A Study of ZL-1310 Versus Investigator's Choice of Therapy in Participants With Relapsed Small Cell Lung Cancer (DLLEVATE)
DLLEVATE
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
1 other identifier
interventional
480
15 countries
155
Brief 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.
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 Nov 2025
Typical duration for phase_3
155 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 8, 2025
CompletedFirst Posted
Study publicly available on registry
October 20, 2025
CompletedStudy Start
First participant enrolled
November 30, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 30, 2028
September 14, 2026
September 1, 2026
2.6 years
October 8, 2025
September 10, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Confirmed objective response rate (ORR) assessed by Blinded Independent Central Review of ZL-1310 compared to Investigator's Choice Therapy (ICT)
up to 30 months
Overall survival of ZL-1310 compared to Investigator's Choice Therapy (ICT)
up to 30 months
Secondary Outcomes (9)
Duration of response (DoR) assessed by BICR and by the investigator per RECIST v1.1 of ZL-1310 compared to Investigator's Choice Therapy (ICT)
up to 30 months
Progression-free survival (PFS) assessed by BICR and by the investigator per RECIST v1.1 of ZL-1310 compared to Investigator's Choice Therapy (ICT)
up to 30 months
Confirmed ORR assessed by the investigator per RECIST v1.1 of ZL-1310 compared to Investigator's Choice Therapy (ICT)
up to 30 months
Time to response (TTR) assessed by BICR and by the investigator per RECIST v1.1 of ZL-1310 compared to Investigator's Choice Therapy (ICT)
up to 30 months
Confirmed CNS response assessed by BICR per Response Assessment in Neuro-Oncology for Brain Metastases (RANO-BM) of ZL-1310 compared to Investigator's Choice Therapy (ICT)
up to 30 months
- +4 more secondary outcomes
Study Arms (2)
Arm 1
EXPERIMENTALZL-1310 as a single agent
Arm 2
ACTIVE COMPARATORInvestigator's Choice of Therapy
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Received more than one line of systemic therapy for Extensive-Stage SCLC.
- Received any prior ADC with topoisomerase 1 inhibitor payload
- Participants with another known malignancy with exceptions defined in the protocol.
- History or suspected ILD/pneumonitis based on criteria per protocol
- Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses.
- Receipt of anti-cancer treatment known to treat cancers within 3 weeks before the first dose of study treatment.
- Prior radiotherapy before study treatment based on criteria per protocol
- Unresolved toxicity of Grade \>/= 2 from previous anti-cancer treatment, except for alopecia and skin pigmentation.
- Known infection or active infection defined in the protocol.
- Clinically significant active cardiovascular disease or history of arterial thromboembolic event within 6 months prior to the first dose of study treatment based on criteria per protocol.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zai Lab (Shanghai) Co., Ltd.lead
- Zai Lab (US) LLCcollaborator
Study Sites (155)
University of California San Diego
La Jolla, California, 92093, United States
UC Davis Comprehensive Cancer Center
Sacramento, California, 95817, United States
University of Colorado
Aurora, Colorado, 80045, United States
Yale Cancer Center/Clinical Trials Office
New Haven, Connecticut, 06519, United States
Clermont Oncology Center
Clermont, Florida, 34711, United States
Mid Florida Hematology and Oncology Center
Orange City, Florida, 32763, United States
Cancer Centers of Bevard
Rockledge, Florida, 32955, United States
Sarah Cannon Research Institute
Sarasota, Florida, 34232, United States
Florida Cancer Specialists - North
St. Petersburg, Florida, 33701-4553, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Florida Cancer Specialists - East
West Palm Beach, Florida, 33401, United States
Illinois Cancer Care
Peoria, Illinois, 61615, United States
OSF St. Francis Medical Center
Peoria, Illinois, 61637, United States
University of Iowa
Iowa City, Iowa, 52242, United States
University of Iowa Mission Health Cancer + Blood
Waukee, Iowa, 50263, United States
Norton Cancer Institute
Louisville, Kentucky, 40202, United States
American Oncology Partners, PA - The Center for Cancer and Blood Disorders
Bethesda, Maryland, 20817, United States
Maryland Oncology Hematology
Silver Spring, Maryland, 20904, United States
Henry Ford Health Cancer
Detroit, Michigan, 48202, United States
Missouri Cancer Associates
Columbia, Missouri, 65201, United States
Mercy South
St Louis, Missouri, 63128, United States
Stony Brook Cancer Center
Stony Brook, New York, 11794-7007, United States
Montefiore Medical Center
The Bronx, New York, 10461, United States
Cleveland Clinic - Akron General Medical Center
Akron, Ohio, 44302, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Cleveland Clinic - Fairview Hospital Molly Pavilion
Cleveland, Ohio, 44111, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Cleveland Clinic - Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio, 44124, United States
Consultants in Medical Oncology and Hematology
Broomall, Pennsylvania, 19008, United States
Alliance Cancer Specialists
Media, Pennsylvania, 19063, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
University of Pittsburgh (UPMC) Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
SCRI OP (Oncology Partners)
Nashville, Tennessee, 37203, United States
Texas Oncology - Central South
Austin, Texas, 78745, United States
University of Texas Southwestern Medical Center/Clinical Research Department
Dallas, Texas, 75390-9020, United States
Texas Oncology - West Texas
Odessa, Texas, 79761, United States
Virginia Cancer Specialists
Fairfax, Virginia, 22031, United States
Uniklinikum Salzburg, Landeskrankenhaus, Universitatsklinik fur Innere Medizin III der PMU Department of Internal Medicine III
Salzburg, 5020, Austria
Universitair Ziekenhuis Antwerpen
Edegem, 2650, Belgium
Algemeen Ziekenhuis Sint-Lucas
Ghent, 9000, Belgium
AZ Maria Middelares - Campus AZ Maria Middelares
Ghent, 9000, Belgium
Jessa Ziekenhuis Salvador
Hasselt, 3500, Belgium
Universitair Ziekenhuis Brussel
Jette, 1090, Belgium
AZ Groeninge
Kortrijk, 8500, Belgium
Vivalia St Joseph
Libramont, 6800, Belgium
Universite Catholique de Louvain Namur, Centre Hospitalier Universitaire Dinant Godinne
Yvoir, 5530, Belgium
Anhui Provincial Hospital
Hefei, Anhui, 230036, China
Fujian Cancer Hospital
Fuzhou, Fujian, 350014, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361000, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080, China
Guangxi Medical University Affiliated Tumor Hospital
Naning, Guangxi, 530021, China
Harbin Medical University Cancer Hospital
Heilongjiang, Harbin, 000000, China
Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
Hubei Cancer Hospital
Wuhan, Hubei, 430079, China
Hunan Cancer Hospital
Changsha, Hunan, 410031, China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
Jiangxi Cancer Hospital
Nanchang, Jiangxi, 330029, China
Jilin Cancer Hospital
Changchun, Jilin, 130012, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061, China
Shandong Cancer Hospital
Jinan, Shandong, 250117, China
Linyi Cancer Hospital
Linyi, Shandong, 276000, China
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433, China
Sichuan Cancer Hospital
Chengdu, Sichuan, 610041, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310000, China
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, 318000, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, 000000, China
Beijing Cancer Hospital
Beijing, 100142, China
Henan cancer Hospital
Zhengzhou, 450008, China
Nemocnice Horovice
Hořovice, 53002, Czechia
Nemocnice AGEL Ostrava-Vitkovice a. s.
Vítkovice, 74101, Czechia
Institut Sainte Catherine
Avignon, 84918, France
Hospices Civils de Lyon - Hopital Louis Pradel
Bron, 69677, France
Centre Hospitalier Intercommunal de Creteil (CHIC) - Centre de ressources et de competences pour la mucoviscidose (C.R.C.M.)
Créteil, 94010, France
Centre Hospitalier - Le Mans
Le Mans, 72037, France
Centre Hospitalier Universitaire (CHU) De Limoges Hopital Dupuytren
Limoges, 87042, France
Centre de Recherche Clinique Hôpital de la Croix-Rousse
Lyon, 69317, France
Centre Hospitalier Regional Universitaire (CHRU) Montpellier Arnaud de Villeneuve
Montpellier, 34295, France
Centre Hospitalier Lyon-Sud, CHLS
Pierre-Bénite, 69495, France
Centre Hospitalier de Cornouaille - Hopital Laennec
Quimper, 35033, France
Hopital Foch
Suresnes, 92151, France
Centre Hospitalier Intercommunal Toulon La Seyne Sur Mer (C.H.I.T.S) - Hospital Font-Pre
Toulon, 83000, France
Clinique Teissier
Valenciennes, 59300, France
Klinikum der Johann Wolfgang Goethe-Universität
Frankfurt am Main, Hesse, 60590, Germany
Evangelische Lungenklinik Berlin
Berlin, 10407, Germany
University Hospital Carl Gustav Carus
Dresden, 01307, Germany
Krankenhaus Martha-Maria Halle-Doelau gGmbH
Halle, 6120, Germany
Iatriko Diavalkaniko Thessalonikis
Thessaloniki, 57001, Greece
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I
Ancona, 60126, Italy
FPO IRCCS Candiolo
Candiolo, 20132, Italy
IRCCS Istituto Romagnolo per lo studio dei Tumori "Dino Amadori"(IRST)
Meldola, 47014, Italy
AUSL Della Romagna - Ospedale S.Maria delle Croci
Ravenna, 48121, Italy
Istituti Fisioterapici Ospitalieri (IFO) - Istituto Nazionale Tumori Regina Elena (IRE) UO Oncologia Ospedali Civili di Livorno
Roma, 00144, Italy
Centro Ricerche Cliniche di Verona s.r.l.
Verona, 37134, Italy
Kyushu Medical Center
Fukuoka, Fukuoka, 810-8563, Japan
Kyushu University Hospital
Fukuoka, Fukuoka, 812-8582, Japan
Kurume University Hospital
Kurume, Fukuoka, 830-0011, Japan
Hiroshima University Hospital
Hiroshima, Hiroshima, 734-8551, Japan
Asahikawa Medical University Hospital
Asahikawa, Hokkaido, 0788510, Japan
KKR Sapporo Medical Center
Sapporo, Hokkaido, 062-0931, Japan
Kanagawa Cancer Center
Yokohama, Kanagawa, 241-8515, Japan
Sendai Kousei Hospital
Sendai, Miyagi, 981-0914, Japan
Shinshu University Hospital
Matsumoto, Nagano, 390-8621, Japan
National Hospital Organization Nagasaki Medical Center
Ōmura, Nagasaki, 8568562, Japan
Nara Medical University Hospital
Kashihara, Nara, 634-8522, Japan
Kansai Medical University Hospital
Hirakata, Osaka, 573-1191, Japan
Izumi City General Hospital
Izumi, Osaka, 594-0073, Japan
Osaka International Cancer Institute
Osaka, Osaka, 541-8567, Japan
Kinki Chuo Chest Medical Center
Sakai, Osaka, 591-8555, Japan
Dokkyo Medical University Saitama Medical Center
Koshigaya, Saitama, 343-8555, Japan
Shizuoka Cancer Center
Shizuoka, Sunto-gun, 411-8777, Japan
Dokkyo Medical University Hospital
Shimosuga, Tochigi, 321-0293, Japan
Nippon Medical School Hospital
Bunkyō-Ku, Tokyo, 113-8603, Japan
Komagome Hospital
Bunkyō-Ku, Tokyo, 113-8677, Japan
The Cancer Institute Hospital of JFCR
Koto-Ku, Tokyo, 135-8550, Japan
National Center for Global Health and Medicine
Shinjuku-Ku, Tokyo, 162-8655, Japan
Amphia Ziekenhuis
Breda, 4818 CK, Netherlands
Tergooi Ziekenhuizen
Hilversum, 1261 AN, Netherlands
Instytut MSF Sp. z o.o.
Lodz, 90302, Poland
Pratia S.A. , Pratia Poznan
Poznan, 60-192, Poland
Med-Polonia Sp. z o.o.
Poznan, 60693, Poland
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu
Przemyśl, 37700, Poland
Wojskowy Instytut Medyczny,Centralny Szpital Kliniczny Ministerstwa Obronty Narodowej
Siedlce, 08-110, Poland
Wojskowy Instytut Medyczny
Warsaw, 04141, Poland
Fundación Instituto Valenciano de Oncología
Valencia, Valencia, 46009, Spain
UOMI Cancer Center-Clinica Tres Torres
Barcelona, 8017, Spain
Hospital Clinic de Barcelona (Hospital Clinic i Provincial)
Barcelona, 8036, Spain
Hospital General Universitario de Elche
Elche, 3203, Spain
Institut Catala d'Oncologia GIRONA
Girona, 17007, Spain
Hospital Universitario de Jerez
Jerez de la Frontera, 11404, Spain
Hospital Universitario Ramon y Cajal
Madrid, 28034, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Clinica Universidad de Navarra - Madrid
Madrid, 31008, Spain
Hospital Quironsalud Malaga
Málaga, 29010, Spain
Universidad de Navarra - Clínica Universidad de Navarra (CUN)
Pamplona, 31008, Spain
Hospital Universitari Sant Joan De Reus, S.A
Reus, 43204, Spain
Hospital Universitario Virgen Macarena / Clinical Research Department
Seville, 41009, Spain
Hospital Universitario Virgen del Rocio
Seville, 41013, Spain
Baskent University Adana Turgut Noyan Application and Research Center Kisla Health Campus
Adana, Adana, 1230, Turkey (Türkiye)
Ankara Bilkent City Hospital
Ankara, Ankara, 6800, Turkey (Türkiye)
Memorial Ankara Hospital
Çankaya, Ankara, 6520, Turkey (Türkiye)
Istanbul University Cerrahpasa Faculty of Medicine Hospital
Fatih, Istanbul, 34098, Turkey (Türkiye)
Istanbul Medeniyet University Medical Faculty
Kadıköy, Istanbul, 34720, Turkey (Türkiye)
Sakarya University - Faculty of Medicine
Adapazarı, Sakarya, 54290, Turkey (Türkiye)
Medical Park Seyhan Hospital
Adana, 1060, Turkey (Türkiye)
Liv Hospital Ankara
Ankara, 6680, Turkey (Türkiye)
Medical Park Florya Hospital
Istanbul, 34295, Turkey (Türkiye)
Yeditepe University Hospital
Istanbul, 34755, Turkey (Türkiye)
Addenbrooke's Hospital - Cambridge University Hospitals NHS Foundation Trust
Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom
Sarah Cannon Research Institute
London, Greater London, W1G 6AD, United Kingdom
Royal Marsden Hospital (RMH) - Royal Marsden NHS Foundation Trust
Chelsea, London, SW3 6JJ, United Kingdom
Royal Marsden Hospital (Sutton) - Royal Marsden NHS Foundation Trus
Sutton, London, SM2 5PT, United Kingdom
Royal Stoke University Hospital - University Hospitals of North Midlands NHS Trust
Stoke-on-Trent, Staffordshire, ST4 6QG, United Kingdom
Nottingham University Hospitals NHS Trust - Nottingham City Hospital
Nottingham, NG5 1PB, United Kingdom
New Cross Hospital
Wolverhampton, WV100QP, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 8, 2025
First Posted
October 20, 2025
Study Start
November 30, 2025
Primary Completion (Estimated)
June 30, 2028
Study Completion (Estimated)
November 30, 2028
Last Updated
September 14, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will not share