A Randomized, Open-Label, Phase 3 Study of ZL-1310, a DLL3 Antibody-Drug Conjugate (ADC), Compared to Investigator's Choice Therapy in Participants With Relapsed Small Cell Lung Cancer
Status: Recruiting
Location: See all (153) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The purpose of this study is to evaluate the efficacy and safety of ZL-1310 compared to Investigator's Choice Therapy in participants with relapsed Small Cell Lung Cancer.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Age \>/= 18 years, or considered an adult by local regulations, at the time of consent
• Signed informed consent
• Histologically or cytologically confirmed SCLC. Received 1L platinum-based systemic therapy and had documented disease progression during or after the most recent systemic therapy. Or received 2L tarlatamab is allowed.
• Measurable disease according to RECIST v1.1 as assessed by the investigator.
• Participants with a history of treated and stable or untreated and asymptomatic CNS metastases based on criteria per protocol.
• Adequate organ and marrow function
• Eastern Cooperative Group (ECOG) performance status of 0 or 1
• Life expectancy of at least 3 months
• Participants must be willing to undergo a tumor biopsy or provide archived tumor tissue sample at Screening
• Participants must be willing and able to comply with protocol for the duration of the study
Locations
United States
California
University of California San Diego
RECRUITING
La Jolla
UC Davis Comprehensive Cancer Center
RECRUITING
Sacramento
Colorado
University of Colorado
RECRUITING
Aurora
Connecticut
Yale Cancer Center/Clinical Trials Office
RECRUITING
New Haven
Florida
Clermont Oncology Center
RECRUITING
Clermont
Mid Florida Hematology and Oncology Center
RECRUITING
Orange City
Cancer Centers of Bevard
RECRUITING
Rockledge
Sarah Cannon Research Institute
RECRUITING
Sarasota
Florida Cancer Specialists - North
RECRUITING
St. Petersburg
Moffitt Cancer Center
RECRUITING
Tampa
Florida Cancer Specialists - East
RECRUITING
West Palm Beach
Iowa
University of Iowa
RECRUITING
Iowa City
University of Iowa Mission Health Cancer + Blood
RECRUITING
Waukee
Illinois
Illinois Cancer Care
RECRUITING
Peoria
OSF St. Francis Medical Center
RECRUITING
Peoria
Kentucky
Norton Cancer Institute
RECRUITING
Louisville
Maryland
American Oncology Partners, PA - The Center for Cancer and Blood Disorders
RECRUITING
Bethesda
Maryland Oncology Hematology
RECRUITING
Silver Spring
Michigan
Henry Ford Health Cancer
RECRUITING
Detroit
Missouri
Missouri Cancer Associates
RECRUITING
Columbia
Mercy South
RECRUITING
St Louis
New York
Stony Brook Cancer Center
RECRUITING
Stony Brook
Montefiore Medical Center
RECRUITING
The Bronx
Ohio
Cleveland Clinic - Akron General Medical Center
RECRUITING
Akron
Cleveland Clinic
RECRUITING
Cleveland
Cleveland Clinic - Fairview Hospital Molly Pavilion
RECRUITING
Cleveland
University Hospitals Cleveland Medical Center
RECRUITING
Cleveland
Cleveland Clinic - Hillcrest Hospital Cancer Center
RECRUITING
Mayfield Heights
Pennsylvania
Consultants in Medical Oncology and Hematology
RECRUITING
Broomall
Alliance Cancer Specialists
RECRUITING
Media
Allegheny General Hospital
RECRUITING
Pittsburgh
University of Pittsburgh (UPMC) Hillman Cancer Center
RECRUITING
Pittsburgh
Tennessee
SCRI OP (Oncology Partners)
RECRUITING
Nashville
Texas
Texas Oncology - Central South
RECRUITING
Austin
University of Texas Southwestern Medical Center/Clinical Research Department
RECRUITING
Dallas
Texas Oncology - West Texas
RECRUITING
Odessa
Virginia
Virginia Cancer Specialists
RECRUITING
Fairfax
Other Locations
Austria
Uniklinikum Salzburg, Landeskrankenhaus, Universitatsklinik fur Innere Medizin III der PMU Department of Internal Medicine III
RECRUITING
Salzburg
Belgium
Universitair Ziekenhuis Antwerpen
RECRUITING
Edegem
Algemeen Ziekenhuis Sint-Lucas
RECRUITING
Ghent
AZ Maria Middelares - Campus AZ Maria Middelares
RECRUITING
Ghent
Jessa Ziekenhuis Salvador
RECRUITING
Hasselt
Universitair Ziekenhuis Brussel
RECRUITING
Jette
AZ Groeninge
RECRUITING
Kortrijk
Vivalia St Joseph
RECRUITING
Libramont
Universite Catholique de Louvain Namur, Centre Hospitalier Universitaire Dinant Godinne
RECRUITING
Yvoir
China
Beijing Cancer Hospital
RECRUITING
Beijing
Cancer Hospital Chinese Academy of Medical Sciences
RECRUITING
Beijing
Jilin Cancer Hospital
RECRUITING
Changchun
Hunan Cancer Hospital
RECRUITING
Changsha
Sichuan Cancer Hospital
RECRUITING
Chengdu
Fujian Cancer Hospital
RECRUITING
Fuzhou
Guangdong Provincial People's Hospital
RECRUITING
Guangzhou
Zhejiang Cancer Hospital
RECRUITING
Hangzhou
Anhui Provincial Hospital
RECRUITING
Hefei
Harbin Medical University Cancer Hospital
RECRUITING
Heilongjiang
Shandong Cancer Hospital
RECRUITING
Jinan
Linyi Cancer Hospital
RECRUITING
Linyi
Jiangxi Cancer Hospital
RECRUITING
Nanchang
Guangxi Medical University Affiliated Tumor Hospital
RECRUITING
Naning
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
RECRUITING
Nanjing
Shanghai Pulmonary Hospital
RECRUITING
Shanghai
Fourth Hospital of Hebei Medical University
RECRUITING
Shijiazhuang
Taizhou Hospital of Zhejiang Province
RECRUITING
Taizhou
Hubei Cancer Hospital
RECRUITING
Wuhan
The First Affiliated Hospital of Xi'an Jiaotong University
RECRUITING
Xi'an
The First Affiliated Hospital of Xiamen University
RECRUITING
Xiamen
Henan cancer Hospital
RECRUITING
Zhengzhou
The First Affiliated Hospital of Zhengzhou University
RECRUITING
Zhengzhou
France
Institut Sainte Catherine
RECRUITING
Avignon
Hospices Civils de Lyon - Hopital Louis Pradel
RECRUITING
Bron
Centre Hospitalier Intercommunal de Creteil (CHIC) - Centre de ressources et de competences pour la mucoviscidose (C.R.C.M.)
RECRUITING
Créteil
Centre Hospitalier - Le Mans
RECRUITING
Le Mans
Centre Hospitalier Universitaire (CHU) De Limoges Hopital Dupuytren
RECRUITING
Limoges
Centre de Recherche Clinique Hôpital de la Croix-Rousse
RECRUITING
Lyon
Centre Hospitalier Regional Universitaire (CHRU) Montpellier Arnaud de Villeneuve
RECRUITING
Montpellier
Centre Hospitalier Lyon-Sud, CHLS
RECRUITING
Pierre-bénite
Centre Hospitalier de Cornouaille - Hopital Laennec
RECRUITING
Quimper
Hopital Foch
RECRUITING
Suresnes
Centre Hospitalier Intercommunal Toulon La Seyne Sur Mer (C.H.I.T.S) - Hospital Font-Pre
RECRUITING
Toulon
Clinique Teissier
RECRUITING
Valenciennes
Germany
Evangelische Lungenklinik Berlin
RECRUITING
Berlin
University Hospital Carl Gustav Carus
RECRUITING
Dresden
Klinikum der Johann Wolfgang Goethe-Universität
RECRUITING
Frankfurt Am Main
Krankenhaus Martha-Maria Halle-Doelau gGmbH
RECRUITING
Halle
Greece
Iatriko Diavalkaniko Thessalonikis
RECRUITING
Thessaloniki
Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I
RECRUITING
Ancona
FPO IRCCS Candiolo
RECRUITING
Candiolo
IRCCS Istituto Romagnolo per lo studio dei Tumori Dino Amadori(IRST)
RECRUITING
Meldola
AUSL Della Romagna - Ospedale S.Maria delle Croci
RECRUITING
Ravenna
Istituti Fisioterapici Ospitalieri (IFO) - Istituto Nazionale Tumori Regina Elena (IRE) UO Oncologia Ospedali Civili di Livorno
RECRUITING
Roma
Centro Ricerche Cliniche di Verona s.r.l.
RECRUITING
Verona
Japan
Asahikawa Medical University Hospital
RECRUITING
Asahikawa
Komagome Hospital
RECRUITING
Bunkyō-ku
Nippon Medical School Hospital
RECRUITING
Bunkyō-ku
Kyushu Medical Center
RECRUITING
Fukuoka
Kyushu University Hospital
RECRUITING
Fukuoka
Kansai Medical University Hospital
RECRUITING
Hirakata
Hiroshima University Hospital
RECRUITING
Hiroshima
Izumi City General Hospital
RECRUITING
Izumi
Nara Medical University Hospital
RECRUITING
Kashihara
Dokkyo Medical University Saitama Medical Center
RECRUITING
Koshigaya
The Cancer Institute Hospital of JFCR
RECRUITING
Koto-ku
Kurume University Hospital
RECRUITING
Kurume
Shinshu University Hospital
RECRUITING
Matsumoto
National Hospital Organization Nagasaki Medical Center
RECRUITING
Ōmura
Osaka International Cancer Institute
RECRUITING
Osaka
Kinki Chuo Chest Medical Center
RECRUITING
Sakai
KKR Sapporo Medical Center
RECRUITING
Sapporo
Sendai Kousei Hospital
RECRUITING
Sendai
Dokkyo Medical University Hospital
RECRUITING
Shimosuga
National Center for Global Health and Medicine
RECRUITING
Shinjuku-ku
Shizuoka Cancer Center
RECRUITING
Shizuoka
Kanagawa Cancer Center
RECRUITING
Yokohama
Netherlands
Amphia Ziekenhuis
RECRUITING
Breda
Tergooi Ziekenhuizen
RECRUITING
Hilversum
Poland
Instytut MSF Sp. z o.o.
RECRUITING
Lodz
Med-Polonia Sp. z o.o.
RECRUITING
Poznan
Pratia S.A. , Pratia Poznan
RECRUITING
Poznan
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu
RECRUITING
Przemyśl
Wojskowy Instytut Medyczny,Centralny Szpital Kliniczny Ministerstwa Obronty Narodowej
RECRUITING
Siedlce
Wojskowy Instytut Medyczny
RECRUITING
Warsaw
Spain
Hospital Clinic de Barcelona (Hospital Clinic i Provincial)
RECRUITING
Barcelona
UOMI Cancer Center-Clinica Tres Torres
RECRUITING
Barcelona
Hospital General Universitario de Elche
RECRUITING
Elche
Institut Catala d'Oncologia GIRONA
RECRUITING
Girona
Hospital Universitario de Jerez
RECRUITING
Jerez De La Frontera
Clinica Universidad de Navarra - Madrid
RECRUITING
Madrid
Hospital Universitario La Paz
RECRUITING
Madrid
Hospital Universitario Ramon y Cajal
RECRUITING
Madrid
Hospital Quironsalud Malaga
RECRUITING
Málaga
Universidad de Navarra - Clínica Universidad de Navarra (CUN)
RECRUITING
Pamplona
Hospital Universitari Sant Joan De Reus, S.A
RECRUITING
Reus
Hospital Universitario Virgen del Rocio
RECRUITING
Seville
Hospital Universitario Virgen Macarena / Clinical Research Department
RECRUITING
Seville
Fundación Instituto Valenciano de Oncología
RECRUITING
Valencia
Turkey
Baskent University Adana Turgut Noyan Application and Research Center Kisla Health Campus
RECRUITING
Adana
Medical Park Seyhan Hospital
RECRUITING
Adana
Sakarya University - Faculty of Medicine
RECRUITING
Adapazarı
Ankara Bilkent City Hospital
RECRUITING
Ankara
Liv Hospital Ankara
RECRUITING
Ankara
Memorial Ankara Hospital
RECRUITING
Çankaya
Istanbul University Cerrahpasa Faculty of Medicine Hospital
RECRUITING
Fatih
Medical Park Florya Hospital
RECRUITING
Istanbul
Yeditepe University Hospital
RECRUITING
Istanbul
Istanbul Medeniyet University Medical Faculty
RECRUITING
Kadıköy
United Kingdom
Addenbrooke's Hospital - Cambridge University Hospitals NHS Foundation Trust
RECRUITING
Cambridge
Royal Marsden Hospital (RMH) - Royal Marsden NHS Foundation Trust
RECRUITING
Chelsea
Sarah Cannon Research Institute
RECRUITING
London
Nottingham University Hospitals NHS Trust - Nottingham City Hospital
RECRUITING
Nottingham
Royal Stoke University Hospital - University Hospitals of North Midlands NHS Trust
RECRUITING
Stoke-on-trent
Royal Marsden Hospital (Sutton) - Royal Marsden NHS Foundation Trus
RECRUITING
Sutton
New Cross Hospital
RECRUITING
Wolverhampton
Contact Information
Primary
ZL-1310-003 Study Team
study-ZL-1310-003@zailaboratory.com
650-360-1601
Time Frame
Start Date: 2025-11-30
Estimated Completion Date: 2028-11-30
Participants
Target number of participants: 480
Treatments
Experimental: Arm 1
ZL-1310 as a single agent
Active_comparator: Arm 2
Investigator's Choice of Therapy
Related Therapeutic Areas
Sponsors
Leads: Zai Lab (Shanghai) Co., Ltd.
Collaborators: Zai Lab (US) LLC