NCT07218146RecruitingPhase 3
A Study of ZL-1310 Versus Investigator's Choice of Therapy in Participants With Relapsed Small Cell Lung Cancer (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
Source: ClinicalTrials.gov · Last updated 16 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 480 (estimated)
- First submitted
- 8 Oct 2025
- Start date
- 30 Nov 2025
- Primary completion date
- 30 Jun 2028
- Lead sponsor
- Zai Lab (Shanghai) Co., Ltd.
- Diseases
- Lung cancer
- NCT number
- NCT07218146
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 480
- From 30 Nov 2025 to the primary completion date, 30 Jun 2028
- 165 sites in 15 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Received more than one line of systemic therapy for Extensive-Stage SCLC.
- Received any prior ADC with topoisomerase 1 inhibitor payload
- 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.
- 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.
Other illness
- 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.
- Known infection or active infection defined in the protocol.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (165)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Uniklinikum Salzburg, Landeskrankenhaus, Universitatsklinik fur Innere Medizin III der PMU Department of Internal Medicine III Coordinator of this site? Confirm its status | Salzburg | Austria | Recruiting |
| Medizinische Universitaet Wien - Allgemeines Krankenhaus der Stadt Wien (AKH) Coordinator of this site? Confirm its status | Vienna | Austria | Recruiting |
| Universitair Ziekenhuis Antwerpen Coordinator of this site? Confirm its status | Edegem | Belgium | Recruiting |
| Algemeen Ziekenhuis Sint-Lucas Coordinator of this site? Confirm its status | Ghent | Belgium | Recruiting |
| AZ Maria Middelares - Campus AZ Maria Middelares Coordinator of this site? Confirm its status | Ghent | Belgium | Recruiting |
| Jessa Ziekenhuis Salvador Coordinator of this site? Confirm its status | Hasselt | Belgium | Recruiting |
| Universitair Ziekenhuis Brussel Coordinator of this site? Confirm its status | Jette | Belgium | Recruiting |
| AZ Groeninge Coordinator of this site? Confirm its status | Kortrijk | Belgium | Recruiting |
| Vivalia St Joseph Coordinator of this site? Confirm its status | Libramont | Belgium | Recruiting |
| Universite Catholique de Louvain Namur, Centre Hospitalier Universitaire Dinant Godinne Coordinator of this site? Confirm its status | Yvoir | Belgium | Recruiting |
| Beijing Cancer Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Cancer Hospital, Chinese Academy of Medical Sciences Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Jilin Cancer Hospital Coordinator of this site? Confirm its status | Changchun | China | Recruiting |
| Hunan Cancer Hospital Coordinator of this site? Confirm its status | Changsha | China | Recruiting |
| Sichuan Cancer Hospital Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
| Fujian Cancer Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Recruiting |
| Guangdong Provincial People's Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Zhejiang Cancer Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| Anhui Provincial Hospital Coordinator of this site? Confirm its status | Hefei | China | Recruiting |
| Harbin medical university cancer hospital Coordinator of this site? Confirm its status | Heilongjiang | China | Recruiting |
| Shandong Cancer Hospital Coordinator of this site? Confirm its status | Jinan | China | Recruiting |
| LinYi Cancer Hospital Coordinator of this site? Confirm its status | Linyi | China | Recruiting |
| Jiangxi Cancer Hospital Coordinator of this site? Confirm its status | Nanchang | China | Recruiting |
| Guangxi Medical University Affiliated Tumor Hospital Coordinator of this site? Confirm its status | Naning | China | Recruiting |
| Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
| Shanghai Pulmonary Hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Fourth Hospital of Hebei Medical University Coordinator of this site? Confirm its status | Shijiazhuang | China | Recruiting |
| Taizhou Hospital of Zhejiang Province Coordinator of this site? Confirm its status | Taizhou | China | Recruiting |
| Hubei Cancer Hospital Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
| The First Affiliated hospital of Xiamen University Coordinator of this site? Confirm its status | Xiamen | China | Recruiting |
| The First Affiliated Hospital of Xi'an Jiaotong University Coordinator of this site? Confirm its status | Xi’an | China | Recruiting |
| Henan Cancer Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Recruiting |
| The First Affiliated Hospital of Zhengzhou University Coordinator of this site? Confirm its status | Zhengzhou | China | Recruiting |
| Nemocnice Horovice Coordinator of this site? Confirm its status | Hořovice | Czechia | Recruiting |
| Nemocnice AGEL Ostrava-Vitkovice a. s. Coordinator of this site? Confirm its status | Vítkovice | Czechia | Recruiting |
| Evangelische Lungenklinik Berlin Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| Krankenhaus Koeln-Merheim Coordinator of this site? Confirm its status | Cologne | Germany | Recruiting |
| University Hospital Carl Gustav Carus Coordinator of this site? Confirm its status | Dresden | Germany | Recruiting |
| Klinikum der Johann Wolfgang Goethe-Universität Coordinator of this site? Confirm its status | Frankfurt am Main | Germany | Recruiting |
| Krankenhaus Martha-Maria Halle-Doelau gGmbH Coordinator of this site? Confirm its status | Halle | Germany | Recruiting |
| Studiengesellschaft Haemato-Onkologie Hamburg, Prof. Laack und Partner Coordinator of this site? Confirm its status | Hamburg | Germany | Recruiting |
| UOMI Cancer Center-Clinica Tres Torres Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Clinic de Barcelona (Hospital Clinic i Provincial) Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital General Universitario de Elche Coordinator of this site? Confirm its status | Elche | Spain | Recruiting |
| Institut Català D'Oncologia Girona Coordinator of this site? Confirm its status | Girona | Spain | Recruiting |
| Hospital Universitario De Jerez Coordinator of this site? Confirm its status | Jerez de la Frontera | Spain | Recruiting |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Clinica Universidad de Navarra Madrid Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Quironsalud Malaga Coordinator of this site? Confirm its status | Málaga | Spain | Recruiting |
| Universidad de Navarra - Clínica Universidad de Navarra (CUN) Coordinator of this site? Confirm its status | Pamplona | Spain | Recruiting |
| Hospital Universitari Sant Joan De Reus, S.A Coordinator of this site? Confirm its status | Reus | Spain | Recruiting |
| Hospital Universitario Virgen Macarena / Clinical Research Department Coordinator of this site? Confirm its status | Seville | Spain | Recruiting |
| Hospital Universitario Virgen del Rocio Coordinator of this site? Confirm its status | Seville | Spain | Recruiting |
| Fundación Instituto Valenciano de Oncología Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Institut Sainte-Catherine Coordinator of this site? Confirm its status | Avignon | France | Recruiting |
| Hospices Civils de Lyon - Hopital Louis Pradel Coordinator of this site? Confirm its status | Bron | France | Recruiting |
| Centre Hospitalier Intercommunal de Creteil (CHIC) - Centre de ressources et de competences pour la mucoviscidose (C.R.C.M.) Coordinator of this site? Confirm its status | Créteil | France | Recruiting |
| Centre Hospitalier Le Mans Coordinator of this site? Confirm its status | Le Mans | France | Recruiting |
| Centre Hospitalier Universitaire (CHU) De Limoges Hopital Dupuytren Coordinator of this site? Confirm its status | Limoges | France | Recruiting |
| Centre Leon-Berard (CLB) - Centre de Recherche en Cancerologie Lyon-Est Coordinator of this site? Confirm its status | Lyon | France | Recruiting |
| Centre de Recherche Clinique Hôpital de la Croix-Rousse Coordinator of this site? Confirm its status | Lyon | France | Recruiting |
| Centre Hospitalier Regional Universitaire (CHRU) Montpellier Arnaud de Villeneuve Coordinator of this site? Confirm its status | Montpellier | France | Recruiting |
| Centre Hospitalier Lyon-Sud, CHLS Coordinator of this site? Confirm its status | Pierre-Bénite | France | Recruiting |
| Centre Hospitalier de Cornouaille - Hopital Laennec Coordinator of this site? Confirm its status | Quimper | France | Recruiting |
| Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes Coordinator of this site? Confirm its status | Saint-Herblain | France | Recruiting |
| Hopital Foch Coordinator of this site? Confirm its status | Suresnes | France | Recruiting |
| Centre Hospitalier Intercommunal Toulon La Seyne Sur Mer (C.H.I.T.S) - Hospital Font-Pre Coordinator of this site? Confirm its status | Toulon | France | Recruiting |
| Clinique Teissier Coordinator of this site? Confirm its status | Valenciennes | France | Recruiting |
| Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Recruiting |
| Royal Marsden Hospital (RMH) - Royal Marsden NHS Foundation Trust Coordinator of this site? Confirm its status | Chelsea | United Kingdom | Recruiting |
| Sarah Cannon Research Institute Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Nottingham University Hospitals NHS Trust - Nottingham City Hospital Coordinator of this site? Confirm its status | Nottingham | United Kingdom | Recruiting |
| Royal Stoke University Hospital - University Hospitals of North Midlands NHS Trust Coordinator of this site? Confirm its status | Stoke-on-Trent | United Kingdom | Recruiting |
| Royal Marsden Hospital (Sutton) - Royal Marsden NHS Foundation Trus Coordinator of this site? Confirm its status | Sutton | United Kingdom | Recruiting |
| New Cross Hospital Coordinator of this site? Confirm its status | Wolverhampton | United Kingdom | Recruiting |
| Sotiria General Hospital of Athens Coordinator of this site? Confirm its status | Athens | Greece | Recruiting |
| University General Hospital of Patras Coordinator of this site? Confirm its status | Rio | Greece | Recruiting |
| Iatriko Diavalkaniko Thessalonikis Coordinator of this site? Confirm its status | Thessaloniki | Greece | Recruiting |
| NOSILEFTIKI A.E. - Saint Luke's Clinic Coordinator of this site? Confirm its status | Thessaloniki | Greece | Recruiting |
| European Interbalkan Medical Center Coordinator of this site? Confirm its status | Thessaloniki | Greece | Recruiting |
| Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I Coordinator of this site? Confirm its status | Ancona | Italy | Recruiting |
| FPO IRCCS Candiolo Coordinator of this site? Confirm its status | Candiolo | Italy | Recruiting |
| IRCCS Istituto Romagnolo per lo studio dei Tumori Dino Amadori (IRST) Coordinator of this site? Confirm its status | Meldola | Italy | Recruiting |
| AUSL Della Romagna - Ospedale S.Maria delle Croci Coordinator of this site? Confirm its status | Ravenna | Italy | Recruiting |
| Istituti Fisioterapici Ospitalieri (IFO) - Istituto Nazionale Tumori Regina Elena (IRE) UO Oncologia Ospedali Civili di Livorno Coordinator of this site? Confirm its status | Roma | Italy | Recruiting |
| Centro Ricerche Cliniche di Verona s.r.l. Coordinator of this site? Confirm its status | Verona | Italy | Recruiting |
| Asahikawa Medical University Hospital Coordinator of this site? Confirm its status | Asahikawa | Japan | Recruiting |
| Nippon Medical School Hospital Coordinator of this site? Confirm its status | Bunkyo-ku | Japan | Recruiting |
| Komagome Hospital Coordinator of this site? Confirm its status | Bunkyō-Ku | Japan | Recruiting |
| Kyushu University Hospital Coordinator of this site? Confirm its status | Fukuoka | Japan | Recruiting |
| Kyushu Medical Center Coordinator of this site? Confirm its status | Fukuoka | Japan | Recruiting |
| Kansai Medical University Hospital Coordinator of this site? Confirm its status | Hirakata | Japan | Recruiting |
| Hiroshima University Hospital Coordinator of this site? Confirm its status | Hiroshima | Japan | Recruiting |
| Izumi City General Hospital Coordinator of this site? Confirm its status | Izumi | Japan | Recruiting |
| Nara Medical University Hospital Coordinator of this site? Confirm its status | Kashihara | Japan | Recruiting |
| National Cancer Center Hospital East Coordinator of this site? Confirm its status | Kashiwa | Japan | Recruiting |
| Dokkyo Medical University Saitama Medical Center Coordinator of this site? Confirm its status | Koshigaya | Japan | Recruiting |
| The Cancer Institute Hospital of JFCR Coordinator of this site? Confirm its status | Koto-ku | Japan | Recruiting |
| Kurume University Hospital Coordinator of this site? Confirm its status | Kurume | Japan | Recruiting |
| Shinshu University Hospital Coordinator of this site? Confirm its status | Matsumoto | Japan | Recruiting |
| National Hospital Organization Nagasaki Medical Center Coordinator of this site? Confirm its status | Ōmura | Japan | Recruiting |
| Osaka International Cancer Institute Coordinator of this site? Confirm its status | Osaka | Japan | Recruiting |
| Kinki Chuo Chest Medical Center Coordinator of this site? Confirm its status | Sakai | Japan | Recruiting |
| KKR Sapporo Medical Center Coordinator of this site? Confirm its status | Sapporo | Japan | Recruiting |
| Sendai Kousei Hospital Coordinator of this site? Confirm its status | Sendai | Japan | Recruiting |
| Dokkyo Medical University Hospital Coordinator of this site? Confirm its status | Shimosuga | Japan | Recruiting |
| National Center for Global Health and Medicine Coordinator of this site? Confirm its status | Shinjuku-Ku | Japan | Recruiting |
| Shizuoka Cancer Center Coordinator of this site? Confirm its status | Shizuoka | Japan | Recruiting |
| Kanagawa Cancer Center Coordinator of this site? Confirm its status | Yokohama | Japan | Recruiting |
| Amphia Ziekenhuis Coordinator of this site? Confirm its status | Breda | Netherlands | Recruiting |
| Tergooi Ziekenhuizen Coordinator of this site? Confirm its status | Hilversum | Netherlands | Recruiting |
| Instytut MSF Sp. z o.o. Coordinator of this site? Confirm its status | Lodz | Poland | Recruiting |
| Pratia S.A. , Pratia Poznan Coordinator of this site? Confirm its status | Poznan | Poland | Recruiting |
| Med Polonia Sp z o.o. Coordinator of this site? Confirm its status | Poznan | Poland | Recruiting |
| Wojewodzki Szpital im Sw Ojca Pio w Przemyslu Coordinator of this site? Confirm its status | Przemyśl | Poland | Recruiting |
| Wojskowy Instytut Medyczny,Centralny Szpital Kliniczny Ministerstwa Obronty Narodowej Coordinator of this site? Confirm its status | Siedlce | Poland | Recruiting |
| Wojskowy Instytut Medyczny Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Cleveland Clinic - Akron General Medical Center Coordinator of this site? Confirm its status | Akron | United States | Recruiting |
| University of Colorado Coordinator of this site? Confirm its status | Aurora | United States | Recruiting |
| Texas Oncology - Central South Coordinator of this site? Confirm its status | Austin | United States | Recruiting |
| American Oncology Partners, PA - The Center for Cancer and Blood Disorders Coordinator of this site? Confirm its status | Bethesda | United States | Recruiting |
| Consultants in Medical Oncology and Hematology Coordinator of this site? Confirm its status | Broomall | United States | Recruiting |
| Clermont Oncology Center Coordinator of this site? Confirm its status | Clermont | United States | Recruiting |
| University Hospitals Cleveland Medical Center* Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
| Cleveland Clinic - Fairview Hospital Molly Pavilion Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
| Missouri Cancer Associates Coordinator of this site? Confirm its status | Columbia | United States | Recruiting |
| University of Texas Southwestern Medical Center/Clinical Research Department Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| Henry Ford Health Cancer Coordinator of this site? Confirm its status | Detroit | United States | Recruiting |
| Virginia Cancer Specialists Coordinator of this site? Confirm its status | Fairfax | United States | Recruiting |
| University of Iowa Coordinator of this site? Confirm its status | Iowa City | United States | Recruiting |
| University of California San Diego Coordinator of this site? Confirm its status | La Jolla | United States | Recruiting |
| Norton Cancer Institute Coordinator of this site? Confirm its status | Louisville | United States | Recruiting |
| Cleveland Clinic - Hillcrest Hospital Cancer Center Coordinator of this site? Confirm its status | Mayfield Heights | United States | Recruiting |
| Alliance Cancer Specialists Coordinator of this site? Confirm its status | Media | United States | Recruiting |
| SCRI OP (Oncology Partners) Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
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| University of Pittsburgh (UPMC) Hillman Cancer Center Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
| Allegheny General Hospital Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
| Cancer Centers of Bevard Coordinator of this site? Confirm its status | Rockledge | United States | Recruiting |
| UC Davis Comprehensive Cancer Center Coordinator of this site? Confirm its status | Sacramento | United States | Recruiting |
| Sarah Cannon Research Institute Coordinator of this site? Confirm its status | Sarasota | United States | Recruiting |
| Maryland Oncology Hematology Coordinator of this site? Confirm its status | Silver Spring | United States | Recruiting |
| Mercy South Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
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| Montefiore Medical Center Coordinator of this site? Confirm its status | The Bronx | United States | Recruiting |
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| Medical Park Seyhan Hospital Coordinator of this site? Confirm its status | Adana | Turkey (Türkiye) | Recruiting |
| Baskent University Adana Turgut Noyan Application and Research Center Kisla Health Campus Coordinator of this site? Confirm its status | Adana | Turkey (Türkiye) | Recruiting |
| Ankara Bilkent City Hospital Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Recruiting |
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| Sakarya University - Faculty of Medicine Coordinator of this site? Confirm its status | Sakarya | Turkey (Türkiye) | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.