Clinical trial NCT06077760: A Study of Intismeran Autogene (V940) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Non-small Cell Lung Cancer (V940-002)
Official title: A Phase 3, Randomized, Double-blind, Placebo- and Active-Comparator-Controlled Clinical Study of Adjuvant V940 (mRNA-4157) Plus Pembrolizumab Versus Adjuvant Placebo Plus Pembrolizumab in Participants With Resected Stage II, IIIA, IIIB (N2) Non-small Cell Lung Cancer (INTerpath-002)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Non-small Cell Lung Cancer
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
Collaborators: name: ModernaTX, Inc.
First posted: 2023-10-11
Enrollment: 868
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 evaluate intismeran autogene plus pembrolizumab versus placebo plus pembrolizumab for the adjuvant treatment of margin negative, completely resected Stage II, IIIA, IIIB (with nodal involvement \[N2\]) non-small cell lung cancer (NSCLC). The primary hypothesis is that intismeran autogene plus pembrolizumab is superior to placebo plus pembrolizumab with respect to disease-free survival (DFS) as assessed by the investigator.


Eligibility criteria: Inclusion Criteria:

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

* Has undergone margin negative, completely resected non-small cell lung cancer (NSCLC), and has pathological Stage II, IIIA, IIIB (N2) squamous or nonsquamous tumor, node, metastasis (TNM) staging per American Joint Committee on Cancer (AJCC) Eighth Edition guidelines.
* Has no evidence of disease before randomization.
* Has received at least one dose of adjuvant treatment with standard of care platinum doublet chemotherapy.
* No more than 24 weeks have elapsed between surgical resection of curative intent and the first dose of pembrolizumab.
* 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.
* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART).

Exclusion Criteria:

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

* Diagnosis of small cell lung cancer (SCLC) or, for mixed tumors, presence of small cell elements, or has a neuroendocrine tumor with large cell components or a sarcomatoid carcinoma.
* HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
* Received prior neoadjuvant therapy for their current NSCLC diagnosis.
* Received or is a candidate to receive radiotherapy for their current NSCLC diagnosis.
* Received prior therapy with an anti-programmed cell death 1 protein (PD-1), anti-PD-ligand 1 (L1), or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor.
* Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
* Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.
* Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication.
* Known additional malignancy that is progressing or has required active treatment within the past 5 years.
* Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed.
* History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
* Active infection requiring systemic therapy.

Primary outcomes:
measure: Disease- Free Survival (DFS)
timeFrame: Up to ~78 months
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to ~12 years
measure: Distant Metastasis-Free Survival (DMFS)
timeFrame: Up to ~12 years
measure: Lung Cancer Specific Survival (LCSS)
timeFrame: Up to ~12 years
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) Combined Score
timeFrame: Baseline and up to ~12 years
measure: Change from Baseline in the EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30
timeFrame: Baseline and up to ~12 years
measure: Change from Baseline in the EORTC QLQ-C30 Role Functioning (Items 6 and 7) Combined Score on the EORTC QLQ-C30
timeFrame: Baseline and up to ~12 years
measure: Change from Baseline in the EORTC QLQ-C30 Dyspnea (Item 8) Score on the EORTC QLQ-C30
timeFrame: Baseline and up to ~12 years
measure: Change from Baseline in the EORTC QLQ-Lung Cancer Questionnaire (LC24) Coughing (Items 31 and 52) Combined Score on the EORTC QLQ-LC24
timeFrame: Baseline and up to ~12 years
measure: Change from Baseline in the EORTC QLQ-LC24 Chest Pain (Item 40) Score on the EORTC QLQ-LC24
timeFrame: Baseline and up to ~12 years
measure: Number of Participants Who Experience an Adverse Event (AE)
timeFrame: Up to ~15 months
measure: Number of Participants Who Discontinue Study Treatment Due to an AE
timeFrame: Up to ~12 months
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Alaska Oncology and Hematology ( Site 0039)
state: Alaska
city: Yuma
country: United States
facility: YUMA REGIONAL MEDICAL CENTER CANCER CENTER ( Site 0020)
state: Arizona
city: Los Angeles
country: United States
facility: UCLA Clinical & Translational Research Center (CTRC) ( Site 0059)
state: California
city: Orange
country: United States
facility: St. Joseph Hospital-The Center for Cancer Prevention and Treatment ( Site 0074)
state: California
city: Orange
country: United States
facility: University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 0030)
state: California
city: Colorado Springs
country: United States
facility: UCHealth Memorial Hospital-Heme Onc ( Site 0052)
state: Colorado
city: Orange City
country: United States
facility: Mid Florida Hematology and Oncology Center ( Site 0014)
state: Florida
city: Orlando
country: United States
facility: AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlandoc ( Site 0013)
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center ( Site 0078)
state: Florida
city: Marietta
country: United States
facility: Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0012)
state: Georgia
city: Newnan
country: United States
facility: Southeastern Regional Medical Center ( Site 0098)
state: Georgia
city: Post Falls
country: United States
facility: Beacon Cancer Care ( Site 0044)
state: Idaho
city: Iowa City
country: United States
facility: University of Iowa-Holden Comprehensive Cancer Center ( Site 0062)
state: Iowa
city: Edgewood
country: United States
facility: Saint Elizabeth Healthcare ( Site 0092)
state: Kentucky
city: Louisville
country: United States
facility: The University of Louisville, James Graham Brown Cancer Center ( Site 0037)
state: Kentucky
city: Ann Arbor
country: United States
facility: University of Michigan Clinical Trials Office ( Site 0058)
state: Michigan
city: Grand Rapids
country: United States
facility: Cancer and Hematology Centers of Western Michigan ( Site 4003)
state: Michigan
city: Billings
country: United States
facility: St. Vincent Frontier Cancer Center ( Site 0043)
state: Montana
city: Lincoln
country: United States
facility: NHO Revive Research Institute, LLC ( Site 4009)
state: Nebraska
city: Hackensack
country: United States
facility: John Theurer Cancer Center at Hackensack University Medical Center ( Site 0036)
state: New Jersey
city: Albany
country: United States
facility: New York Oncology Hematology, P.C. ( Site 4012)
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center- Montefiore Medical Park-Oncology ( Site 0080)
state: New York
city: Mineola
country: United States
facility: Perlmutter Cancer Center at NYU Langone Hospital - Long Island-Clinical Research Department ( Site 0095)
state: New York
city: New York
country: United States
facility: Laura and Isaac Perlmutter Cancer Center ( Site 0010)
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai ( Site 0034)
state: New York
city: New York
country: United States
facility: Columbia University Irving Medical Center-CUIMC Herbert Irving Comprehensive Cancer Center Clinical ( Site 0054)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center ( Site 0029)
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University-Cancer Center ( Site 0072)
state: New York
city: Fargo
country: United States
facility: Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 0063)
state: North Dakota
city: Grand Forks
country: United States
facility: Altru Health System ( Site 0040)
state: North Dakota
city: Akron
country: United States
facility: Summa Health ( Site 4011)
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 0028)
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center ( Site 0023)
state: Ohio
city: Columbus
country: United States
facility: OSU Brain and Spine Hospital ( Site 0016)
state: Ohio
city: Corvallis
country: United States
facility: Good Samaritan Regional Medical Center-Samaritan Pastega Regional Cancer Center ( Site 0082)
state: Oregon
city: Philadelphia
country: United States
facility: Thomas Jefferson University - Clinical Research Institute ( Site 0006)
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina-Hollings Cancer Center ( Site 0050)
state: South Carolina
city: Sioux Falls
country: United States
facility: Sanford Cancer Center ( Site 0075)
state: South Dakota
city: Knoxville
country: United States
facility: Thompson Cancer Survival Center ( Site 0097)
state: Tennessee
city: Nashville
country: United States
facility: One Oncology - Tennessee Oncology ( Site 4019)
state: Tennessee
city: Nashville
country: United States
facility: SCRI Oncology Partners ( Site 7001)
state: Tennessee
city: Dallas
country: United States
facility: UT Southwestern Medical Center ( Site 0061)
state: Texas
city: Fairfax
country: United States
facility: Inova Schar Cancer Institute ( Site 0003)
state: Virginia
city: Seattle
country: United States
facility: Swedish Medical Center-Swedish Cancer Institute ( Site 0088)
state: Washington
city: Huntington
country: United States
facility: Edwards Comprehensive Cancer Center ( Site 4015)
state: West Virginia
city: Caba.
country: Argentina
facility: Clinica Adventista Belgrano-Oncology ( Site 2901)
state: Buenos Aires
city: Caba
country: Argentina
facility: Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 2912)
state: Buenos Aires
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Instituto Alexander Fleming ( Site 2911)
state: Buenos Aires
city: Mar del Plata
country: Argentina
facility: Instituto de Investigaciones Clínicas Mar del Plata ( Site 2908)
state: Buenos Aires
city: Rosario
country: Argentina
facility: Fundacion Estudios Clinicos-Oncology ( Site 2907)
state: Santa Fe
city: Rosario
country: Argentina
facility: Sanatorio Parque ( Site 2904)
state: Santa Fe
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 0203)
state: Victoria
city: Melbourne
country: Australia
facility: St Vincent's Hospital-Oncology Clinical Trials ( Site 0202)
state: Victoria
city: Nedlands
country: Australia
facility: One Clinical Research ( Site 0200)
state: Western Australia
city: Edegem
country: Belgium
facility: Antwerp University Hospital-Thoracic Oncology ( Site 0603)
state: Antwerpen
city: Yvoir
country: Belgium
facility: Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godi ( Site 0602)
state: Namur
city: Aalst
country: Belgium
facility: AZORG Campus Aalst-Moorselbaan ( Site 0604)
state: Oost-Vlaanderen
city: Sint-Niklaas
country: Belgium
facility: VITAZ ( Site 0600)
state: Oost-Vlaanderen
city: Fortaleza
country: Brazil
facility: CRIO - CENTRO REGIONAL INTEGRADO DE ONCOLOGIA-Pesquisa Clínica ( Site 3007)
state: Ceara
city: Natal.
country: Brazil
facility: Liga Norte Riograndense Contra o Câncer ( Site 3001)
state: Rio Grande Do Norte
city: Porto Alegre
country: Brazil
facility: Irmandade da Santa Casa de Misericórdia de Porto Alegre ( Site 3003)
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital Nossa Senhora da Conceição ( Site 3002)
state: Rio Grande Do Sul
city: Barretos
country: Brazil
facility: Fundação Pio XII - Hospital de Câncer de Barretos ( Site 3004)
state: Sao Paulo
city: São José do Rio Preto
country: Brazil
facility: Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 3013)
state: Sao Paulo
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional de Câncer - INCA ( Site 3000)
city: Sao Paulo
country: Brazil
facility: Hospital Samaritano De Sao Paulo ( Site 3006)
city: Sao Paulo
country: Brazil
facility: ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 3005)
city: Edmonton
country: Canada
facility: Cross Cancer Institute ( Site 0105)
state: Alberta
city: Brampton
country: Canada
facility: William Osler Health System ( Site 0101)
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre ( Site 0102)
state: Ontario
city: Montréal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal ( Site 0104)
state: Quebec
city: Montréal
country: Canada
facility: McGill University Health Centre ( Site 0100)
state: Quebec
city: Santiago
country: Chile
facility: Orlandi Oncologia-Oncology ( Site 3102)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: FALP-UIDO ( Site 3100)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Pontificia Universidad Catolica de Chile-Centro del Cáncer ( Site 3104)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Bradfordhill-Clinical Area ( Site 3103)
state: Region M. De Santiago
city: Viña del Mar
country: Chile
facility: ONCOCENTRO APYS ( Site 3105)
state: Valparaiso
city: San José
country: Costa Rica
facility: CIMCA ( Site 3300)
state: San Jose
city: San Jose
country: Costa Rica
facility: ICIMED ( Site 3301)
city: Brno
country: Czechia
facility: Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 0700)
state: Brno-mesto
city: Ostrava
country: Czechia
facility: Nemocnice AGEL Ostrava - Vitkovice a.s.-Plicni odd ( Site 0702)
state: Ostrava Mesto
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc-Klinika plicnich nemoci a tuberkulozy ( Site 0701)
city: Praha 2
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze ( Site 0703)
city: Copenhagen
country: Denmark
facility: Rigshospitalet ( Site 0801)
state: Hovedstaden
city: Odense C
country: Denmark
facility: Odense Universitetshospital ( Site 0800)
state: Syddanmark
city: Tallinn
country: Estonia
facility: North Estonia Medical Centre Foundation-Chemotherapy ( Site 0901)
state: Harjumaa
city: Tartu
country: Estonia
facility: Tartu University Hospital-Radiotherapy and oncology ( Site 0900)
state: Tartumaa
city: Tampere
country: Finland
facility: Tampereen yliopistollinen sairaala-Oncology ( Site 1001)
state: Pirkanmaa
city: Vaasa
country: Finland
facility: Vaasan Keskussairaala-Department of Clinical Oncology ( Site 1004)
state: Pohjanmaa
city: Oulu
country: Finland
facility: Oulun yliopistollinen sairaala-Oncology and Hematology ( Site 1003)
state: Pohjois-Pohjanmaa
city: Turku
country: Finland
facility: Turku University Hospital-The Department of Pulmonary Medicine ( Site 1000)
state: Varsinais-Suomi
city: Strasbourg
country: France
facility: Nouvel Hôpital Civil (NHC)-Service de pneumologie ( Site 1100)
state: Alsace
city: Pessac
country: France
facility: CHU Bordeaux Haut-Leveque ( Site 1106)
state: Aquitaine
city: Marseille
country: France
facility: Assistance Publique Hôpitaux de Marseille - Hôpital Nord ( Site 1108)
state: Bouches-du-Rhone
city: Caen
country: France
facility: Centre Hospitalier Universitaire de Caen - Hôpital Côte de Nacre ( Site 1107)
state: Calvados
city: Montpellier
country: France
facility: Hôpital Arnaud de Villeneuve - CHU Montpellier ( Site 1102)
state: Herault
city: ANGERS cedex 02
country: France
facility: Institut de Cancérologie de l'Ouest ( Site 1101)
state: Maine-et-Loire
city: Clermont-Ferrand
country: France
facility: CHU GABRIEL MONTPIED ( Site 1105)
state: Puy-de-Dome
city: Paris
country: France
facility: Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 1104)
city: Esslingen
country: Germany
facility: Klinikum Esslingen-Klinik für Kardiologie und Pneumologie ( Site 1201)
state: Baden-Wurttemberg
city: Gauting
country: Germany
facility: Asklepios Klinik Gauting GmbH-Oncology ( Site 1209)
state: Bayern
city: Kempten
country: Germany
facility: Klinikverbund Allgäu gGmbH ( Site 1205)
state: Bayern
city: Regensburg
country: Germany
facility: Universitaetsklinikum Regensburg ( Site 1204)
state: Bayern
city: Bochum
country: Germany
facility: Augusta-Kranken-Anstalt ( Site 1213)
state: Nordrhein-Westfalen
city: Münster
country: Germany
facility: Gemeinschaftspraxis für Hämatologie und Onkologie Münster ( Site 1202)
state: Nordrhein-Westfalen
city: Paderborn
country: Germany
facility: Brüderkrankenhaus St. Josef Paderborn-Klinik für Hämatologie und Onkologie ( Site 1214)
state: Nordrhein-Westfalen
city: Gera
country: Germany
facility: SRH Wald-Klinikum Gera-Lungenkrebszentrum ( Site 1200)
state: Thuringen
city: Berlin
country: Germany
facility: Helios Klinikum Emil von Behring Berlin-Zehlendorf-Lungenklinik Heckeshorn ( Site 1208)
city: Athens
country: Greece
facility: Errikos Dunant Hospital Center-Fourth Department of Oncology and Clinical Trials Unit ( Site 1301)
state: Attiki
city: Athens
country: Greece
facility: THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA"-3rd Dept of Internal Medicine and Laboratory, Oncol ( Site 1300)
state: Attiki
city: Thessaloniki
country: Greece
facility: European Interbalkan Medical Center-Oncology Department ( Site 1302)
city: Kecskemét
country: Hungary
facility: Bacs-Kiskun Varmegyei Oktatokorhaz-Onkoradiologiai Kozpont ( Site 1401)
state: Bacs-Kiskun
city: Pecs
country: Hungary
facility: Pécsi Tudományegyetem Klinikai Központ-Onkoterápiás Intézet ( Site 1402)
state: Baranya
city: Gyor
country: Hungary
facility: Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz - Pulmonologia Osztaly ( Site 1404)
state: Gyor-Moson-Sopron
city: Törökbálint
country: Hungary
facility: Reformatus Pulmonologiai Centrum ( Site 1405)
state: Pest
city: Kaposvár
country: Hungary
facility: Somogy Varmegyei Kaposi Mor Oktato Korhaz -Onkologiai Kozpont ( Site 1407)
state: Somogy
city: Dublin
country: Ireland
facility: Tallaght University Hospital ( Site 3903)
city: Aviano
country: Italy
facility: CRO-IRCCS-Clinical Oncology ( Site 1510)
state: Friuli-Venezia Giulia
city: Udine
country: Italy
facility: P.O. "S. Maria della Misericordia" Azienda Sanitaria Univers-Oncology Department ( Site 1506)
state: Friuli-Venezia Giulia
city: Milan
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1504)
state: Lombardia
city: Milan
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda-Oncologia Falck ( Site 1511)
state: Milano
city: Naples
country: Italy
facility: A.O.R.N. Ospedale dei Colli - Monaldi V.-U.O.C Pneumologia Oncologica DH PNL ONC ( Site 1508)
state: Napoli
city: Bari
country: Italy
facility: Instituto Tumori Giovanni Paolo II-SSD Oncologia Medica per la Patologia Toracica ( Site 1507)
state: Puglia
city: Catania
country: Italy
facility: POLICLINICO "G. RODOLICO"-UOC Oncologia Medica ( Site 1503)
state: Sicilia
city: Perugia
country: Italy
facility: AO Santa Maria della Misericordia-Oncology Department ( Site 1501)
state: Umbria
city: Cuneo
country: Italy
facility: Azienda Ospedaliera Santa Croce e Carle ( Site 1500)
city: Novara
country: Italy
facility: Azienda Ospedaliero Universitaria Maggiore della Carità ( Site 1502)
city: Kawasaki
country: Japan
facility: St. Marianna University Hospital ( Site 3802)
state: Kanagawa
city: Yokohama
country: Japan
facility: Kanagawa Cancer Center ( Site 3801)
state: Kanagawa
city: Osakasayama
country: Japan
facility: Kindai University Hospital ( Site 3803)
state: Osaka
city: Hiroshima
country: Japan
facility: Hiroshima University Hospital ( Site 3804)
city: Cheongju-si
country: Korea, Republic of
facility: Chungbuk National University Hospital-Internal medicine ( Site 0402)
state: Chungbuk
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center-Lung Cancer Center ( Site 0403)
state: Kyonggi-do
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital-Medical Oncology ( Site 0404)
state: Kyonggi-do
city: Suwon-si
country: Korea, Republic of
facility: The Catholic University Of Korea St. Vincent's Hospital-Medical Oncology ( Site 0406)
state: Kyonggi-do
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital CRC room 1 ( Site 0407)
state: Taegu-Kwangyokshi
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital ( Site 0400)
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center-Department of Oncology ( Site 0405)
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center ( Site 0401)
city: Riga
country: Latvia
facility: RIGA EAST UNIVERSITY HOSPITAL ,Oncology Centre of Latvia ( Site 1600)
city: Kaunas
country: Lithuania
facility: Hospital of Lithuanian University of Health Sciences Kauno klinikos-Pulmonology ( Site 1701)
state: Kauno Apskritis
city: Vilnius
country: Lithuania
facility: National Cancer Institute-Department of Thoracic Surgery and Oncology ( Site 1700)
state: Vilniaus Miestas
city: Lembah Pantai
country: Malaysia
facility: University Malaya Medical Centre ( Site 3502)
state: Kuala Lumpur
city: Putrajaya
country: Malaysia
facility: National Cancer Institute-Radiotherapy and Oncology ( Site 3506)
state: Kuala Lumpur
city: Kuantan
country: Malaysia
facility: Hospital Tengku Ampuan Afzan ( Site 3504)
state: Pahang
city: George Town
country: Malaysia
facility: Hospital Pulau Pinang ( Site 3505)
state: Pulau Pinang
city: Kuching
country: Malaysia
facility: Sarawak General Hospital ( Site 3500)
state: Sarawak
city: Guadalajara
country: Mexico
facility: CIO - Centro de Inmuno-Oncología de Occidente ( Site 3403)
state: Jalisco
city: Monterrey
country: Mexico
facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Hematologia and Oncologia ( Site 3408)
state: Nuevo Leon
city: Chihuahua
country: Mexico
facility: Unidad de Mastologia Avanzada de Chihuahua S.A de C.V ( Site 3402)
city: Chihuahua
country: Mexico
facility: Mediadvance Clinical ( Site 3404)
city: Oaxaca
country: Mexico
facility: Oaxaca Site Management Organization S.C. ( Site 3407)
city: Oaxaca
country: Mexico
facility: Centro de Investigacion Clinica de Oaxaca ( Site 3401)
city: Christchurch
country: New Zealand
facility: New Zealand Clinical Research (Christchurch) ( Site 0300)
state: Canterbury
city: Auckland
country: New Zealand
facility: Harbour Cancer & Wellness ( Site 0301)
city: Lørenskog
country: Norway
facility: Akershus Universitetssykehus-Avdeling for lungesykdommer ( Site 1900)
state: Akershus
city: Drammen
country: Norway
facility: Drammen Sykehus, Vestre Viken HF ( Site 1903)
state: Buskerud
city: Stavanger
country: Norway
facility: Stavanger Universitetssykehus ( Site 1901)
state: Rogaland
city: Davao City
country: Philippines
facility: Metro Davao Medical and Research Center ( Site 3602)
state: Davao Del Sur
city: Quezon City
country: Philippines
facility: ST. LUKE'S MEDICAL CENTER ( Site 3606)
state: National Capital Region
city: San Juan City, Metro Manila
country: Philippines
facility: CARDINAL SANTOS MEDICAL CENTER-Research Room ( Site 3601)
state: National Capital Region
city: Bydgoszcz
country: Poland
facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 2003)
state: Kujawsko-pomorskie
city: Krakow
country: Poland
facility: Krakowski Szpital Specjalistyczny im. Jana Pawła II-Oddział Kliniczny Chirurgii Klatki Piersiowej i ( Site 2011)
state: Malopolskie
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 2000)
state: Mazowieckie
city: Przemysl
country: Poland
facility: Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 2001)
state: Podkarpackie
city: Bialystok
country: Poland
facility: Bialostockie Centrum Onkologii ( Site 2005)
state: Podlaskie
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne ( Site 2013)
state: Pomorskie
city: Olsztyn
country: Poland
facility: Warmińsko - Mazurskie Centrum Chorób Płuc w Olsztynie-Oddzial Onkologii z Pododdzialem Chemioterapii ( Site 2008)
state: Warminsko-mazurskie
city: Poznan
country: Poland
facility: Wielkopolskie Centrum Pulmonologii i Torakochirurgii-Oddzial Onkologii Klinicznej z Pododdzialem Dz ( Site 2002)
state: Wielkopolskie
city: Lisbon
country: Portugal
facility: Unidade Local de Saude de Santa Maria - Hospital Pulido Valente ( Site 2703)
state: Lisboa
city: Porto
country: Portugal
facility: Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 2702)
city: Banska Bystrica
country: Slovakia
facility: Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica ( Site 2202)
state: Banskobystricky Kraj
city: Bratislava
country: Slovakia
facility: Univerzitná nemocnica Bratislava - Nemocnica Ružinov ( Site 2201)
state: Bratislavsky Kraj
city: L'Hospitalet de Llobregat
country: Spain
facility: Institut Català d'Oncologia - L'Hospitalet-Medical Oncology ( Site 2401)
state: Barcelona
city: Majadahonda
country: Spain
facility: HOSPITAL UNIVERSITARIO PUERTA DE HIERRO MAJADAHONDA-Medical Oncology ( Site 2403)
state: Madrid, Comunidad De
city: Pozuelo de Alarcon
country: Spain
facility: HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 2402)
state: Madrid
city: Málaga
country: Spain
facility: Hospital Quirón Málaga ( Site 2405)
state: Malaga
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 2400)
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 2404)
city: Taipei City
country: Taiwan
facility: National Taiwan University Cancer Center (NTUCC) ( Site 0500)
state: Taipei
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital ( Site 0504)
city: Hsinchu
country: Taiwan
facility: National Taiwan University Hospital - Hsinchu branch ( Site 0501)
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital-Chest ( Site 0503)
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital-Clinical Trial Center ( Site 0505)
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital-Oncology ( Site 0506)
city: Taipei
country: Taiwan
facility: Taipei Medical University Hospital ( Site 0502)
city: Stanbul
country: Turkey
facility: Medipol Mega Universite Hastanesi-oncology ( Site 2105)
state: Istanbul
city: Bornova
country: Turkey
facility: Ege Universitesi Hastanesi-Chest Diseases Department ( Site 2107)
state: Izmir
city: Ankara
country: Turkey
facility: Hacettepe Universite Hastaneleri-oncology hospital ( Site 2100)
city: Ankara
country: Turkey
facility: Memorial Ankara Hastanesi-Medical Oncology ( Site 2103)
city: Ankara
country: Turkey
facility: Liv Hospital Ankara-Oncology ( Site 2104)
city: Ankara
country: Turkey
facility: Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 2101)
city: Istanbul
country: Turkey
facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2102)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: