A Study of Pembrolizumab (MK-3475) With or Without Intismeran Autogene (V940) in Participants With Non-small Cell Lung Cancer (V940-009/INTerpath-009)

Last updated: May 14, 2025
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

V940

Placebo

Intismeran autogene

Clinical Study ID

NCT06623422
V940-009
2023-506327-29
INTerpath-009
jRCT2061240105
U1111-1293-5814
  • Ages > 18
  • All Genders

Study 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).

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

Total Participants: 680
Treatment Group(s): 9
Primary Treatment: V940
Phase: 3
Study Start date:
October 21, 2024
Estimated Completion Date:
January 26, 2038

Connect with a study center

  • CEMIC ( Site 2454)

    Caba, Buenos Aires C1431FWO
    Argentina

    Site Not Available

  • CEMIC ( Site 2454)

    Caba., Buenos Aires C1431FWO
    Argentina

    Active - Recruiting

  • Fundacion Intecnus ( Site 2456)

    San Carlos de Bariloche, Rio Negro R8402APU
    Argentina

    Active - Recruiting

  • Centro Médico IPAM ( Site 2452)

    Rosario, Santa Fe S2001SBK
    Argentina

    Active - Recruiting

  • Instituto Medico Especializado Alexander Fleming ( Site 2457)

    Buenos Aires, C1426ANZ
    Argentina

    Active - Recruiting

  • Instituto Oncologico de Cordoba -IONC ( Site 2455)

    Cordoba, X5001HWE
    Argentina

    Active - Recruiting

  • Calvary Mater Newcastle ( Site 2106)

    Waratah, New South Wales 2298
    Australia

    Active - Recruiting

  • Tasman Oncology Research ( Site 2104)

    Southport, Queensland 4215
    Australia

    Active - Recruiting

  • Grampians Health ( Site 2101)

    Ballarat, Victoria 3350
    Australia

    Active - Recruiting

  • One Clinical Research ( Site 2103)

    Nedlands, Western Australia 6009
    Australia

    Active - Recruiting

  • CRIO - CENTRO REGIONAL INTEGRADO DE ONCOLOGIA ( Site 2502)

    Fortaleza, Ceara 60336-550
    Brazil

    Active - Recruiting

  • Liga Norte Riograndense Contra o Cancer ( Site 2513)

    Natal, Rio Grande Do Norte 59062-000
    Brazil

    Active - Recruiting

  • Hospital Tacchini ( Site 2506)

    Bento Goncalves, Rio Grande Do Sul 95700-000
    Brazil

    Active - Recruiting

  • Hospital de Clínicas de Passo Fundo ( Site 2504)

    Passo Fundo, Rio Grande Do Sul 99010-260
    Brazil

    Active - Recruiting

  • Hospital Moinhos de Vento ( Site 2510)

    Porto Alegre, Rio Grande Do Sul 90035-001
    Brazil

    Active - Recruiting

  • Instituto de Oncologia Saint Gallen ( Site 2507)

    Santa Cruz do Sul, Rio Grande Do Sul 96830-180
    Brazil

    Active - Recruiting

  • Hospital de Amor - Barretos ( Site 2511)

    Barretos, Sao Paulo 14784-400
    Brazil

    Active - Recruiting

  • Queen Elizabeth II Health Sciences Centre ( Site 1101)

    Halifax, Nova Scotia B3H 2Y9
    Canada

    Active - Recruiting

  • Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 1105)

    Kingston, Ontario K7L 2V7
    Canada

    Active - Recruiting

  • Lakeridge Health ( Site 1107)

    Oshawa, Ontario L1G 2B9
    Canada

    Active - Recruiting

  • McGill University Health Centre ( Site 1103)

    Montréal, Quebec H4A 3J1
    Canada

    Active - Recruiting

  • Bradfordhill ( Site 2552)

    Santiago, Region M. De Santiago 8420383
    Chile

    Active - Recruiting

  • Clínica RedSalud Vitacura ( Site 2556)

    Santiago, Region M. De Santiago 7650018
    Chile

    Active - Recruiting

  • Orlandi Oncologia ( Site 2555)

    Santiago, Region M. De Santiago 7500713
    Chile

    Active - Recruiting

  • FALP ( Site 2551)

    Santiago., Region M. De Santiago 7500966
    Chile

    Active - Recruiting

  • ONCOCENTRO APYS ( Site 2554)

    Vina del Mar, Valparaiso 2520598
    Chile

    Site Not Available

  • ONCOCENTRO APYS ( Site 2554)

    Vina del Mar., Valparaiso 2520598
    Chile

    Site Not Available

  • ONCOCENTRO APYS ( Site 2554)

    Viña del Mar, Valparaiso 2520598
    Chile

    Active - Recruiting

  • IMAT S.A.S ( Site 2602)

    Monteria, Cordoba 230002
    Colombia

    Active - Recruiting

  • Oncomédica S.A.S ( Site 2602)

    Monteria, Cordoba 230002
    Colombia

    Active - Recruiting

  • Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia ( Site 2604)

    Bogota, Distrito Capital De Bogota 111321
    Colombia

    Active - Recruiting

  • FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Sit

    Bogota, Distrito Capital De Bogota 110131
    Colombia

    Active - Recruiting

  • FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 2603)

    Bogota, Distrito Capital De Bogota 110131
    Colombia

    Active - Recruiting

  • Hospital Universitario San Ignacio ( Site 2610)

    Bogota, Distrito Capital De Bogota 110231
    Colombia

    Active - Recruiting

  • Oncologos del Occidente ( Site 2608)

    Pereira, Risaralda 660001
    Colombia

    Active - Recruiting

  • Fundacion Valle del Lili- CIC ( Site 2601)

    Cali, Valle Del Cauca 760032
    Colombia

    Active - Recruiting

  • Rambam Health Care Campus ( Site 1603)

    Haifa, 3109601
    Israel

    Active - Recruiting

  • Hadassah Medical Center ( Site 1605)

    Jerusalem, 9112001
    Israel

    Active - Recruiting

  • Shaare Zedek Medical Center ( Site 1601)

    Jerusalem, 9103102
    Israel

    Active - Recruiting

  • Sheba Medical Center ( Site 1602)

    Ramat Gan, 5265601
    Israel

    Active - Recruiting

  • National Cancer Center Hospital ( Site 1156)

    Chuo, Tokyo 104-0045
    Japan

    Active - Recruiting

  • Tokyo Medical University Hospital ( Site 1157)

    Shinjuku, Tokyo 160-0023
    Japan

    Active - Recruiting

  • National Hospital Organization Kyushu Cancer Center ( Site 1167)

    Fukuoka, 811-1395
    Japan

    Active - Recruiting

  • Fukushima Medical University Hospital ( Site 1151)

    Fukushima, 960-1295
    Japan

    Active - Recruiting

  • Hiroshima University Hospital ( Site 1165)

    Hiroshima, 734-8551
    Japan

    Active - Recruiting

  • Wakayama Medical University Hospital ( Site 1163)

    Wakayama, 641-8510
    Japan

    Active - Recruiting

  • National Cancer Center ( Site 2305)

    Goyang-si, Kyonggi-do 10408
    Korea, Republic of

    Active - Recruiting

  • Ajou University Hospital ( Site 2306)

    Suwon, Kyonggi-do 16499
    Korea, Republic of

    Active - Recruiting

  • The Catholic University of Korea St. Vincent s Hospital ( Site 2301)

    Suwonsi, Kyonggi-do 16247
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center ( Site 2304)

    Seoul, 06351
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital ( Site 2303)

    Seoul, 03080
    Korea, Republic of

    Active - Recruiting

  • Seoul St. Mary's Hospital ( Site 2307)

    Seoul, 06591
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital Yonsei University Health System ( Site 2302)

    Seoul, 03722
    Korea, Republic of

    Active - Recruiting

  • National Cancer Centre Singapore ( Site 2251)

    Singapore, Central Singapore 168583
    Singapore

    Active - Recruiting

  • Tan Tock Seng Hospital ( Site 2252)

    Singapore, Central Singapore 308433
    Singapore

    Active - Recruiting

  • China Medical University Hospital ( Site 2358)

    Taichung, 40447
    Taiwan

    Active - Recruiting

  • Chung Shan Medical University Hospital ( Site 2351)

    Taichung, 40201
    Taiwan

    Active - Recruiting

  • National Cheng Kung University Hospital ( Site 2354)

    Tainan, 704
    Taiwan

    Active - Recruiting

  • Koo Foundation Sun Yat-Sen Cancer Center ( Site 2359)

    Taipei, 112
    Taiwan

    Active - Recruiting

  • Mackay Memorial Hospital ( Site 2355)

    Taipei, 104217
    Taiwan

    Active - Recruiting

  • Taipei Medical University Hospital ( Site 2352)

    Taipei, 11030
    Taiwan

    Active - Recruiting

  • Taipei Veterans General Hospital ( Site 2357)

    Taipei, 112
    Taiwan

    Active - Recruiting

  • Chang Gung Memorial Hospital ( Site 2361)

    Taoyuan, 333
    Taiwan

    Active - Recruiting

  • Hacettepe Universite Hastaneleri ( Site 2001)

    Sıhhiye, Ankara 06230
    Turkey

    Active - Recruiting

  • Namık Kemal University Medical Faculty ( Site 2007)

    Tekirdag, Tekirdas 59100
    Turkey

    Active - Recruiting

  • Bristol Haematology and Oncology Centre ( Site 2072)

    Bristol, Bristol, City Of BS2 8ED
    United Kingdom

    Active - Recruiting

  • St Bartholomews Hospital ( Site 2052)

    London, London, City Of EC1A 7BE
    United Kingdom

    Active - Recruiting

  • Nottingham City Hospital ( Site 2058)

    Nottingham, Nottinghamshire NG5 1PB
    United Kingdom

    Active - Recruiting

  • St James University Hospital ( Site 2055)

    Leeds, LS9 7TF
    United Kingdom

    Active - Recruiting

  • Providence St. Jude Medical Center ( Site 0106)

    Fullerton, California 92835
    United States

    Active - Recruiting

  • UCHealth Memorial Hospital Central ( Site 0125)

    Colorado Springs, Colorado 80909
    United States

    Active - Recruiting

  • Beacon Cancer Care ( Site 0127)

    Post Falls, Idaho 83854
    United States

    Active - Recruiting

  • The University of Chicago Medical Center ( Site 0118)

    Chicago, Illinois 60637
    United States

    Active - Recruiting

  • Ellis Fischel Cancer Center ( Site 0133)

    Columbia, Missouri 65212
    United States

    Active - Recruiting

  • Lake Regional Hospital-Cancer Center ( Site 0123)

    Osage Beach, Missouri 65065
    United States

    Active - Recruiting

  • Montefiore Medical Center ( Site 0160)

    Bronx, New York 10461
    United States

    Active - Recruiting

  • Hematology-Oncology Associates of CNY ( Site 0164)

    East Syracuse, New York 13057
    United States

    Active - Recruiting

  • Icahn School of Medicine at Mount Sinai ( Site 0116)

    New York, New York 10029
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center ( Site 0137)

    New York, New York 10065
    United States

    Active - Recruiting

  • University of Cincinnati Medical Center ( Site 0119)

    Cincinnati, Ohio 45219
    United States

    Active - Recruiting

  • St. Lukes Hospital and Health Network ( Site 0186)

    Bethlehem, Pennsylvania 18015
    United States

    Active - Recruiting

  • Thompson Cancer Survival Center ( Site 0168)

    Knoxville, Tennessee 37916
    United States

    Active - Recruiting

  • MD Anderson Cancer Center ( Site 0150)

    Houston, Texas 77030
    United States

    Active - Recruiting

  • The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center (

    Tyler, Texas 75701
    United States

    Active - Recruiting

  • The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center ( Site 0148)

    Tyler, Texas 75701
    United States

    Active - Recruiting

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