Study Evaluating Tarlatamab After Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer (LS-SCLC)
DeLLphi-306
A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Tarlatamab Therapy in Subjects With Limited-Stage Small-Cell Lung Cancer (LS-SCLC) Who Have Not Progressed Following Concurrent Chemoradiation Therapy
2 other identifiers
interventional
404
26 countries
202
Brief Summary
The primary objective of this study is to compare the efficacy of tarlatamab with placebo as assessed by progression free survival (PFS) based on blinded independent central review (BCIR) per response evaluation criteria in solid tumors v1.1 (RECIST 1.1) and on prolonging overall survival (OS).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2024
Longer than P75 for phase_3
202 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 31, 2023
CompletedFirst Posted
Study publicly available on registry
November 7, 2023
CompletedStudy Start
First participant enrolled
February 20, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 20, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 20, 2030
April 29, 2026
April 1, 2026
6.2 years
October 31, 2023
April 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
PFS as Determined by BICR
Up to approximately 6 years
OS Over the Whole Trial
Up to approximately 6 years
Secondary Outcomes (10)
PFS Determined by Investigator Assessment
Up to approximately 6 years
Complete Response (CR) Rate
Up to approximately 6 years
CR + non-CR/non-Progressive Disease (PD) Rate
Up to approximately 6 years
Duration of Complete Response
Up to approximately 6 years
PFS at 6 months, 1 year, 2 years
6 months, 1 year, 2 years
- +5 more secondary outcomes
Study Arms (2)
Tarlatamab
EXPERIMENTALParticipants will receive tarlatamab on Cycle 1 Day 1, 8 and 15, and once every 2 weeks (Q2W) thereafter (cycle is 28 days).
Placebo
PLACEBO COMPARATORParticipants will receive placebo on Cycle 1 Day 1, 8 and 15, and Q2W thereafter (cycle is 28 days).
Interventions
Eligibility Criteria
You may qualify if:
- Participant has provided informed consent prior to initiation of any study specific activities/procedures.
- Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years).
- Histologically or cytologically confirmed small-cell lung cancer (SCLC).
- Diagnosed and treated for LS-SCLC with concurrent chemotherapy and radiotherapy.
- Has completed chemoradiotherapy without progression per RECIST 1.1 (ie, achieved complete response \[CR\], partial response \[PR\], or stable disease \[SD\]).
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
- Minimum life expectancy of 12 weeks.
- Adequate organ function.
- Toxicities attributed to concurrent chemoradiotherapy resolved to grade ≤ 1, unless otherwise specified. Excluding alopecia or fatigue.
You may not qualify if:
- Disease Related
- Extensive-stage SCLC (ES-SCLC).
- Any previous diagnosis of transformed non-small-cell lung cancer (NSCLC), epidermal growth factor receptor (EGFR) activating mutation positive NSCLC that has transformed to SCLC, or mixed SCLC NSCLC histology.
- Evidence of interstitial lung disease or active, non-infectious pneumonitis. Other Medical Conditions
- History of other malignancy within the past 2 years, with certain exceptions.
- History of solid organ transplantation.
- Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association \> class II) within 6 months prior to first dose of study treatment.
- History of arterial thrombosis (eg, stroke or transient ischemic attack) within 6 months prior to first dose of study treatment.
- 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.
- Prior/Concomitant Therapy
- Received sequential chemotherapy and thoracic radiotherapy (no overlap of thoracic radiotherapy with chemotherapy) during chemoradiation.
- Prior therapy with any selective inhibitor of the delta-like ligand 3 (DLL3) pathway.
- Prior history of severe or life-threatening events from any immune-mediated therapy.
- Receiving another anti-cancer therapy. Adjuvant hormonal therapy for resected breast cancer is permitted.
- Receiving systemic corticosteroid therapy or any other form of immunosuppressive therapy within 7 days prior to enrollment.
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (204)
Valkyrie Clinical Trials
Los Angeles, California, 90067, United States
University of California Los Angeles
Santa Monica, California, 90404, United States
Yale New Haven Hospital
New Haven, Connecticut, 06510, United States
Boca Raton Clinical Research Global South Florida
Plantation, Florida, 33322, United States
University of Louisville James Graham Brown Cancer Center
Louisville, Kentucky, 40202, United States
Our Lady of the Lake Cancer Institute
Baton Rouge, Louisiana, 70808, United States
Morristown Medical Center
Morristown, New Jersey, 07960, United States
New York University Grossman School of Medicine and New York University Langone Hospitals
New York, New York, 10016, United States
Perlmutter Cancer Center at New York University Langone Hospital - Long Island
New York, New York, 10016, United States
Montefiore Einstein Center for Cancer Care
The Bronx, New York, 10461, United States
FirstHealth Cancer Center
Pinehurst, North Carolina, 28374, United States
Lehigh Valley Health Network
Allentown, Pennsylvania, 18103, United States
Spokenword Clinical Trials
Easton, Pennsylvania, 18045, United States
Renovatio Clinical
The Woodlands, Texas, 77380, United States
US Oncology Research Investigational Products Center
The Woodlands, Texas, 77380, United States
University of Virginia Health System
Charlottesville, Virginia, 22908, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031, United States
West Virginia University Health Sciences Center
Morgantown, West Virginia, 26506, United States
Fundacion Respirar
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1426ABP, Argentina
Hospital Italiano de La Plata
La Plata, Buenos Aires, 1900, Argentina
Hospital Universitario Austral
Pilar, Buenos Aires, B1629ODT, Argentina
Instituto Oncologico de Cordoba Ionc Fundacion Richardet Longo
Córdoba, Córdoba Province, 5003, Argentina
Hospital Aleman Buenos Aires
CABA, Distrito Federal, C1118AAT, Argentina
Clinica Viedma
Viedma, Río Negro Province, R8500ACE, Argentina
Sanatorio 9 de Julio Cice 9 de Julio
San Miguel de Tucumán, Tucumán Province, 4000, Argentina
Instituto Argentino de Diagnóstico y Tratamiento
Buenos Aires, C1122AAL, Argentina
Port Macquarie Base Hospital
Port Macquarie, New South Wales, 2444, Australia
Westmead Hospital
Westmead, New South Wales, 2145, Australia
Flinders Medical Centre
Bedford Park, South Australia, 5042, Australia
Monash Medical Centre
Clayton, Victoria, 3168, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, 6150, Australia
Medizinische Universitaet Graz
Graz, 8036, Austria
Universitaetsklinikum Allgemeines Krankenhaus Wien
Vienna, 1090, Austria
Institut Jules Bordet
Brussels, B-1070, Belgium
Universitair Ziekenhuis Gent
Ghent, 9000, Belgium
Hospital Santa Rita
Vitória, Espírito Santo, 29043-260, Brazil
Oncoclinicas Onco Vida Distrito Federal
Brasília, Federal District, 70200-730, Brazil
Liga Paranaense do Combate ao Cancer - Hospital Erasto Gaertner
Curitba, Paraná, 81520-060, Brazil
Londrina Cancer Hospital
Londrina, Paraná, 86015-520, Brazil
Liga Norte-Riograndense Contra O Cancer
Natal, Rio Grande do Norte, 59075-740, Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-003, Brazil
Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Cipo - Centro Integrado de Pesquisa em Oncologia
Porto Alegre, Rio Grande do Sul, 91350-200, Brazil
Centro de pesquisa em oncologia Hospital Ana Nery
Santa Cruz do Sul, Rio Grande do Sul, 96835-090, Brazil
Centro Catarinense de Pesquisa LTDA
Blumenau, Santa Catarina, 89015-200, Brazil
Fundacao pio xII Barretos
Barretos, São Paulo, 14784-400, Brazil
Fundacao Amaral Carvalho
Jaú, São Paulo, 17210-120, Brazil
Cepho
Santo André, São Paulo, 09060-650, Brazil
Instituto Dor de Pesquisa e Ensino
Rio de Janeiro, 22793-080, Brazil
Instituto Cancer Sao Paulo Icesp
São Paulo, 01246-000, Brazil
Multiprofile Hospital for Active Treatment - Uni Hospital OOD
Panagyurishte, 4500, Bulgaria
Complex Oncology Center Plovdiv EOOD
Plovdiv, 4004, Bulgaria
Complex Oncology Center Shumen EOOD
Shumen, 9700, Bulgaria
University Multiprofile Hospital for Active Treatment Sofiamed OOD
Sofia, 1113, Bulgaria
University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD
Sofia, 1527, Bulgaria
Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia
Sofia, 1606, Bulgaria
Multiprofile Hospital for Active Treatment Serdikamed EOOD
Sofia, 1632, Bulgaria
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, 400030, China
Fujian Cancer Hospital
Fuzhou, Fujian, 350014, China
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian, 350025, China
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, 510060, China
Henan Cancer Hospital
Zhengzhou, Henan, 450003, China
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060, China
Hubei Cancer Hospital
Wuhan, Hubei, 430070, China
Hunan Cancer Hospital
Changsha, Hunan, 410013, China
Northern Jiangsu Peoples hospital
Yangzhou, Jiangsu, 225009, China
Jiangxi Cancer hospital
Nanchang, Jiangxi, 330029, China
The First Bethune Hospital of Jilin University
Changchun, Jilin, 130021, China
Cancer Hospital of Shandong First Medical University
Jinan, Shandong, 250117, China
Qingdao Municipal Hospital
Qingdao, Shandong, 266000, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032, China
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, 030009, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, 030032, China
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, 300060, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830011, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003, China
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang, 315016, China
Zhejiang Taizhou Hospital
Taizhou, Zhejiang, 317099, China
Centro de Tratamiento e Investigación sobre Cancer Luis Carlos Sarmiento Angulo Ctic
Bogota, Cundinamarca, 0129, Colombia
Instituto Nacional de Cancerologia
Bogota, Cundinamarca, 111711, Colombia
Instituto Medico de Alta Tecnologia sas - Imat sas
Montería, Departamento de Córdoba, Colombia
Oncologos del Occidente SAS
Pereira, Risaralda Department, 660001, Colombia
Fundacion cardiovascular de Colombia
Bucaramanga, Santander Department, 681017, Colombia
Centre Hospitalier Régional Universitaire de Lille - Institut Coeur Poumon
Lille, 59037, France
Centre Hospitalier Universitaire Nord
Marseille, 13915, France
Centre Hospitalier Universitaire de Nice - Hopital Pasteur
Nice, 06002, France
Hopital Bichat Claude Bernard
Paris, 75018, France
Hopital Nord Ouest Villefranche sur Saone
Villefranche-sur-Saône, 69400, France
Universitaetsklinikum Essen
Essen, 45147, Germany
Universitaetsmedizin Goettingen
Göttingen, 37075, Germany
Universitaetsklinikum Wuerzburg
Würzburg, 97078, Germany
Agios Savvas Anticancer Hospital
Athens, 11522, Greece
Henry Dunant Hospital Center
Athens, 11526, Greece
Sotiria General Hospital
Athens, 11527, Greece
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
Athens, 12462, Greece
Metropolitan General
Athens, 15562, Greece
Metropolitan Hospital
Athens, 18547, Greece
Saint Luke Hospital
Thessaloniki, 55236, Greece
European Interbalkan Medical Center
Thessaloniki, 57001, Greece
Queen Mary Hospital, The University of Hong Kong
Hong Kong, Hong Kong
Prince of Wales Hospital, Chinese University of Hong Kong
Shatin, New Territories, Hong Kong
Centro di Riferimento Oncologico di Aviano
Aviano PN, 33081, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133, Italy
IRCCS Istituto Oncologico Europeo
Milan, 20141, Italy
Azienda Ospedaliera Universitaria San Luigi Gonzaga
Orbassano, 10043, Italy
Istituto Oncologico Veneto IRCCS
Padova, 35128, Italy
Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia
Perugia, 06156, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, 56124, Italy
Azienda Unita Sanitaria Locale di Reggio Emilia Arcispedale Santa Maria Nuova
Reggio Emilia, 42123, Italy
IRCCS Istituto Clinico Humanitas
Rozzano MI, 20089, Italy
Ospedale San Giuseppe Moscati
Statte, 74010, Italy
National Hospital Organization Nagoya Medical Center
Nagoya, Aichi-ken, 460-0001, Japan
National Cancer Center Hospital East
Kashiwa-shi, Chiba, 277-8577, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, 791-0280, Japan
Kurume University Hospital
Kurume-shi, Fukuoka, 830-0011, Japan
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido, 003-0804, Japan
Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center
Yokohama, Kanagawa, 241-8515, Japan
Sendai Kousei Hospital
Sendai, Miyagi, 981-0914, Japan
Niigata Cancer Center Hospital
Niigata, Niigata, 951-8566, Japan
Okayama University Hospital
Okayama, Okayama-ken, 700-8558, Japan
Kansai Medical University Hospital
Hirakata-shi, Osaka, 573-1191, Japan
Osaka International Cancer Institute
Osaka, Osaka, 541-8567, Japan
Kindai University Hospital
Osakasayama-shi, Osaka, 589-8511, Japan
Saitama Medical University International Medical Center
Hidaka-Shi, Saitama, 350-1298, Japan
Saitama Cancer Center
Kitaadachi-gun, Saitama, 362-0806, Japan
Shizuoka Cancer Center
Sunto-gun, Shizuoka, 411-8777, Japan
Dokkyo Medical University Hospital
Shimotsuga-gun, Tochigi, 321-0293, Japan
Juntendo University Hospital
Bunkyo-ku, Tokyo, 113-8431, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, 104-0045, Japan
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Koto-ku, Tokyo, 135-8550, Japan
Wakayama Medical University Hospital
Wakayama, 641-8509, Japan
Centro Oncologico Personalizado
Cuauhtémoc, Mexico City, 06760, Mexico
Oncare
Mexico City, Mexico City, 03810, Mexico
Oncocenter Clinica Integral Internacional de Oncologia
Puebla City, 72530, Mexico
Phylasis Clinicas Research Toluca
Toluca, 50090, Mexico
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, 15-540, Poland
Centrum Pulmonologii i Torakochirurgii w Bystrej
Bystra, 43-360, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-214, Poland
Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie
Lublin, 20-090, Poland
Wielkopolskie Centrum Pulmonologii i Torakochirurgii imienia Eugenii i Janusza Zeylandow
Poznan, 60-569, Poland
Szpital Specjalistyczny w Prabutach Spolka z Ograniczoną Odpowiedzialnoscia
Prabuty, 82-550, Poland
Wojewodzki Szpital im Sw Ojca Pio w Przemyslu
Przemyśl, 37-700, Poland
Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
Warsaw, 02-781, Poland
Unidade Local de Saude de Braga, EPE
Braga, 4710-243, Portugal
Hospital da Luz, SA
Lisbon, 1500-650, Portugal
Hospital Cuf porto
Porto, 4100-180, Portugal
Spitalul Clinic de Urgenta Prof Dr Agrippa Ionescu
Balotesti, Ilfov, 077015, Romania
Institutul Oncologic, Prof Dr Alexandru Trestioreanu
Bucharest, 022328, Romania
Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca
Cluj-Napoca, 400015, Romania
Centrul de Oncologie Sf Nectarie SRL
Craiova, 200542, Romania
Institutul Regional de Oncologie Iasi
Iași, 700483, Romania
Spitalul Municipal Ploiesti
Ploieşti, 100337, Romania
SC Oncomed SRL
Timișoara, 300239, Romania
National Cancer Centre Singapore
Singapore, 168583, Singapore
Icon - Mount Alvernia
Singapore, 217562, Singapore
Chungbuk National University Hospital
Cheongju Chungbuk, 28644, South Korea
National Cancer Center
Goyang-si Gyeonggi-do, 10408, South Korea
Gachon University Gil Medical Center
Incheon, 405-760, South Korea
Gyeongsang National University Hospital
Jinju, 52727, South Korea
Cha Bundang Medical Center, Cha University
Seongnam-si, Gyeonggi-do, 13496, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
Severance Hospital Yonsei University Health System
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Seoul National University Hospital
Seoul, 110-744, South Korea
Hospital Regional Universitario de Malaga
Málaga, Andalusia, 29011, Spain
Hospital Universitario Virgen del Rocio
Seville, Andalusia, 41013, Spain
Hospital Clinico Universitario Lozano Blesa
Zaragoza, Aragon, 50009, Spain
Hospital Universitario Insular de Gran Canaria
Las Palmas de Gran Canaria, Canary Islands, 35016, Spain
Institut Catala d Oncologia Badalona Hospital Universitari Germans Trias i Pujol
Badalona, Catalonia, 08916, Spain
Hospital del Mar
Barcelona, Catalonia, 08003, Spain
Hospital Universitari Vall d Hebron
Barcelona, Catalonia, 08035, Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, Catalonia, 08036, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, 08041, Spain
Hospital Clinico Universitario de Santiago
Santiago de Compostela, Galicia, 15706, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, 28222, Spain
Clinica Universidad de Navarra
Pamplona, Navarre, 31008, Spain
Instituto Valenciano de Oncologia
Valencia, Valencia, 46009, Spain
Hospital General Universitario Gregorio Maranon
Madrid, 28009, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Sahlgrenska Universitetssjukhuset
Gothenburg, 413 45, Sweden
Norrlands Universitetssjukhus
Umeå, 901 85, Sweden
Kantonsspital Baden
Baden, 5404, Switzerland
Universitaetsspital Basel
Basel, 4052, Switzerland
Ospedale Regionale di Bellinzona e Vali
Mendrisio, 6850, Switzerland
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 80756, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Ankara Etlik Sehir Hastanesi
Ankara, 06200, Turkey (Türkiye)
Memorial Ankara Hastanesi
Ankara, 06520, Turkey (Türkiye)
Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi
Ankara, 06560, Turkey (Türkiye)
Ankara Bilkent Sehir Hastanesi
Ankara, 06800, Turkey (Türkiye)
Bagcilar Medipol Mega Universite Hastanesi
Istanbul, 34214, Turkey (Türkiye)
Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi
Istanbul, 34722, Turkey (Türkiye)
Marmara Universitesi Tip Fakultesi Hastanesi
Istanbul, 34890, Turkey (Türkiye)
Dr Suat Seren Gogus Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi
Izmir, 35110, Turkey (Türkiye)
Izmir Ekonomi Universitesi Medical Point Hastanesi
Izmir, 35575, Turkey (Türkiye)
Kocaeli Universitesi Tip Fakultesi Hastanesi
Kocaeli, 41380, Turkey (Türkiye)
Medical Park Seyhan Hastanesi
Mersin, 33200, Turkey (Türkiye)
Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
Samsun, 55200, Turkey (Türkiye)
Guys Hospital
London, SE1 9RT, United Kingdom
Christie Hospital
Manchester, M20 4BX, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 31, 2023
First Posted
November 7, 2023
Study Start
February 20, 2024
Primary Completion (Estimated)
April 20, 2030
Study Completion (Estimated)
April 20, 2030
Last Updated
April 29, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
- Access Criteria
- Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.