Study Comparing Tarlatamab With Standard of Care Chemotherapy in Relapsed Small Cell Lung Cancer
DeLLphi-304
A Randomized, Open-label, Phase 3 Study of Tarlatamab Compared With Standard of Care in Subjects With Relapsed Small Cell Lung Cancer After Platinum-based First-line Chemotherapy
1 other identifier
interventional
509
30 countries
219
Brief Summary
The main objective is to compare the efficacy of tarlatamab with standard of care (SOC) 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 May 2023
Longer than P75 for phase_3
219 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
February 7, 2023
CompletedFirst Posted
Study publicly available on registry
February 23, 2023
CompletedStudy Start
First participant enrolled
May 31, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 29, 2025
CompletedResults Posted
Study results publicly available
January 5, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 26, 2028
ExpectedJanuary 5, 2026
November 1, 2025
1.7 years
February 7, 2023
December 12, 2025
December 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival (OS)
OS was defined as time from randomization until death from any cause. Median overall survival was estimated using Kaplan-Meier method. 95% confidence intervals (CIs) were calculated using the Brookmeyer and Crowley method.
From randomization up to minimum of death or primary completion DCO date 29 January 2025; median (min, max) time on the study was 8.6 (0.1, 18.5) months
Secondary Outcomes (18)
Progression Free Survival (PFS)
Up to approximately 4 years
Change From Baseline in Selected Functional Scales and Disease Symptom Items Included in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Up to approximately 4 years
Change From Baseline in Selected Disease Symptoms Included in the European Organization for Research and Treatment of Lung Cancer Quality of Life Questionnaire (EORTC-QLQ-LC13)
Up to approximately 4 years
Objective Response Rate (ORR)
Up to approximately 4 years
Disease Control Rate (DCR)
Up to approximately 4 years
- +13 more secondary outcomes
Study Arms (2)
Tarlatamab
EXPERIMENTALParticipants will receive tarlatamab as an intravenous (IV) infusion.
Standard of Care
ACTIVE COMPARATORParticipants will receive treatment per local standard of care (SOC).
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 adult age within country, whichever is older) at the time of signing the informed consent.
- Histologically or cytologically confirmed SCLC with demonstrated progression or relapse.
- Participants who progressed or recurred following 1 platinum-based regimen.
- Measurable disease as defined per RECIST 1.1 within the 21-day screening period.
- Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1.
- Minimum life expectancy of 12 weeks.
- Adequate organ function.
You may not qualify if:
- Disease Related
- Symptomatic central nervous system (CNS) metastases with exceptions defined in the protocol.
- Diagnosis or evidence of leptomeningeal disease.
- Prior history of immune checkpoint inhibitors resulting in events defined in the protocol.
- Other Medical Conditions
- Active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy.
- History of solid organ transplantation.
- History of other malignancy within the past 2 years, with exceptions defined in the protocol.
- Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association \> class II) within 12 months prior to first dose of study treatment.
- History of arterial thrombosis (eg, stroke or transient ischemic attack) within 12 months prior to first dose of study treatment.
- Presence or history of viral infection based on criteria per protocol.
- Receiving systemic corticosteroid therapy or any other form of immunosuppressive therapy within 7 days prior to first dose of study treatment.
- Symptoms and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection requiring antibiotics within 7 days prior to the first dose study treatment.
- Evidence of interstitial lung disease or active, non-infectious pneumonitis.
- Prior/Concomitant Therapy
- +27 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (223)
University of South Alabama Mitchell Cancer Institute
Mobile, Alabama, 36604, United States
Alaska Oncology and Hematology
Anchorage, Alaska, 99508, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
University of California Los Angeles
Santa Monica, California, 90404, United States
Northwestern University
Chicago, Illinois, 60611, United States
University of Illinois Chicago
Chicago, Illinois, 60612, United States
Indiana University
Indianapolis, Indiana, 46202, United States
University of Iowa
Iowa City, Iowa, 52242, United States
Pikeville Medical Center
Pikeville, Kentucky, 41501, United States
Our Lady of the Lake Cancer Institute
Baton Rouge, Louisiana, 70808, United States
Trinity Health Saint Joseph Mercy Ann Arbor
Ann Arbor, Michigan, 48106, United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455, United States
University of Missouri Health Care
Columbia, Missouri, 65212, United States
Summit Medical Group, Overlook Oncology Center
Summit, New Jersey, 91010, 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
Memorial Sloan Kettering Cancer Center
New York, New York, 10021, United States
Northport Veterans Affairs Medical Center
Northport, New York, 11768, United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58102, United States
Sanford Oncology Clinic and Pharmacy
Sioux Falls, South Dakota, 57104, United States
University of Tennessee Medical Center Knoxville
Knoxville, Tennessee, 37920, United States
Baptist Cancer Center
Memphis, Tennessee, 38120, United States
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
Swedish Cancer Institute Medical Oncology
Edmonds, Washington, 98026, United States
The Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Cemic
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1431FWO, Argentina
Hospital Universitario Austral
Pilar, Buenos Aires, B1629ODT, Argentina
Sociedad de Beneficencia Hospital Italiano
Córdoba, Córdoba Province, X5004BAL, Argentina
Clinica Viedma
Viedma, Río Negro Province, R8500ACE, Argentina
Sanatorio Parque SA
Rosario, Santa Fe Province, 2000, Argentina
Instituto Argentino de Diagnostico y Tratamiento IADT
Buenos Aires, C1122AAL, Argentina
Sanatorio Allende
Córdoba, X5000JHQ, Argentina
Liverpool Hospital
Liverpool, New South Wales, 2170, Australia
Calvary Mater Newcastle Hospital
Waratah, New South Wales, 2298, Australia
Monash Medical Centre
Clayton, Victoria, 3168, Australia
The Alfred Hospital
Melbourne, Victoria, 3004, Australia
Medizinische Universitaet Graz
Graz, 8036, Austria
Universitaetsklinikum Krems
Krems, 3500, Austria
Universitair Ziekenhuis Gent
Ghent, 9000, Belgium
Jessa Ziekenhuis - Campus Virga Jesse
Hasselt, 3500, Belgium
AZ Delta Campus Rumbeke
Roeselare, 8800, Belgium
Vitaz campus Sint-Niklaas Moerland
Sint-Niklaas, 9100, Belgium
Hospital Santa Izabel
Salvador, Estado de Bahia, 40050-410, Brazil
Instituto de Ensino e Pesquisa do Hospital da Bahia
Salvador, Estado de Bahia, Brazil
Liga Norte-Riograndense Contra O Cancer
Natal, Rio Grande do Norte, 59075-740, Brazil
Oncosite Centro de Pesquisa Clinica Em Oncologia Ltda
Ijuí, Rio Grande do Sul, 98700-000, Brazil
Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Hospital de Amor da Amazonia
Porto Velho, Rondônia, 76834-899, Brazil
Hospital de Base de Sao Jose do Rio Preto
São José do Rio Preto, São Paulo, 15090-000, Brazil
Beneficencia Portuguesa de Sao Paulo - Bp
São Paulo, São Paulo, 01323-900, Brazil
Oncologia Rede D Or
São Paulo, São Paulo, 04502-001, Brazil
Instituto Coi
Rio de Janeiro, 22793-080, Brazil
Instituto do Cancer do Estado de Sao Paulo Octavio Frias de Oliveira Icesp
São Paulo, 01246-000, Brazil
London Health Sciences Centre
London, Ontario, N6A 5W9, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
Anhui Chest Hospital
Hefei, Anhui, 230022, China
Beijing Tongren Hospital affiliated to Capital Medical University
Beijing, Beijing Municipality, 100010, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
The Second Affiliated Hospital of Army Medical University, PLA
Chongqing, Chongqing Municipality, 400037, China
Army Special Medical Center of Peoples Liberation Army
Chongqing, Chongqing Municipality, 400042, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001, China
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian, 350025, China
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, 510060, China
Jiangmen Central Hospital
Jiangmen, Guangdong, 529030, China
The 4th Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000, China
Affiliated Cancer Hospital of Harbin Medical University
Harbin, Heilongjiang, 150000, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
Hunan Cancer Hospital
Changsha, Hunan, 410013, China
Subei Peoples Hospital
Yangzhou, Jiangsu, 225009, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
Jilin Cancer Hospital
Changchun, Jilin, 130012, China
Jinan Central Hospital
Jinan, Shandong, 250013, China
Shandong Tumor Hospital
Jinan, Shandong, 250117, China
Linyi Cancer Hospital
Linyi, Shandong, 276034, China
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032, China
Shanxi Province Cancer Hospital
Taiyuan, Shanxi, 30009, China
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041, China
The First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310005, China
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, 317099, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325015, China
Beijing Chest Hospital, Capital Medical University
Beijing, 101149, China
Fujian Cancer Hospital
Fuzhou, 350011, China
Tianjin Peoples Hospital
Tianjin, 300131, China
Weihai Municipal Hospital
Weihai, 264200, China
Fakultni nemocnice Brno
Brno, 625 00, Czechia
Masarykuv onkologicky ustav
Brno, 656 53, Czechia
Fakultni nemocnice Olomouc
Olomouc, 779 00, Czechia
Nemocnice Agel Ostrava-Vitkovice as
Ostrava-Vitkovice, 703 00, Czechia
Vseobecna fakultni nemocnice v Praze
Prague, 128 08, Czechia
Rigshospitalet
Copenhagen, 2100, Denmark
Centre Hospitalier Universitaire de Grenoble - Hopital Nord Michallon
Grenoble, 38700, France
Centre Hospitalier Régional Universitaire de Lille - Institut Coeur Poumon
Lille, 59037, France
Centre Hospitalier Regional Universitaire de Limoges - Hopital Dupuytren
Limoges, 87042, France
Centre Leon Berard
Lyon, 69008, France
Centre Hospitalier Universitaire Nord
Marseille, 13915, France
Institut Curie
Paris, 75005, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495, France
Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
Rennes, 35033, France
Centre Hospitalier Universitaire de Strasbourg - Nouvel Hopital Civil
Strasbourg, 67091, France
Centre Hospitalier Universitaire de Toulouse - Hopital Larrey
Toulouse, 31059, France
Gustave Roussy
Villejuif, 94805, France
Charite Universitaetsmedizin Berlin, Campus Virchow
Berlin, 13353, Germany
Universitaetsklinikum Koeln
Cologne, 50937, Germany
Universitaetsklinikum Dresden
Dresden, 01307, Germany
Universitaetsklinikum Essen
Essen, 45147, Germany
Asklepios Fachkliniken Muenchen Gauting
Gauting, 82130, Germany
LungenClinic Grosshansdorf GmbH
Großhansdorf, 22927, Germany
Robert-Bosch-Krankenhaus
Stuttgart, 70376, Germany
Universitaetsklinikum Wuerzburg
Würzburg, 97078, Germany
Saint Savas Hospital
Athens, 11522, Greece
Henry Dunant Hospital Center
Athens, 11526, Greece
Thoracic General Hospital Of Athens Sotiria
Athens, 11527, Greece
Alexandra Hospital
Athens, 11528, Greece
University Hospital of Heraklion
Heraklion - Crete, 71500, Greece
Olympion Therapeftirio General Clinic Of Patras
Pátrai, 26443, Greece
Saint Luke Hospital
Thessaloniki, 55236, Greece
European Interbalkan Medical Center
Thessaloniki, 57001, Greece
Semmelweis Egyetem
Budapest, 1083, Hungary
Orszagos Koranyi Pulmonologiai Intezet
Budapest, 1121, Hungary
Matrai Gyogyintezet
Gyöngyös, 3200, Hungary
Fejer Varmegyei Szent Gyorgy Egyetemi Oktato Korhaz
Székesfehérvár, 8000, Hungary
Komarom-Esztergom Varmegyei Szent Borbala Korhaz
Tatabánya, 2800, Hungary
Reformatus Pulmonologiai Centrum
Törökbálint, 2045, Hungary
Beaumont Hospital
Dublin, 9, Ireland
Rambam Medical Center
Haifa, 3109601, Israel
Hadassah Ein-Kerem Medical Center
Jerusalem, 9112001, Israel
Meir Medical Center
Kfar Saba, 4428164, Israel
Rabin Medical Center
Petah Tikva, 4941492, Israel
Humanitas Gavazzeni
Bergamo, 24125, Italy
Azienda Ospedaliera Universitaria Renato Dulbecco
Catanzaro, 88100, Italy
Ospedale Policlinico San Martino IRCCS
Genova, 16132, Italy
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori
Meldola (FC), 47014, Italy
Azienda Ospedaliera Universitaria San Luigi Gonzaga
Orbassano, 10043, Italy
Azienda Ospedaliera San Giovanni Addolorata
Roma, 00144, Italy
National Hospital Organization Nagoya Medical Center
Nagoya, Aichi-ken, 460-0001, Japan
Aichi Cancer Center
Nagoya, Aichi-ken, 464-8681, 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
Hyogo Cancer Center
Akashi-shi, Hyōgo, 673-8558, 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
Shizuoka Cancer Center
Sunto-gun, Shizuoka, 411-8777, 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, Wakayama, 641-8510, Japan
University Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur, 59100, Malaysia
Hospital Tengku Ampuan Afzan
Kuantan, Pahang, 25100, Malaysia
Sarawak General Hospital
Kuching, Sarawak, 93586, Malaysia
coi Centro Oncologico Internacional sapi de cv
Tlajomulco de Zúñiga, Jalisco, 45640, Mexico
Health Pharma Professional Research SA de CV
Mexico City, Mexico City, 03100, Mexico
Oncare
Mexico City, Mexico City, 03810, Mexico
Universitair Medisch Centrum Groningen
Groningen, 9713 GZ, Netherlands
Leids Universitair Medisch Centrum
Leiden, 2333 ZA, Netherlands
Erasmus Medisch Centrum
Rotterdam, 3015 GD, Netherlands
Universitair Medisch Centrum Utrecht
Utrecht, 3584 CX, Netherlands
Centrum Pulmonologii i Torakochirurgii w Bystrej
Bystra, 43-360, Poland
Szpital Specjalistyczny imienia Ludwika Rydygiera w Krakowie Sp zoo
Krakow, 31-826, Poland
Wielkopolskie Centrum Pulmonologii i Torakochirurgii imienia Eugenii i Janusza Zeylandow
Poznan, 60-569, Poland
Hospital da Luz, SA
Lisbon, 1500-650, Portugal
Hospital Cuf Descobertas
Lisbon, 1998-018, Portugal
Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano
Matosinhos Municipality, 4464-513, Portugal
Hospital Cuf porto
Porto, 4100-180, Portugal
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
SC Oncomed SRL
Timișoara, 300239, Romania
National Cancer Centre Singapore
Singapore, 168583, Singapore
Tan Tock Seng Hospital
Singapore, 308433, Singapore
Chungbuk National University Hospital
Cheongju Chungbuk, 28644, South Korea
National Cancer Center
Goyang-si Gyeonggi-do, 10408, South Korea
Gachon University Gil Hospital
Incheon, 21565, South Korea
Gyeongsang National University Hospital
Jinju, 52727, 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
The Catholic University of Korea Seoul St Marys Hospital
Seoul, 06591, South Korea
Ulsan University Hospital
Ulsan, 44033, South Korea
Hospital Regional Universitario de Malaga
Málaga, Andalusia, 29011, Spain
Hospital Clinico Universitario Lozano Blesa
Zaragoza, Aragon, 50009, Spain
Hospital del Mar
Barcelona, Catalonia, 08003, Spain
Hospital Universitari Vall d Hebron
Barcelona, Catalonia, 08035, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, 08041, Spain
Complexo Hospitalario Universitario A Coruna Hospital Teresa Herrera
A Coruña, Galicia, 15006, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, 28222, Spain
Fundacion Jimenez Diaz
Madrid, 28040, Spain
Hospital Clinico San Carlos
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Kantonsspital Graubuenden
Chur, 7000, Switzerland
Freiburg Spital
Fribourg, 1708, Switzerland
Hopitaux universitaires de Geneve
Geneva, 1211, Switzerland
Kantonsspital Sankt Gallen
Sankt Gallen, 9007, Switzerland
Kantonsspital Winterthur
Winterthur, 8401, Switzerland
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 80756, Taiwan
Veterans General Hospital - Taichung
Taichung, 40705, Taiwan
National Cheng Kung University Hospital
Tainan, 70403, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
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)
Pamukkale Universitesi Tip Fakultesi Hastanesi
Denizli, 20070, Turkey (Türkiye)
Bagcilar Medipol Mega Universite Hastanesi
Istanbul, 34214, Turkey (Türkiye)
Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi
Istanbul, 34722, Turkey (Türkiye)
Ege Universitesi Tip Fakultesi Hastanesi
Izmir, 35100, Turkey (Türkiye)
Izmir Ekonomi Universitesi Medical Point Hastanesi
Izmir, 35575, Turkey (Türkiye)
Inonu Universitesi Turgut Ozal Tip Merkezi
Malatya, 44280, Turkey (Türkiye)
University College London Hospital
London, NW1 2PG, United Kingdom
Guys Hospital
London, SE1 9RT, United Kingdom
Christie Hospital
Manchester, M20 4BX, United Kingdom
Related Publications (2)
Mountzios G, Sun L, Cho BC, Demirci U, Baka S, Gumus M, Lugini A, Zhu B, Yu Y, Korantzis I, Han JY, Ciuleanu TE, Ahn MJ, Rocha P, Mazieres J, Lau SCM, Schuler M, Blackhall F, Yoshida T, Owonikoko TK, Paz-Ares L, Jiang T, Hamidi A, Gauto D, Recondo G, Rudin CM; DeLLphi-304 Investigators. Tarlatamab in Small-Cell Lung Cancer after Platinum-Based Chemotherapy. N Engl J Med. 2025 Jul 24;393(4):349-361. doi: 10.1056/NEJMoa2502099. Epub 2025 Jun 2.
PMID: 40454646BACKGROUNDAhn MJ, Cho BC, Felip E, Korantzis I, Ohashi K, Majem M, Juan-Vidal O, Handzhiev S, Izumi H, Lee JS, Dziadziuszko R, Wolf J, Blackhall F, Reck M, Alvarez JB, Hummel HD, Dingemans AC, Sands J, Akamatsu H, Owonikoko TK, Ramalingam SS, Borghaei H, Johnson ML, Huang S, Mukherjee S, Minocha M, Jiang T, Martinez P, Anderson ES, Paz-Ares L. Plain language summary: tarlatamab for patients with previously treated small cell lung cancer. Future Oncol. 2024 Dec;20(40):3355-3364. doi: 10.1080/14796694.2024.2402152. Epub 2024 Nov 12.
PMID: 39530627DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Amgen Inc.
Study Officials
- STUDY DIRECTOR
MD
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
February 7, 2023
First Posted
February 23, 2023
Study Start
May 31, 2023
Primary Completion
January 29, 2025
Study Completion (Estimated)
March 26, 2028
Last Updated
January 5, 2026
Results First Posted
January 5, 2026
Record last verified: 2025-11
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