Clinical trial NCT06211036: Study Comparing Tarlatamab and Durvalumab Versus Durvalumab Alone in First-Line Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following Platinum, Etoposide and Durvalumab
Official title: A Phase 3, Open-label, Multicenter, Randomized Study of Tarlatamab in Combination With Durvalumab vs Durvalumab Alone in Subjects With Extensive-Stage Small-Cell Lung Cancer Following Platinum, Etoposide and Durvalumab (DeLLphi-305)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Extensive-Stage Small-Cell Lung Cancer
Small-Cell Lung Cancer
Keywords: Extensive-Stage Small-Cell Lung Cancer
ES-SCLC
Platinum
Etoposide
Durvalumab
Tarlatamab
AMG 757
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2024-01-18
Enrollment: 550
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to compare the efficacy of tarlatamab plus durvalumab with durvalumab alone on prolonging overall survival (OS).


Eligibility criteria: Inclusion:

* Participant has provided informed consent prior to initiation of any study specific activities/procedures.
* Age \>= 18 years (or \>= legal adult age within the country if it is older than 18 years).
* Completed 3-4 cycles of platinum-etoposide chemotherapy with concurrent durvalumab as first-line treatment of extensive-stage (ES)-SCLC prior to enrollment, without disease progression (ongoing response or stable disease) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1.
* Minimum life expectancy \> 12 weeks.
* Toxicities attributed to prior anti-cancer therapy resolved to grade ≤ 1, unless otherwise specified, excluding alopecia or fatigue.
* Adequate organ function.
* Histologically or cytologically documented extensive-stage disease (American Joint Committee on Cancer, 2017, IV small-cell lung cancer (SCLC) \[T any, N any, M1 a/b/c\]), or T3 to T4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan. Participants with prior limited-stage (LS)-SCLC are allowed if the interval is \> 6 months since the end of previous therapy and progression, in discussion with the medical monitor.

Exclusion

* Symptomatic central nervous system (CNS) metastases, or leptomeningeal disease. Participants with treated brain metastases are eligible as per protocol.
* Prior history of severe or life-threatening events from any immune-mediated therapy.
* History of other malignancy within the past 2 years, with some exceptions as per protocol.
* Active or prior documented autoimmune or inflammatory disorders as per protocol.
* Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association \> class II) within 6 months of first dose of study treatment.
* History of arterial thrombosis (e.g., stroke or transient ischemic attack) within 6 months of first dose of study treatment.
* Evidence of interstitial lung disease (ILD) or active, non-infectious pneumonitis.
* History of solid organ transplant.
* Major surgical procedures within 28 days of first dose of study treatment.
* Known human immunodeficiency virus (HIV) infection (participants with HIV infection on antiviral therapy and undetectable viral load are permitted with a requirement for regular monitoring for reactivation for the duration of treatment on study), hepatitis C infection (participants with hepatitis C that achieve a sustained virologic response after antiviral therapy are allowed), or hepatitis B infection (participants with hepatitis B surface antigen \[HBsAg\] or core antibody that achieve sustained virologic response with antiviral therapy are permitted with a requirement for regular monitoring for reactivation for the duration of treatment on the study).
* Receiving systemic corticosteroid therapy or any other form of immunosuppressive therapy within 14 days prior to first dose of study treatment.
* History of allergic reactions or acute hypersensitivity reaction to antibody therapies, platinum chemotherapy, or etoposide.
* Participant with symptoms and/or clinical signs and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection within 7 days prior to the first dose of study treatment.
* Participant has known active infection requiring parenteral antibiotic treatment. Upon completion of parenteral antibiotics and resolution of symptoms, the participant may be considered eligible for the study from an infection standpoint.
* Treatment with live virus, including live-attenuated vaccination, within 4 weeks prior to the first dose of study treatment. Inactive vaccines (e.g., non-live or non-replicating agent) and live viral non-replicating vaccines (e.g., Jynneos for Monkeypox infection) within 30 days prior to first dose of study treatment.
* Prior therapy with any selective inhibitor of the delta-like ligand 3 (DLL3) pathway.
* Receiving another anti-cancer therapy. Adjuvant hormonal therapy for resected breast cancer is permitted.
* Treatment in an alternative investigational trial within 28 days prior to enrollment.
* Has received or is planning to receive consolidative chest radiation for extensive stage disease.
* Female participants of childbearing potential unwilling to use protocol specified method of contraception during treatment as per protocol.
* Female participants who are breastfeeding or who plan to breastfeed while on study as per protocol.
* Female participants planning to become pregnant or donate eggs while on study as per protocol.
* Female participants of childbearing potential with a positive pregnancy test assessed at screening by a highly sensitive serum pregnancy test.
* Male participants with a female partner of childbearing potential who are unwilling to practice sexual abstinence (refrain from heterosexual intercourse) or use contraception during treatment as per protocol.
* Male participants with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment as per protocol.
* Male participants unwilling to abstain from donating sperm during treatment as per protocol.
* Participant has known sensitivity to any of the products or components to be administered during dosing.
* Participant has known sensitivity to any of the products or components to be administered during dosing.
* History or evidence of any other clinically significant disorder, condition or disease that, in the opinion of the investigator or physician if consulted, would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion.
* Participant likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (eg, Clinical Outcome Assessments) to the best of the participant and investigator's knowledge. Participants who are unable to complete clinical outcome assessments are eligible.

Primary outcomes:
measure: OS
timeFrame: Up to approximately 3 years
Secondary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: Up to approximately 3 years
measure: Overall Response (OR)
timeFrame: Up to approximately 3 years
measure: Disease Control (DC) Rate
timeFrame: Up to approximately 3 years
measure: Duration of Response (DoR)
timeFrame: Up to approximately 3 years
measure: PFS at 6 Months
timeFrame: 6 months
measure: PFS at 1 Year
timeFrame: 1 year
measure: PFS at 2 Years
timeFrame: 2 years
measure: OS at 6 Months
timeFrame: 6 months
measure: OS at 1 Year
timeFrame: 1 year
measure: OS at 2 Years
timeFrame: 2 years
measure: OS at 3 Years
timeFrame: 3 years
measure: Time to Progression (TTP)
timeFrame: Up to approximately 3 years
measure: Number of Participants with Treatment-emergent Adverse Events (TEAEs)
timeFrame: Up to approximately 9 months
measure: Number of Participants with TEAEs Grade 3 or Above per Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
timeFrame: Up to approximately 3 years
measure: Number of Participants with Serious TEAEs
timeFrame: Up to approximately 3 years
measure: Number of Participants with TEAEs Leading to Discontinuation of Treatment
timeFrame: Up to approximately 3 years
measure: Number of Participants with Fatal TEAEs
timeFrame: Up to approximately 3 years
measure: Number of Participants with Treatment-related Adverse Events (AEs)
timeFrame: Up to approximately 9 months
measure: Number of Participants with Adverse Events of Interest (EOI)
timeFrame: Up to approximately 9 months
measure: Serum Concentrations of Tarlatamab
timeFrame: Day 1 up to approximately 6 months
measure: Number of Participants with Antitarlatamab Antibody Formation
timeFrame: Up to approximately 9 months
measure: Time to First Deterioration (TTD) for Physical Function as Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30 (EORTC-QLQ-C30)
timeFrame: Up to approximately 9 months
measure: Change in Disease Symptoms of Cough as Measured Using EORTC-QLQ LC13
timeFrame: Up to 12 months
measure: Change in Disease Symptoms of Chest Pain as Measured Using EORTC-QLQ LC13
timeFrame: Up to 12 months
measure: Change in Disease Symptoms of Dyspnea as Measured Using EORTC-QLQ LC13
timeFrame: Up to 12 months
measure: TTD for Global Health Status as Measured by EORTC-QLQ-C30
timeFrame: Up to approximately 9 months
measure: TTD for Quality of Life as Measured by EORTC-QLQ-C30
timeFrame: Up to approximately 9 months
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Infirmary Cancer Center
state: Alabama
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Athens
country: United States
facility: University Cancer and Blood Center LLC
state: Georgia
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Gainesville
country: United States
facility: Northeast Georgia Medical Center
state: Georgia
city: Chicago
country: United States
facility: University of Illinois Chicago
state: Illinois
city: Indianapolis
country: United States
facility: Franciscan Health Indianapolis
state: Indiana
city: Baton Rouge
country: United States
facility: Our Lady of the Lake Cancer Institute
state: Louisiana
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Grand Rapids
country: United States
facility: Cancer and Hematology Centers of Western Michigan
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Paul
country: United States
facility: Allina Health System dba Allina Health Cancer Institute
state: Minnesota
city: Springfield
country: United States
facility: Oncology Hematology Associates
state: Missouri
city: Omaha
country: United States
facility: Nebraska Cancer Specialists
state: Nebraska
city: East Brunswick
country: United States
facility: Astera Cancer Care
state: New Jersey
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of NJ
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center - Bronx
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Cincinnati
country: United States
facility: Oncology Hematology Care Incorporated
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Eugene
country: United States
facility: Oncology Associates of Oregon, PC
state: Oregon
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Pittsburgh
country: United States
facility: Allegheny Health Network
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Memphis
country: United States
facility: Baptist Cancer Center Memphis Thoracic
state: Tennessee
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: Dallas
country: United States
facility: Texas Oncology - Dallas Fort Worth
state: Texas
city: Dallas
country: United States
facility: US Oncology Research Investigational Products Center
state: Texas
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
city: Newport News
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University Massey Cancer Center
state: Virginia
city: Seattle
country: United States
facility: Swedish Cancer Institute
state: Washington
city: Milwaukee
country: United States
facility: The Medical College of Wisconsin
state: Wisconsin
city: Caba
country: Argentina
facility: Hospital Britanico de Buenos Aires
state: Buenos Aires
city: Capital Federal
country: Argentina
facility: Instituto Alexander Fleming
state: Buenos Aires
city: Cipolletti
country: Argentina
facility: Fundacion Medica de Rio Negro y Neuquen
state: Río Negro
city: San miguel de tucuman
country: Argentina
facility: Exelsus Oncologia Clinica
state: Tucuman
city: La Rioja
country: Argentina
facility: Fundacion Centro Oncológico Riojano Integral para la Investigación y Prevención del Cáncer
city: Camperdown
country: Australia
facility: Chris OBrien Lifehouse
state: New South Wales
city: Wollongong
country: Australia
facility: Wollongong Hospital
state: New South Wales
city: Greenslopes
country: Australia
facility: Greenslopes Private Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Cancer Research South Australia
state: South Australia
city: Clayton
country: Australia
facility: Monash Medical Centre
state: Victoria
city: Nedlands
country: Australia
facility: Sir Charles Gairdner Hospital
state: Western Australia
city: Graz
country: Austria
facility: Medizinische Universitaet Graz
city: Krems
country: Austria
facility: Universitaetsklinikum Krems
city: Rankweil
country: Austria
facility: Landeskrankenhaus Feldkirch
city: Aalst
country: Belgium
facility: Azorg Campus Aalst - Moorselbaan
city: Brussels
country: Belgium
facility: Institut Jules Bordet
city: Brussel
country: Belgium
facility: Universitair Ziekenhuis Brussel
city: Bruxelles
country: Belgium
facility: Universite Catholique de Louvain Cliniques Universitaires Saint Luc
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
city: Gent
country: Belgium
facility: Algemeen Ziekenhuis Maria Middelares
city: Mons
country: Belgium
facility: Centres Hospitaliers Universitaires - Helora - Hopital de Mons - Site Kennedy
city: Yvoir
country: Belgium
facility: Centre Hospitalier Universitaire-Universite Catholique de Louvain Namur-Site Godinne
city: Salvador
country: Brazil
facility: Hospital Sao Rafael-Idor
state: Bahia
city: Belo Horizonte
country: Brazil
facility: Cenantron Centro Avançado de Tratamento Oncologico Ltda
state: Minas Gerais
city: Passos
country: Brazil
facility: Santa Casa de Misericordia de Passos
state: Minas Gerais
city: Cascavel
country: Brazil
facility: Hospital Uopeccan
state: Paraná
city: Ijui
country: Brazil
facility: Hospital de Clinicas de Ijui
state: Rio Grande Do Sul
city: Passo Fundo
country: Brazil
facility: Hospital de Clinicas de Passo Fundo
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Irmandade da Santa Casa de Misericordia de Porto Alegre
state: Rio Grande Do Sul
city: Sao Paulo
country: Brazil
facility: Fundacao Antonio Prudente AC Camargo Cancer Center
state: São Paulo
city: Sao Paulo
country: Brazil
facility: Hospital Israelita Albert Einstein
state: São Paulo
city: Rio de Janeiro
country: Brazil
facility: Oncoclinicas Rio de Janeiro S A
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Quebec
country: Canada
facility: CHU de Quebec Hopital de l Enfant Jesus
city: Beijing
country: China
facility: Beijing Chaoyang Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Chongqing
country: China
facility: Xinqiao Hospital
state: Chongqing
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
state: Fujian
city: Quanzhou
country: China
facility: The Second Attached Hospital Of Fujian Medical University
state: Fujian
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Guilin
country: China
facility: Affiliated Hospital of Guilin Medical University
state: Guangxi
city: Nanning
country: China
facility: Guangxi Medical University Affiliated Tumor Hospital
state: Guangxi
city: Cangzhou
country: China
facility: Cangzhou Peoples Hospital
state: Hebei
city: Jiamusi
country: China
facility: Jiamusi Cancer Hospital
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: Hubei Cancer Hospital
state: Hubei
city: Hohhot
country: China
facility: The Affiliated Hospital of Inner Mongolia Medical University
state: Inner Mongolia
city: Nanjing
country: China
facility: Nanjing Chest Hospital
state: Jiangsu
city: Xuzhou
country: China
facility: Xuzhou Central Hospital
state: Jiangsu
city: Nanchang
country: China
facility: Jiangxi Cancer hospital
state: Jiangxi
city: Changchun
country: China
facility: Jilin Cancer Hospital
state: Jilin
city: Jinan
country: China
facility: The Affiliated Cancer Hospital of Shandong First Medical University
state: Shandong
city: Linyi
country: China
facility: Linyi Cancer Hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
state: Shanghai
city: Taiyuan
country: China
facility: Shanxi Provincial Cancer Hospital
state: Shanxi
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xian Jiaotong University
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Peoples Hospital
state: Tianjin
city: Urumqi
country: China
facility: Affiliated Cancer Hospital of Xinjiang Medical University
state: Xinjiang
city: Hangzhou
country: China
facility: the First Affiliated Hospital Zhejiang University School of Medicine
state: Zhejiang
city: Ningbo
country: China
facility: The First Affiliated Hospital Of Ningbo University
state: Zhejiang
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Brno
country: Czechia
facility: Fakultni nemocnice Brno
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc
city: Ostrava-Vitkovice
country: Czechia
facility: Nemocnice Agel Ostrava-Vitkovice as
city: Praha 2
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze
city: Praha 5
country: Czechia
facility: Fakultni nemocnice v Motole
city: Herning
country: Denmark
facility: Regionshospitalet Godstrup
city: Kobenhavn
country: Denmark
facility: Rigshospitalet
city: Odense C
country: Denmark
facility: Odense Universitetshospital
city: Bordeaux
country: France
facility: Institut Bergonie
city: Brest
country: France
facility: Centre Hospitalier Regional Universitaire de Brest - Hopital Morvan
city: Creteil
country: France
facility: Centre Hospitalier Intercommunal de Creteil
city: Le Mans
country: France
facility: Centre Hospitalier - Le Mans
city: Lyon
country: France
facility: Centre Leon Berard
city: Marseille Cedex 20
country: France
facility: Centre Hospitalier Universitaire Nord
city: Montpellier Cedex 5
country: France
facility: Institut regional du Cancer Montpellier
city: Paris
country: France
facility: Hopital Cochin
city: Saint Herblain
country: France
facility: Centre Hospitalier Universitaire de Nantes - Hopital Nord Laennec
city: Strasbourg Cedex
country: France
facility: Centre Hospitalier Universitaire de Strasbourg - Nouvel Hopital Civil
city: Toulouse Cedex 9
country: France
facility: Centre Hospitalier Universitaire de Toulouse - Hopital Larrey
city: Valenciennes
country: France
facility: Clinique Teissier
city: Dresden
country: Germany
facility: Universitaetsklinikum Dresden
city: Essen
country: Germany
facility: Universitaetsklinikum Essen
city: Gauting
country: Germany
facility: Asklepios Fachkliniken Muenchen Gauting
city: Grosshansdorf
country: Germany
facility: LungenClinic Grosshansdorf GmbH
city: Heidelberg
country: Germany
facility: Universitaetsklinikum Heidelberg
city: Koeln
country: Germany
facility: Kliniken der Stadt Koeln gGmbH
city: Muenster
country: Germany
facility: University Hospital Muenster
city: Wuerzburg
country: Germany
facility: Universitaetsklinikum Wuerzburg
city: Athens
country: Greece
facility: Henry Dunant Hospital Center
city: Athens
country: Greece
facility: Sotiria General Hospital
city: Athens
country: Greece
facility: Attikon University Hospital
city: Athens
country: Greece
facility: Metropolitan General
city: Athens
country: Greece
facility: Metropolitan Hospital
city: Thessaloniki
country: Greece
facility: Saint Lukes Hospital SA
city: Thessaloniki
country: Greece
facility: European Interbalkan Medical Center
city: Kowloon
country: Hong Kong
facility: Princess Margaret Hospital
city: Shatin, New Territories
country: Hong Kong
facility: Prince of Wales Hospital, Chinese University of Hong Kong
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Budapest
country: Hungary
facility: Orszagos Koranyi Pulmonologiai Intezet
city: Gyongyos
country: Hungary
facility: Matrai Gyogyintezet
city: Gyor
country: Hungary
facility: Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktatokorhaz
city: Szekesfehervar
country: Hungary
facility: Fejer Varmegyei Szent Gyorgy Egyetemi Oktato Korhaz
city: Torokbalint
country: Hungary
facility: Reformatus Pulmonologiai Centrum
city: Dublin
country: Ireland
facility: Beaumont Hospital
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
city: Bari
country: Italy
facility: IRCCS Istituto Tumori Giovanni Paolo II
city: Milano
country: Italy
facility: IRCCS Istituto Oncologico Europeo
city: Milano
country: Italy
facility: Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
city: Verona
country: Italy
facility: Centro Ricerche Cliniche Di Verona Societa responsabilita limitata
city: Nagoya-shi
country: Japan
facility: Aichi Cancer Center
state: Aichi
city: Kashiwa-shi
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Matsuyama-shi
country: Japan
facility: National Hospital Organization Shikoku Cancer Center
state: Ehime
city: Fukuoka-shi
country: Japan
facility: Kyushu University Hospital
state: Fukuoka
city: Kurume-shi
country: Japan
facility: Kurume University Hospital
state: Fukuoka
city: Sapporo-shi
country: Japan
facility: National Hospital Organization Hokkaido Cancer Center
state: Hokkaido
city: Akashi-shi
country: Japan
facility: Hyogo Cancer Center
state: Hyogo
city: Yokohama-shi
country: Japan
facility: Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center
state: Kanagawa
city: Niigata-shi
country: Japan
facility: Niigata Cancer Center Hospital
state: Niigata
city: Okayama-shi
country: Japan
facility: Okayama University Hospital
state: Okayama
city: Hirakata-shi
country: Japan
facility: Kansai Medical University Hospital
state: Osaka
city: Osaka-shi
country: Japan
facility: Osaka International Cancer Institute
state: Osaka
city: Osakasayama-shi
country: Japan
facility: Kindai University Hospital
state: Osaka
city: Hidaka-shi
country: Japan
facility: Saitama Medical University International Medical Center
state: Saitama
city: Sunto-gun
country: Japan
facility: Shizuoka Cancer Center
state: Shizuoka
city: Bunkyo-ku
country: Japan
facility: Juntendo University Hospital
state: Tokyo
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Koto-ku
country: Japan
facility: The Cancer Institute Hospital of Japanese Foundation for Cancer Research
state: Tokyo
city: Wakayama-shi
country: Japan
facility: Wakayama Medical University Hospital
state: Wakayama
city: Cheongju Chungbuk
country: Korea, Republic of
facility: Chungbuk National University Hospital
city: Goyang-si Gyeonggi-do
country: Korea, Republic of
facility: National Cancer Center
city: Seongnam-si, Gyeonggi-do
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Ciudad de México
country: Mexico
facility: Oncare
state: Distrito Federal
city: Mexico City
country: Mexico
facility: Health Pharma Professional Research SA de CV
state: Distrito Federal
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen
city: Maastricht
country: Netherlands
facility: Maastricht Universitair Medisch Centrum
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
city: Poznan
country: Poland
facility: Wielkopolskie Centrum Pulmonologii i Torakochirurgii imienia Eugenii i Janusza Zeylandow
city: Warszawa
country: Poland
facility: Instytut Gruzlicy i Chorob Pluc
city: Wroclaw
country: Poland
facility: Dolnoslaskie Centrum Onkologii, Pulmonologii i Hematologii
city: Lisboa
country: Portugal
facility: Hospital da Luz, SA
city: Lisboa
country: Portugal
facility: Hospital Cuf Descobertas
city: Matosinhos
country: Portugal
facility: Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano
city: Porto
country: Portugal
facility: Hospital Cuf porto
city: Cluj Napoca
country: Romania
facility: Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca
city: Ploiesti
country: Romania
facility: Spitalul Municipal Ploiesti
city: Malaga
country: Spain
facility: Hospital Regional Universitario de Malaga
state: Andalucía
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
state: Andalucía
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d Hebron
state: Cataluña
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial de Barcelona
state: Cataluña
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
state: Cataluña
city: Hospitalet de Llobregat
country: Spain
facility: Institut Catala d Oncologia Hospitalet Hospital Duran i Reynals
state: Cataluña
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe
state: Comunidad Valenciana
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra
state: Navarra
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Basel
country: Switzerland
facility: Universitaetsspital Basel
city: Bern
country: Switzerland
facility: Inselspital Bern
city: Mendrisio
country: Switzerland
facility: Ospedale Regionale di Bellinzona e Vali
city: Sankt Gallen
country: Switzerland
facility: Kantonsspital Sankt Gallen
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Ankara
country: Turkey
facility: Ankara Bilkent Sehir Hastanesi
city: Istanbul
country: Turkey
facility: Bagcilar Medipol Mega Universite Hastanesi
city: Izmir
country: Turkey
facility: Izmir Katip Celebi Universitesi Ataturk Egitim ve Arastirma Hastanesi
city: Mersin
country: Turkey
facility: Medical Park Seyhan Hastanesi
city: Mersin
country: Turkey
facility: VM Medical Park Mersin Hastanesi
city: Sakarya
country: Turkey
facility: Sakarya Egitim ve Arastirma Hastanesi
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: