A Phase 2, Open-label, Randomized, Multicenter Study of Tarlatamab Dosing Regimens in Subjects With Small Cell Lung Cancer (SCLC) (DeLLphi-309)
Status: Recruiting
Location: See all (75) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The primary objective of this study is to describe the antitumor activity of tarlatamab in participants with small cell lung cancer (SCLC).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:
• 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 as described per protocol.
Locations
United States
California
University of California Los Angeles
RECRUITING
Los Angeles
Florida
AdventHealth Hematology and Oncology
RECRUITING
Orlando
Illinois
City of Hope Chicago
RECRUITING
Rockford
Minnesota
Health Partners Cancer Center at Regions Hospital
RECRUITING
Saint Paul
North Carolina
Duke University
RECRUITING
Durham
FirstHealth Cancer Center
RECRUITING
Pinehurst
New York
New York Oncology Hematology PC
RECRUITING
Albany
Pennsylvania
Guthrie Medical Group
RECRUITING
Sayre
Virginia
Virginia Cancer Specialists PC
RECRUITING
Fairfax
Other Locations
Argentina
Fundacion Respirar
RECRUITING
Ciudad Autonoma De Buenos Aires
Instituto de Investigaciones clinicas de Mar del Plata
RECRUITING
Mar Del Plata
Australia
Monash Medical Centre
RECRUITING
Clayton
Austin Health, Austin Hospital
RECRUITING
Heidelberg
Belgium
Grand Hopital de Charleroi - Site des Viviers
RECRUITING
Charleroi
Universitair Ziekenhuis Antwerpen
RECRUITING
Edegem
Jessa Ziekenhuis - Campus Virga Jesse
RECRUITING
Hasselt
Brazil
Hospital de Amor
RECRUITING
Barretos
Liga Norte-Riograndense Contra O Cancer
RECRUITING
Natal
Cipo - Centro Integrado de Pesquisa em Oncologia
RECRUITING
Porto Alegre
Hospital de Clinicas de Porto Alegre
RECRUITING
Porto Alegre
Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul
RECRUITING
Porto Alegre
Hospital de Base de Sao Jose do Rio Preto
RECRUITING
São José Do Rio Preto
China
Beijing Cancer Hospital
RECRUITING
Beijing
Peking Union Medical College Hospital
RECRUITING
Beijing
The Second Xiangya Hospital of Central South University
RECRUITING
Changsha
West China Hospital of Sichuan University
RECRUITING
Chengdu
Fujian Cancer Hospital
RECRUITING
Fuzhou
Mengchao Hepatobiliary Hospital of Fujian Medical University
RECRUITING
Fuzhou
Sun Yat-sen University Cancer Center
RECRUITING
Guangzhou
Sir Run Run Shaw Hospital
RECRUITING
Hangzhou
Affiliated Cancer Hospital of Harbin Medical University
RECRUITING
Harbin
Shanxi Bethune Hospital
RECRUITING
Taiyuan
Taizhou Hospital of Zhejiang Province
RECRUITING
Taizhou
Tianjin Medical University Cancer Institute and Hospital
RECRUITING
Tianjin
France
Hopital Lyon sud
RECRUITING
Pierre-bénite
Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
RECRUITING
Rennes
Hopital Foch
RECRUITING
Suresnes
Germany
Helios Kliniken Emil-von-Behring
RECRUITING
Berlin
Universitaetsklinikum des Saarlandes
RECRUITING
Homburg
Universitaetsklinikum Schleswig-Holstein - Kiel
RECRUITING
Kiel
Universitaetsklinikum Wuerzburg
RECRUITING
Würzburg
Greece
Alexandra Hospital
RECRUITING
Athens
Henry Dunant Hospital Center
RECRUITING
Athens
Metropolitan Hospital
RECRUITING
Athens
University Hospital of Heraklion
RECRUITING
Heraklion - Crete
University Hospital of Patras
RECRUITING
Pátrai
European Interbalkan Medical Center
RECRUITING
Thessaloniki
Italy
Azienda Ospedaliera San Giovanni Addolorata
RECRUITING
Roma
Japan
Kansai Medical University Hospital
RECRUITING
Hirakata-shi
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
RECRUITING
Koto-ku
Kurume University Hospital
RECRUITING
Kurume-shi
Niigata Cancer Center Hospital
RECRUITING
Niigata
Osaka International Cancer Institute
RECRUITING
Osaka
National Hospital Organization Hokkaido Cancer Center
RECRUITING
Sapporo
Shizuoka Cancer Center
RECRUITING
Sunto-gun
Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center
RECRUITING
Yokohama
Republic of Korea
Chungbuk National University Hospital
RECRUITING
Cheongju Chungbuk
Kyungpook National University Chilgok Hospital
RECRUITING
Daegu
Chonnam National University Hwasun Hospital
RECRUITING
Hwasun-gun, Jeollanam-do
Seoul National University Bundang Hospital
RECRUITING
Seongnam-si, Gyeonggi-do
Korea University Guro Hospital
RECRUITING
Seoul
Severance Hospital Yonsei University Health System
RECRUITING
Seoul
Spain
Complexo Hospitalario Universitario A Coruna Hospital Teresa Herrera
RECRUITING
A Coruña
Hospital Universitari Vall d Hebron
RECRUITING
Barcelona
Hospital Universitario Insular de Gran Canaria
RECRUITING
Las Palmas De Gran Canaria
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Hospital Universitario Ramon y Cajal
RECRUITING
Madrid
Switzerland
Kantonsspital Baden
RECRUITING
Baden
Universitaetsspital Zuerich
RECRUITING
Zurich
Turkey
Baskent Universitesi Adana Doktor Turgut Noyan Uygulama ve Arastirma Merkezi
RECRUITING
Adana
Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi
RECRUITING
Ankara
Memorial Ankara Hastanesi
RECRUITING
Ankara
Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi
RECRUITING
Istanbul
Ege Universitesi Tip Fakultesi Hastanesi
RECRUITING
Izmir
United Kingdom
Christie Hospital
RECRUITING
Manchester
Contact Information
Primary
Amgen Call Center
medinfo@amgen.com
866-572-6436
Time Frame
Start Date: 2025-02-26
Estimated Completion Date: 2029-02-13
Participants
Target number of participants: 240
Treatments
Experimental: Treatment Arm A: Dose 1 Tarlatamab
Participants will receive dose 1 of Tarlatamab by intravenous (IV) infusion during the treatment period.
Experimental: Treatment Arm B: Dose 2 Tarlatamab
Participants will receive dose 2 of Tarlatamab by IV infusion during the treatment period.
Experimental: Treatment Arm C: Dose 3 Tarlatamab
Participants will receive dose 3 of Tarlatamab by IV infusion during the treatment period.
Related Therapeutic Areas
Sponsors
Leads: Amgen