Study Comparing Tarlatamab and Durvalumab Versus Durvalumab Alone in First-Line Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following Platinum, Etoposide and Durvalumab
- Conditions
- Extensive-Stage Small-Cell Lung CancerSmall-Cell Lung Cancer
- Interventions
- Registration Number
- NCT06211036
- Lead Sponsor
- Amgen
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 550
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tarlatamab in Combination With Durvalumab Tarlatamab Participants will receive tarlatamab once every 2 weeks (Q2W) and durvalumab once every 4 weeks (Q4W). Tarlatamab in Combination With Durvalumab Durvalumab Participants will receive tarlatamab once every 2 weeks (Q2W) and durvalumab once every 4 weeks (Q4W). Durvalumab Alone Durvalumab Participants will receive durvalumab Q4W alone.
- Primary Outcome Measures
Name Time Method OS Up to approximately 3 years
- Secondary Outcome Measures
Name Time Method Progression Free Survival (PFS) Up to approximately 3 years Overall Response (OR) Up to approximately 3 years Disease Control (DC) Rate Up to approximately 3 years Duration of Response (DoR) Up to approximately 3 years PFS at 6 Months 6 months PFS at 1 Year 1 year PFS at 2 Years 2 years OS at 6 Months 6 months OS at 1 Year 1 year OS at 2 Years 2 years OS at 3 Years 3 years Time to Progression (TTP) Up to approximately 3 years Number of Participants with Treatment-emergent Adverse Events (TEAEs) Up to approximately 9 months TTD for Global Health Status as Measured by EORTC-QLQ-C30 Up to approximately 9 months TTD for Quality of Life as Measured by EORTC-QLQ-C30 Up to approximately 9 months Number of Participants with TEAEs Grade 3 or Above per Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Up to approximately 3 years Number of Participants with Serious TEAEs Up to approximately 3 years Number of Participants with TEAEs Leading to Discontinuation of Treatment Up to approximately 3 years Number of Participants with Fatal TEAEs Up to approximately 3 years Number of Participants with Treatment-related Adverse Events (AEs) Up to approximately 9 months Number of Participants with Adverse Events of Interest (EOI) Up to approximately 9 months Serum Concentrations of Tarlatamab Day 1 up to approximately 6 months Number of Participants with Antitarlatamab Antibody Formation Up to approximately 9 months 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) Up to approximately 9 months Change in Disease Symptoms of Cough as Measured Using EORTC-QLQ LC13 Up to 12 months Change in Disease Symptoms of Chest Pain as Measured Using EORTC-QLQ LC13 Up to 12 months Change in Disease Symptoms of Dyspnea as Measured Using EORTC-QLQ LC13 Up to 12 months
Trial Locations
- Locations (218)
Odense Universitetshospital
🇩🇰Odense C, Denmark
Severance Hospital Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Jiamusi Cancer Hospital
🇨🇳Jiamusi, Heilongjiang, China
Juntendo University Hospital
🇯🇵Bunkyo-ku, Tokyo, Japan
National Cancer Center Hospital
🇯🇵Chuo-ku, Tokyo, Japan
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
🇯🇵Koto-ku, Tokyo, Japan
Wakayama Medical University Hospital
🇯🇵Wakayama-shi, Wakayama, Japan
Chungbuk National University Hospital
🇰🇷Cheongju Chungbuk, Korea, Republic of
National Cancer Center
🇰🇷Goyang-si Gyeonggi-do, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Henan Cancer Hospital
🇨🇳Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
Hubei Cancer Hospital
🇨🇳Wuhan, Hubei, China
The Affiliated Hospital of Inner Mongolia Medical University
🇨🇳Hohhot, Inner Mongolia, China
Nanjing Chest Hospital
🇨🇳Nanjing, Jiangsu, China
Xuzhou Central Hospital
🇨🇳Xuzhou, Jiangsu, China
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Oncare
🇲🇽Ciudad de México, Distrito Federal, Mexico
Health Pharma Professional Research SA de CV
🇲🇽Mexico City, Distrito Federal, Mexico
Jiangxi Cancer hospital
🇨🇳Nanchang, Jiangxi, China
Universitair Medisch Centrum Groningen
🇳🇱Groningen, Netherlands
Maastricht Universitair Medisch Centrum
🇳🇱Maastricht, Netherlands
Erasmus Medisch Centrum
🇳🇱Rotterdam, Netherlands
Uniwersyteckie Centrum Kliniczne
🇵🇱Gdansk, Poland
Jilin Cancer Hospital
🇨🇳Changchun, Jilin, China
The Affiliated Cancer Hospital of Shandong First Medical University
🇨🇳Jinan, Shandong, China
Linyi Cancer Hospital
🇨🇳Linyi, Shandong, China
Wielkopolskie Centrum Pulmonologii i Torakochirurgii imienia Eugenii i Janusza Zeylandow
🇵🇱Poznan, Poland
Instytut Gruzlicy i Chorob Pluc
🇵🇱Warszawa, Poland
Dolnoslaskie Centrum Onkologii, Pulmonologii i Hematologii
🇵🇱Wroclaw, Poland
Hospital da Luz, SA
🇵🇹Lisboa, Portugal
Hospital Cuf Descobertas
🇵🇹Lisboa, Portugal
Shanghai Chest Hospital
🇨🇳Shanghai, Shanghai, China
Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano
🇵🇹Matosinhos, Portugal
Hospital Cuf porto
🇵🇹Porto, Portugal
Shanghai Pulmonary Hospital
🇨🇳Shanghai, Shanghai, China
Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca
🇷🇴Cluj Napoca, Romania
Shanxi Provincial Cancer Hospital
🇨🇳Taiyuan, Shanxi, China
The First Affiliated Hospital of Xian Jiaotong University
🇨🇳Xi'an, Shanxi, China
West China Hospital of Sichuan University
🇨🇳Chengdu, Sichuan, China
Tianjin Peoples Hospital
🇨🇳Tianjin, Tianjin, China
Affiliated Cancer Hospital of Xinjiang Medical University
🇨🇳Urumqi, Xinjiang, China
the First Affiliated Hospital Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
The First Affiliated Hospital Of Ningbo University
🇨🇳Ningbo, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
🇨🇳Wenzhou, Zhejiang, China
Fakultni nemocnice Brno
🇨🇿Brno, Czechia
Fakultni nemocnice Olomouc
🇨🇿Olomouc, Czechia
Nemocnice Agel Ostrava-Vitkovice as
🇨🇿Ostrava-Vitkovice, Czechia
Spitalul Municipal Ploiesti
🇷🇴Ploiesti, Romania
Vseobecna fakultni nemocnice v Praze
🇨🇿Praha 2, Czechia
Fakultni nemocnice v Motole
🇨🇿Praha 5, Czechia
Regionshospitalet Godstrup
🇩🇰Herning, Denmark
Rigshospitalet
🇩🇰Kobenhavn, Denmark
Institut Bergonie
🇫🇷Bordeaux, France
Centre Hospitalier Regional Universitaire de Brest - Hopital Morvan
🇫🇷Brest, France
Centre Hospitalier Intercommunal de Creteil
🇫🇷Creteil, France
Centre Hospitalier - Le Mans
🇫🇷Le Mans, France
Centre Leon Berard
🇫🇷Lyon, France
Centre Hospitalier Universitaire Nord
🇫🇷Marseille Cedex 20, France
Institut regional du Cancer Montpellier
🇫🇷Montpellier Cedex 5, France
Hopital Cochin
🇫🇷Paris, France
Centre Hospitalier Universitaire de Nantes - Hopital Nord Laennec
🇫🇷Saint Herblain, France
Centre Hospitalier Universitaire de Strasbourg - Nouvel Hopital Civil
🇫🇷Strasbourg Cedex, France
Centre Hospitalier Universitaire de Toulouse - Hopital Larrey
🇫🇷Toulouse Cedex 9, France
Clinique Teissier
🇫🇷Valenciennes, France
Universitaetsklinikum Dresden
🇩🇪Dresden, Germany
Universitaetsklinikum Essen
🇩🇪Essen, Germany
Asklepios Fachkliniken Muenchen Gauting
🇩🇪Gauting, Germany
LungenClinic Grosshansdorf GmbH
🇩🇪Grosshansdorf, Germany
Universitaetsklinikum Heidelberg
🇩🇪Heidelberg, Germany
Kliniken der Stadt Koeln gGmbH
🇩🇪Koeln, Germany
University Hospital Muenster
🇩🇪Muenster, Germany
Universitaetsklinikum Wuerzburg
🇩🇪Wuerzburg, Germany
Henry Dunant Hospital Center
🇬🇷Athens, Greece
Sotiria General Hospital
🇬🇷Athens, Greece
Attikon University Hospital
🇬🇷Athens, Greece
Metropolitan General
🇬🇷Athens, Greece
Metropolitan Hospital
🇬🇷Athens, Greece
Saint Lukes Hospital SA
🇬🇷Thessaloniki, Greece
European Interbalkan Medical Center
🇬🇷Thessaloniki, Greece
Hospital Regional Universitario de Malaga
🇪🇸Malaga, Andalucía, Spain
Princess Margaret Hospital
🇭🇰Kowloon, Hong Kong
Prince of Wales Hospital, Chinese University of Hong Kong
🇭🇰Shatin, New Territories, Hong Kong
Semmelweis Egyetem
🇭🇺Budapest, Hungary
Orszagos Koranyi Pulmonologiai Intezet
🇭🇺Budapest, Hungary
Matrai Gyogyintezet
🇭🇺Gyongyos, Hungary
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktatokorhaz
🇭🇺Gyor, Hungary
Fejer Varmegyei Szent Gyorgy Egyetemi Oktato Korhaz
🇭🇺Szekesfehervar, Hungary
Reformatus Pulmonologiai Centrum
🇭🇺Torokbalint, Hungary
Beaumont Hospital
🇮🇪Dublin, Ireland
Rambam Medical Center
🇮🇱Haifa, Israel
Shaare Zedek Medical Center
🇮🇱Jerusalem, Israel
Meir Medical Center
🇮🇱Kfar Saba, Israel
Rabin Medical Center
🇮🇱Petah Tikva, Israel
IRCCS Istituto Tumori Giovanni Paolo II
🇮🇹Bari, Italy
IRCCS Istituto Oncologico Europeo
🇮🇹Milano, Italy
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
🇮🇹Milano, Italy
Centro Ricerche Cliniche Di Verona Societa responsabilita limitata
🇮🇹Verona, Italy
Hospital Universitario Virgen Macarena
🇪🇸Sevilla, Andalucía, Spain
Aichi Cancer Center
🇯🇵Nagoya-shi, Aichi, Japan
National Cancer Center Hospital East
🇯🇵Kashiwa-shi, Chiba, Japan
National Hospital Organization Shikoku Cancer Center
🇯🇵Matsuyama-shi, Ehime, Japan
Kyushu University Hospital
🇯🇵Fukuoka-shi, Fukuoka, Japan
Kurume University Hospital
🇯🇵Kurume-shi, Fukuoka, Japan
National Hospital Organization Hokkaido Cancer Center
🇯🇵Sapporo-shi, Hokkaido, Japan
Hyogo Cancer Center
🇯🇵Akashi-shi, Hyogo, Japan
Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center
🇯🇵Yokohama-shi, Kanagawa, Japan
Niigata Cancer Center Hospital
🇯🇵Niigata-shi, Niigata, Japan
Okayama University Hospital
🇯🇵Okayama-shi, Okayama, Japan
Kansai Medical University Hospital
🇯🇵Hirakata-shi, Osaka, Japan
Infirmary Cancer Center
🇺🇸Mobile, Alabama, United States
University of Southern California
🇺🇸Los Angeles, California, United States
Yale New Haven Hospital
🇺🇸New Haven, Connecticut, United States
University Cancer and Blood Center LLC
🇺🇸Athens, Georgia, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Northeast Georgia Medical Center
🇺🇸Gainesville, Georgia, United States
University of Illinois Chicago
🇺🇸Chicago, Illinois, United States
Franciscan Health Indianapolis
🇺🇸Indianapolis, Indiana, United States
Our Lady of the Lake Cancer Institute
🇺🇸Baton Rouge, Louisiana, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Cancer and Hematology Centers of Western Michigan
🇺🇸Grand Rapids, Michigan, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Allina Health System dba Allina Health Cancer Institute
🇺🇸Saint Paul, Minnesota, United States
Swedish Cancer Institute
🇺🇸Seattle, Washington, United States
Oncology Hematology Associates
🇺🇸Springfield, Missouri, United States
Nebraska Cancer Specialists
🇺🇸Omaha, Nebraska, United States
Astera Cancer Care
🇺🇸East Brunswick, New Jersey, United States
Rutgers Cancer Institute of NJ
🇺🇸New Brunswick, New Jersey, United States
Montefiore Medical Center - Bronx
🇺🇸Bronx, New York, United States
Duke University
🇺🇸Durham, North Carolina, United States
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States
Oncology Hematology Care Incorporated
🇺🇸Cincinnati, Ohio, United States
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
The Ohio State University
🇺🇸Columbus, Ohio, United States
Oncology Associates of Oregon, PC
🇺🇸Eugene, Oregon, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
Allegheny Health Network
🇺🇸Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Baptist Cancer Center Memphis Thoracic
🇺🇸Memphis, Tennessee, United States
Sarah Cannon Research Institute
🇺🇸Nashville, Tennessee, United States
Texas Oncology - Dallas Fort Worth
🇺🇸Dallas, Texas, United States
US Oncology Research Investigational Products Center
🇺🇸Dallas, Texas, United States
Osaka International Cancer Institute
🇯🇵Osaka-shi, Osaka, Japan
University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Virginia Oncology Associates
🇺🇸Newport News, Virginia, United States
Virginia Commonwealth University Massey Cancer Center
🇺🇸Richmond, Virginia, United States
The Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Hospital Britanico de Buenos Aires
🇦🇷Caba, Buenos Aires, Argentina
Instituto Alexander Fleming
🇦🇷Capital Federal, Buenos Aires, Argentina
Fundacion Medica de Rio Negro y Neuquen
🇦🇷Cipolletti, Río Negro, Argentina
Exelsus Oncologia Clinica
🇦🇷San miguel de tucuman, Tucuman, Argentina
Fundacion Centro Oncológico Riojano Integral para la Investigación y Prevención del Cáncer
🇦🇷La Rioja, Argentina
Chris OBrien Lifehouse
🇦🇺Camperdown, New South Wales, Australia
Wollongong Hospital
🇦🇺Wollongong, New South Wales, Australia
Greenslopes Private Hospital
🇦🇺Greenslopes, Queensland, Australia
Cancer Research South Australia
🇦🇺Adelaide, South Australia, Australia
Monash Medical Centre
🇦🇺Clayton, Victoria, Australia
Sir Charles Gairdner Hospital
🇦🇺Nedlands, Western Australia, Australia
Medizinische Universitaet Graz
🇦🇹Graz, Austria
Universitaetsklinikum Krems
🇦🇹Krems, Austria
Landeskrankenhaus Feldkirch
🇦🇹Rankweil, Austria
Azorg Campus Aalst - Moorselbaan
🇧🇪Aalst, Belgium
Institut Jules Bordet
🇧🇪Brussels, Belgium
Universitair Ziekenhuis Brussel
🇧🇪Brussel, Belgium
Universite Catholique de Louvain Cliniques Universitaires Saint Luc
🇧🇪Bruxelles, Belgium
Universitair Ziekenhuis Antwerpen
🇧🇪Edegem, Belgium
Ziekenhuis Oost-Limburg
🇧🇪Genk, Belgium
Algemeen Ziekenhuis Maria Middelares
🇧🇪Gent, Belgium
Centres Hospitaliers Universitaires - Helora - Hopital de Mons - Site Kennedy
🇧🇪Mons, Belgium
Centre Hospitalier Universitaire-Universite Catholique de Louvain Namur-Site Godinne
🇧🇪Yvoir, Belgium
Hospital Sao Rafael-Idor
🇧🇷Salvador, Bahia, Brazil
Cenantron Centro Avançado de Tratamento Oncologico Ltda
🇧🇷Belo Horizonte, Minas Gerais, Brazil
Santa Casa de Misericordia de Passos
🇧🇷Passos, Minas Gerais, Brazil
Hospital Uopeccan
🇧🇷Cascavel, Paraná, Brazil
Hospital de Clinicas de Ijui
🇧🇷Ijui, Rio Grande Do Sul, Brazil
Hospital de Clinicas de Passo Fundo
🇧🇷Passo Fundo, Rio Grande Do Sul, Brazil
Irmandade da Santa Casa de Misericordia de Porto Alegre
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Fundacao Antonio Prudente AC Camargo Cancer Center
🇧🇷Sao Paulo, São Paulo, Brazil
Kindai University Hospital
🇯🇵Osakasayama-shi, Osaka, Japan
Saitama Medical University International Medical Center
🇯🇵Hidaka-shi, Saitama, Japan
Hospital Israelita Albert Einstein
🇧🇷Sao Paulo, São Paulo, Brazil
Oncoclinicas Rio de Janeiro S A
🇧🇷Rio de Janeiro, Brazil
Shizuoka Cancer Center
🇯🇵Sunto-gun, Shizuoka, Japan
London Health Sciences Centre
🇨🇦London, Ontario, Canada
CHU de Quebec Hopital de l Enfant Jesus
🇨🇦Quebec, Canada
Beijing Chaoyang Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Beijing Cancer Hospital
🇨🇳Beijing, China
Xinqiao Hospital
🇨🇳Chongqing, Chongqing, China
Fujian Cancer Hospital
🇨🇳Fuzhou, Fujian, China
The Second Attached Hospital Of Fujian Medical University
🇨🇳Quanzhou, Fujian, China
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China
Affiliated Hospital of Guilin Medical University
🇨🇳Guilin, Guangxi, China
Guangxi Medical University Affiliated Tumor Hospital
🇨🇳Nanning, Guangxi, China
Cangzhou Peoples Hospital
🇨🇳Cangzhou, Hebei, China
Hospital Universitari Vall d Hebron
🇪🇸Barcelona, Cataluña, Spain
Hospital Clinic i Provincial de Barcelona
🇪🇸Barcelona, Cataluña, Spain
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Cataluña, Spain
Institut Catala d Oncologia Hospitalet Hospital Duran i Reynals
🇪🇸Hospitalet de Llobregat, Cataluña, Spain
Hospital Universitari i Politecnic La Fe
🇪🇸Valencia, Comunidad Valenciana, Spain
Clinica Universidad de Navarra
🇪🇸Pamplona, Navarra, Spain
Hospital Universitario Ramon y Cajal
🇪🇸Madrid, Spain
Universitaetsspital Basel
🇨🇭Basel, Switzerland
Inselspital Bern
🇨🇭Bern, Switzerland
Ospedale Regionale di Bellinzona e Vali
🇨🇭Mendrisio, Switzerland
Kantonsspital St Gallen
🇨🇭Sankt Gallen, Switzerland
Kaohsiung Chang Gung Memorial Hospital
🇨🇳Kaohsiung, Taiwan
National Cheng Kung University Hospital
🇨🇳Tainan, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Ankara Bilkent Sehir Hastanesi
🇹🇷Ankara, Turkey
Bagcilar Medipol Mega Universite Hastanesi
🇹🇷Istanbul, Turkey
Izmir Katip Celebi Universitesi Ataturk Egitim ve Arastirma Hastanesi
🇹🇷Izmir, Turkey
Medical Park Seyhan Hastanesi
🇹🇷Mersin, Turkey
VM Medical Park Mersin Hastanesi
🇹🇷Mersin, Turkey
Sakarya Egitim ve Arastirma Hastanesi
🇹🇷Sakarya, Turkey