Downtown ( Site 0315)
Chattanooga, Tennessee, United States
Thompson Cancer Survival Center ( Site 0168)
Knoxville, Tennessee, United States
Baptist Clinical Research Institute, Inc. ( Site 9501)
Memphis, Tennessee, United States
Elliston Place Medical Oncology & Hematology ( Site 0215)
Nashville, Tennessee, United States
Texas Oncology - DFW ( Site 8103)
Dallas, Texas, United States
UT Southwestern Medical Center ( Site 0190)
Dallas, Texas, United States
Houston Methodist Cancer Center ( Site 0191)
Houston, Texas, United States
MD Anderson Cancer Center ( Site 0150)
Houston, Texas, United States
Memorial Hermann Cancer Center ( Site 0172)
Houston, Texas, United States
Michael E. DeBakey VA Medical Center ( Site 0197)
Houston, Texas, United States
O'Quinn Medical Tower at McNair Campus ( Site 0131)
Houston, Texas, United States
The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center ( Site 0148)
Tyler, Texas, United States
Virginia Cancer Specialists ( Site 0167)
Fairfax, Virginia, United States
Virginia Oncology Associates (VOA) ( Site 8101)
Norfolk, Virginia, United States
VCU Health Adult Outpatient Pavillion ( Site 0193)
Richmond, Virginia, United States
Swedish Cancer Institute ( Site 0143)
Seattle, Washington, United States
St. Joseph Medical Center Hematology and Oncology - Silverdale ( Site 0192)
Silverdale, Washington, United States
CEMIC ( Site 2454)
Caba., Buenos Aires, Argentina
Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 2459)
Ciudad Autonoma de Buenos Aires., Buenos Aires, Argentina
Fundacion Intecnus ( Site 2456)
Bariloche, Río Negro Province, Argentina
Centro Médico IPAM ( Site 2452)
Rosario, Santa Fe Province, Argentina
Instituto Medico Especializado Alexander Fleming ( Site 2457)
Buenos Aires, Argentina
Instituto Oncologico de Cordoba -IONC ( Site 2455)
Córdoba, Argentina
Calvary Mater Newcastle ( Site 2106)
Waratah, New South Wales, Australia
Tasman Oncology Research ( Site 2104)
Southport, Queensland, Australia
Princess Alexandra Hospital ( Site 2102)
Woolloongabba, Queensland, Australia
Grampians Health ( Site 2101)
Ballarat, Victoria, Australia
One Clinical Research ( Site 2103)
Nedlands, Western Australia, Australia
Cliniques Universitaires Saint-Luc ( Site 1203)
Brussels, Bruxelles-Capitale, Region de, Belgium
Jessa Ziekenhuis ( Site 1204)
Hasselt, Limburg, Belgium
UZ Gent ( Site 1201)
Ghent, Oost-Vlaanderen, Belgium
CRIO - CENTRO REGIONAL INTEGRADO DE ONCOLOGIA ( Site 2502)
Fortaleza, Ceará, Brazil
Hospital Araújo Jorge ( Site 2514)
Goiânia, Goiás, Brazil
Liga Norte Riograndense Contra o Cancer ( Site 2513)
Natal, Rio Grande do Norte, Brazil
Hospital Tacchini ( Site 2506)
Bento Gonçalves, Rio Grande do Sul, Brazil
Hospital de Clínicas de Passo Fundo ( Site 2504)
Passo Fundo, Rio Grande do Sul, Brazil
Hospital Moinhos de Vento ( Site 2510)
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Nossa Senhora Da Conceicao ( Site 2512)
Porto Alegre, Rio Grande do Sul, Brazil
Instituto de Oncologia Saint Gallen ( Site 2507)
Santa Cruz do Sul, Rio Grande do Sul, Brazil
Hospital de Amor - Barretos ( Site 2511)
Barretos, São Paulo, Brazil
Instituto Nacional de Câncer - INCA ( Site 2501)
Rio de Janeiro, Brazil
MBAL Uni Hospital ( Site 1253)
Panagyurishte, Pazardzhik, Bulgaria
MHAT - Heart and Brain ( Site 1252)
Pleven, Bulgaria
Queen Elizabeth II Health Sciences Centre ( Site 1101)
Halifax, Nova Scotia, Canada
Hamilton Health Sciences - Juravinski Site ( Site 1104)
Hamilton, Ontario, Canada
Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 1105)
Kingston, Ontario, Canada
Lakeridge Health ( Site 1107)
Oshawa, Ontario, Canada
Sunnybrook Research Institute ( Site 1106)
Toronto, Ontario, Canada
McGill University Health Centre ( Site 1103)
Montreal, Quebec, Canada
IUCPQ ( Site 1112)
Québec, Quebec, Canada
Orlandi Oncologia ( Site 2555)
Santiago, Region M. de Santiago, Chile
Fundación Arturo López Pérez ( Site 2551)
Santiago, Region M. de Santiago, Chile
Clínica RedSalud Vitacura ( Site 2556)
Santiago, Region M. de Santiago, Chile
Bradfordhill ( Site 2552)
Santiago, Region M. de Santiago, Chile
ONCOCENTRO APYS ( Site 2554)
Viña del Mar, Valparaiso, Chile
Bradford Hill Norte ( Site 2563)
Antofagasta, Chile
FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 2603)
Bogotá, Bogota D.C., Colombia
Hospital Universitario San Ignacio ( Site 2610)
Bogotá, Bogota D.C., Colombia
Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia ( Site 2604)
Bogotá, Bogota D.C., Colombia
IMAT S.A.S ( Site 2602)
Montería, Departamento de Córdoba, Colombia
Oncologos del Occidente ( Site 2608)
Pereira, Risaralda Department, Colombia
Fundacion Valle del Lili- CIC ( Site 2601)
Cali, Valle del Cauca Department, Colombia
Oulun yliopistollinen sairaala ( Site 1301)
Oulu, Northern Savonia, Finland