Clinical trial NCT06623422: A Study of Pembrolizumab (MK-3475) With or Without Intismeran Autogene (V940) in Participants With Non-small Cell Lung Cancer (V940-009/INTerpath-009)
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Programmed Cell Death-1 (PD1, PD-1)
Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1)
Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)
Individualized neoantigen therapy (INT)
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
Collaborators: name: ModernaTX, Inc.
First posted: 2024-10-02
Enrollment: 680
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 Criteria:

The main inclusion criteria include but are not limited to the following:

* Has histologically/cytologically confirmed diagnosis of previously untreated and pathologically confirmed resectable Stage II, IIIA, or IIIB (N2) non-small cell lung cancer (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) following completion of neoadjuvant chemotherapy and pembrolizumab followed by surgery will be eligible
* Confirmation that epidermal growth factor receptor (EGFR)-directed therapy is not indicated as primary therapy (documentation of absence of tumor-activating EGFR mutations \[eg, DEL19 or L858R\])
* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART)
* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization
* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening

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 a neuroendocrine tumor with large-cell components, or a sarcomatoid carcinoma, or a pancoast 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-programmed cell 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 other than 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 has radiation-related toxicities, requiring corticosteroids
* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention

Primary outcomes:
measure: Disease-Free Survival (DFS)
timeFrame: Up to ~97 months
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to ~129 months
measure: Distant Metastasis-Free Survival (DMFS)
timeFrame: Up to ~129 months
measure: Disease-Free Survival 2 (DFS2)
timeFrame: Up to ~129 months
measure: Lung Cancer Specific Survival (LCSS)
timeFrame: Up to ~129 months
measure: Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30)
timeFrame: Baseline and up to ~129 months
measure: Change from Baseline in the EORTC QLQ-C30 Physical Functioning (Items 1-5)
timeFrame: Baseline and up to ~129 months
measure: Change from Baseline in the EORTC QLQ-C30 Role Functioning (Items 6 and 7)
timeFrame: Baseline and up to ~129 months
measure: Number of participants with ≥1 adverse event (AE)
timeFrame: Up to ~129 months
measure: Number of participants discontinuing from study therapy due to AE(s)
timeFrame: Up to ~129 months
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Banner MD Anderson Cancer Center ( Site 0181)
state: Arizona
city: Fullerton
country: United States
facility: Providence St. Jude Medical Center ( Site 0106)
state: California
city: San Francisco
country: United States
facility: UCSF Medical Center at Mission Bay ( Site 0178)
state: California
city: Colorado Springs
country: United States
facility: UCHealth Memorial Hospital Central ( Site 0125)
state: Colorado
city: Greeley
country: United States
facility: Banner MD Anderson Cancer Center at North Colorado Medical Center ( Site 0207)
state: Colorado
city: Post Falls
country: United States
facility: Beacon Cancer Care ( Site 0127)
state: Idaho
city: Chicago
country: United States
facility: The University of Chicago Medical Center ( Site 0118)
state: Illinois
city: Boston
country: United States
facility: Massachusetts General Hospital ( Site 0136)
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Hospital ( Site 0155)
state: Massachusetts
city: Columbia
country: United States
facility: Ellis Fischel Cancer Center ( Site 0133)
state: Missouri
city: Osage Beach
country: United States
facility: Lake Regional Hospital-Cancer Center ( Site 0123)
state: Missouri
city: Bronx
country: United States
facility: Montefiore Medical Center ( Site 0160)
state: New York
city: East Syracuse
country: United States
facility: Hematology-Oncology Associates of CNY ( Site 0164)
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai ( Site 0116)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center ( Site 0137)
state: New York
city: Valhalla
country: United States
facility: Westchester Medical Center ( Site 0196)
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center ( Site 0119)
state: Ohio
city: Bethlehem
country: United States
facility: St. Lukes Hospital and Health Network ( Site 0186)
state: Pennsylvania
city: Knoxville
country: United States
facility: Thompson Cancer Survival Center ( Site 0168)
state: Tennessee
city: Houston
country: United States
facility: MD Anderson Cancer Center ( Site 0150)
state: Texas
city: Tyler
country: United States
facility: The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center ( Site 0148)
state: Texas
city: Seattle
country: United States
facility: Swedish Cancer Institute ( Site 0143)
state: Washington
city: Caba.
country: Argentina
facility: CEMIC ( Site 2454)
state: Buenos Aires
city: San Carlos de Bariloche
country: Argentina
facility: Fundacion Intecnus ( Site 2456)
state: Rio Negro
city: Rosario
country: Argentina
facility: Centro Médico IPAM ( Site 2452)
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Instituto Medico Especializado Alexander Fleming ( Site 2457)
city: Cordoba
country: Argentina
facility: Instituto Oncologico de Cordoba -IONC ( Site 2455)
city: Waratah
country: Australia
facility: Calvary Mater Newcastle ( Site 2106)
state: New South Wales
city: Southport
country: Australia
facility: Tasman Oncology Research ( Site 2104)
state: Queensland
city: Wooloongabba
country: Australia
facility: Princess Alexandra Hospital ( Site 2102)
state: Queensland
city: Ballarat
country: Australia
facility: Grampians Health ( Site 2101)
state: Victoria
city: Nedlands
country: Australia
facility: One Clinical Research ( Site 2103)
state: Western Australia
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint-Luc ( Site 1203)
state: Bruxelles-Capitale, Region De
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis ( Site 1204)
state: Limburg
city: Gent
country: Belgium
facility: UZ Gent ( Site 1201)
state: Oost-Vlaanderen
city: Fortaleza
country: Brazil
facility: CRIO - CENTRO REGIONAL INTEGRADO DE ONCOLOGIA ( Site 2502)
state: Ceara
city: Natal
country: Brazil
facility: Liga Norte Riograndense Contra o Cancer ( Site 2513)
state: Rio Grande Do Norte
city: Bento Goncalves
country: Brazil
facility: Hospital Tacchini ( Site 2506)
state: Rio Grande Do Sul
city: Passo Fundo
country: Brazil
facility: Hospital de Clínicas de Passo Fundo ( Site 2504)
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital Moinhos de Vento ( Site 2510)
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital Nossa Senhora Da Conceicao ( Site 2512)
state: Rio Grande Do Sul
city: Santa Cruz do Sul
country: Brazil
facility: Instituto de Oncologia Saint Gallen ( Site 2507)
state: Rio Grande Do Sul
city: Barretos
country: Brazil
facility: Hospital de Amor - Barretos ( Site 2511)
state: Sao Paulo
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional de Câncer - INCA ( Site 2501)
city: Pleven
country: Bulgaria
facility: MHAT - Heart and Brain ( Site 1252)
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre ( Site 1101)
state: Nova Scotia
city: Kingston
country: Canada
facility: Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 1105)
state: Ontario
city: Oshawa
country: Canada
facility: Lakeridge Health ( Site 1107)
state: Ontario
city: Montréal
country: Canada
facility: McGill University Health Centre ( Site 1103)
state: Quebec
city: Québec
country: Canada
facility: IUCPQ ( Site 1112)
state: Quebec
city: Santiago.
country: Chile
facility: FALP ( Site 2551)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Orlandi Oncologia ( Site 2555)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Clínica RedSalud Vitacura ( Site 2556)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Bradfordhill ( Site 2552)
state: Region M. De Santiago
city: Viña del Mar
country: Chile
facility: ONCOCENTRO APYS ( Site 2554)
state: Valparaiso
city: Monteria
country: Colombia
facility: IMAT S.A.S ( Site 2602)
state: Cordoba
city: Bogota
country: Colombia
facility: FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 2603)
state: Distrito Capital De Bogota
city: Bogota
country: Colombia
facility: Hospital Universitario San Ignacio ( Site 2610)
state: Distrito Capital De Bogota
city: Bogota
country: Colombia
facility: Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia ( Site 2604)
state: Distrito Capital De Bogota
city: Pereira
country: Colombia
facility: Oncologos del Occidente ( Site 2608)
state: Risaralda
city: Cali
country: Colombia
facility: Fundacion Valle del Lili- CIC ( Site 2601)
state: Valle Del Cauca
city: Oulu
country: Finland
facility: Oulun yliopistollinen sairaala ( Site 1301)
state: Pohjois-Pohjanmaa
city: Turku
country: Finland
facility: Turku University Hospital ( Site 1303)
state: Varsinais-Suomi
city: Saint Herblain
country: France
facility: Institut De Cancerologie De L Ouest ( Site 1357)
state: Loire-Atlantique
city: Mainz
country: Germany
facility: Marienhaus Klinikum Mainz ( Site 1403)
state: Rheinland-Pfalz
city: Athens
country: Greece
facility: Errikos Dunant Hospital Center ( Site 1457)
state: Attiki
city: Athens
country: Greece
facility: THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA"-3rd Dept of Internal Medicine and Laboratory, Oncol ( Site 1451)
state: Attiki
city: Herakleion.
country: Greece
facility: University General Hospital of Herakleion ( Site 1458)
state: Irakleio
city: Larissa
country: Greece
facility: University General Hospital of Larissa-Oncology Clinic ( Site 1453)
state: Thessalia
city: Thessaloniki
country: Greece
facility: Papageorgiou General Hospital of Thessaloniki ( Site 1454)
city: Gyor
country: Hungary
facility: Petz Aladár Megyei Oktató Kórház ( Site 1502)
state: Gyor-Moson-Sopron
city: Mátraháza
country: Hungary
facility: Mátrai Gyógyintézet ( Site 1504)
state: Heves
city: Törökbálint
country: Hungary
facility: Reformatus Pulmonologiai Centrum-Onkopulmonologiai Jarobeteg Centrum ( Site 1505)
state: Pest
city: Kaposvár
country: Hungary
facility: Somogy Vármegyei Kaposi Mór Oktató Kórház-Oncology center ( Site 1507)
state: Somogy
city: Haifa
country: Israel
facility: Rambam Health Care Campus ( Site 1603)
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center ( Site 1601)
city: Jerusalem
country: Israel
facility: Hadassah Medical Center ( Site 1605)
city: Ramat Gan
country: Israel
facility: Sheba Medical Center ( Site 1602)
city: Kitakyushu
country: Japan
facility: Hospital of the University of Occupational and Environmental Health, Japan ( Site 1166)
state: Fukuoka
city: Kawasaki
country: Japan
facility: St. Marianna University Hospital ( Site 1159)
state: Kanagawa
city: Chuo
country: Japan
facility: National Cancer Center Hospital ( Site 1156)
state: Tokyo
city: Shinjuku
country: Japan
facility: Tokyo Medical University Hospital ( Site 1157)
state: Tokyo
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Cancer Center ( Site 1167)
city: Fukushima
country: Japan
facility: Fukushima Medical University Hospital ( Site 1151)
city: Hiroshima
country: Japan
facility: Hiroshima University Hospital ( Site 1165)
city: Wakayama
country: Japan
facility: Wakayama Medical University Hospital ( Site 1163)
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center ( Site 2305)
state: Kyonggi-do
city: Suwonsi
country: Korea, Republic of
facility: The Catholic University of Korea St. Vincent s Hospital ( Site 2301)
state: Kyonggi-do
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital ( Site 2306)
state: Kyonggi-do
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital ( Site 2303)
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System ( Site 2302)
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center ( Site 2304)
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital ( Site 2307)
city: Nijmegen
country: Netherlands
facility: Radboudumc ( Site 1706)
state: Gelderland
city: Dunedin
country: New Zealand
facility: Dunedin Hospital ( Site 2202)
state: Otago
city: Krakow
country: Poland
facility: Krakowski Szpital Specjalistyczny im. Jana Pawla II ( Site 1756)
state: Malopolskie
city: Przemysl
country: Poland
facility: Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1759)
state: Podkarpackie
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne ( Site 1758)
state: Pomorskie
city: Kielce
country: Poland
facility: Swietokrzyskie Centrum Onkologii. ( Site 1754)
state: Swietokrzyskie
city: Olsztyn
country: Poland
facility: Warmińsko - Mazurskie Centrum Chorób Płuc w Olsztynie ( Site 1760)
state: Warminsko-mazurskie
city: Poznan
country: Poland
facility: Wielkopolskie Centrum Pulmonologii i Torakochirurgii ( Site 1763)
state: Wielkopolskie
city: Iasi
country: Romania
facility: Institutul Regional de Oncologie ( Site 1804)
city: Singapore
country: Singapore
facility: National Cancer Centre Singapore ( Site 2251)
state: Central Singapore
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital ( Site 2252)
state: Central Singapore
city: A Coruña
country: Spain
facility: Complejo Hospitalario Universitario A Coruna ( Site 1916)
state: La Coruna
city: Pozuelo de Alarcon
country: Spain
facility: Hospital Universitario Quiron Madrid ( Site 1913)
state: Madrid
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon ( Site 1912)
city: Malaga
country: Spain
facility: Hospital Quiron Malaga ( Site 1914)
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset Solna ( Site 1951)
state: Stockholms Lan
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital ( Site 2351)
city: Taichung
country: Taiwan
facility: China Medical University Hospital ( Site 2358)
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital ( Site 2354)
city: Taipei
country: Taiwan
facility: National Taiwan University Cancer Center (NTUCC) ( Site 2360)
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital ( Site 2355)
city: Taipei
country: Taiwan
facility: Taipei Medical University Hospital ( Site 2352)
city: Taipei
country: Taiwan
facility: Koo Foundation Sun Yat-Sen Cancer Center ( Site 2359)
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital ( Site 2357)
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital ( Site 2361)
city: Sıhhiye
country: Turkey
facility: Hacettepe Universite Hastaneleri ( Site 2001)
state: Ankara
city: Tekirdag
country: Turkey
facility: Namık Kemal University Medical Faculty ( Site 2007)
state: Tekirdas
city: Bristol
country: United Kingdom
facility: Bristol Haematology and Oncology Centre ( Site 2072)
state: Bristol, City Of
city: London
country: United Kingdom
facility: St Bartholomews Hospital ( Site 2052)
state: London, City Of
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital ( Site 2058)
state: Nottinghamshire
city: Leeds
country: United Kingdom
facility: St James University Hospital ( Site 2055)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: