RecruitingPhase 3NCT07218146

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


Sponsor

Zai Lab (Shanghai) Co., Ltd.

Enrollment

480 participants

Start Date

Nov 30, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (called DLLEVATE) is comparing a new drug called ZL-1310 against the doctor's choice of treatment for people with small cell lung cancer (SCLC) that has come back after initial treatment. Small cell lung cancer is a fast-growing form of lung cancer that often returns after first-line therapy. **You may be eligible if...** - You are 18 or older and have been confirmed to have small cell lung cancer - Your cancer has come back or worsened after receiving first-line platinum-based chemotherapy, or after second-line tarlatamab treatment - Your cancer can be measured on a scan - You are generally healthy enough to undergo treatment (ECOG performance status 0 or 1) - Your life expectancy is at least 3 months - You are willing to provide a tumor biopsy or archived tissue sample **You may NOT be eligible if...** - You have received more than one prior line of chemotherapy for extensive-stage SCLC - You have previously received certain antibody-drug conjugates (ADCs) with a topoisomerase 1 inhibitor - You have a history of certain lung inflammation (ILD/pneumonitis) - You have another active cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGZL-1310

ZL-1310 as a single-agent

DRUGInvestigator's Choice of Therapy

Topotecan or Amrubicin


Locations(155)

University of California San Diego

La Jolla, California, United States

UC Davis Comprehensive Cancer Center

Sacramento, California, United States

University of Colorado

Aurora, Colorado, United States

Yale Cancer Center/Clinical Trials Office

New Haven, Connecticut, United States

Clermont Oncology Center

Clermont, Florida, United States

Mid Florida Hematology and Oncology Center

Orange City, Florida, United States

Cancer Centers of Bevard

Rockledge, Florida, United States

Sarah Cannon Research Institute

Sarasota, Florida, United States

Florida Cancer Specialists - North

St. Petersburg, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

Florida Cancer Specialists - East

West Palm Beach, Florida, United States

Illinois Cancer Care

Peoria, Illinois, United States

OSF St. Francis Medical Center

Peoria, Illinois, United States

University of Iowa

Iowa City, Iowa, United States

University of Iowa Mission Health Cancer + Blood

Waukee, Iowa, United States

Norton Cancer Institute

Louisville, Kentucky, United States

American Oncology Partners, PA - The Center for Cancer and Blood Disorders

Bethesda, Maryland, United States

Maryland Oncology Hematology

Silver Spring, Maryland, United States

Henry Ford Health Cancer

Detroit, Michigan, United States

Missouri Cancer Associates

Columbia, Missouri, United States

Mercy South

St Louis, Missouri, United States

Stony Brook Cancer Center

Stony Brook, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Cleveland Clinic - Akron General Medical Center

Akron, Ohio, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Cleveland Clinic - Fairview Hospital Molly Pavilion

Cleveland, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

Cleveland Clinic - Hillcrest Hospital Cancer Center

Mayfield Heights, Ohio, United States

Consultants in Medical Oncology and Hematology

Broomall, Pennsylvania, United States

Alliance Cancer Specialists

Media, Pennsylvania, United States

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

University of Pittsburgh (UPMC) Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

SCRI OP (Oncology Partners)

Nashville, Tennessee, United States

Texas Oncology - Central South

Austin, Texas, United States

University of Texas Southwestern Medical Center/Clinical Research Department

Dallas, Texas, United States

Texas Oncology - West Texas

Odessa, Texas, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

Uniklinikum Salzburg, Landeskrankenhaus, Universitatsklinik fur Innere Medizin III der PMU Department of Internal Medicine III

Salzburg, Austria

Universitair Ziekenhuis Antwerpen

Edegem, Belgium

Algemeen Ziekenhuis Sint-Lucas

Ghent, Belgium

AZ Maria Middelares - Campus AZ Maria Middelares

Ghent, Belgium

Jessa Ziekenhuis Salvador

Hasselt, Belgium

Universitair Ziekenhuis Brussel

Jette, Belgium

AZ Groeninge

Kortrijk, Belgium

Vivalia St Joseph

Libramont, Belgium

Universite Catholique de Louvain Namur, Centre Hospitalier Universitaire Dinant Godinne

Yvoir, Belgium

Anhui Provincial Hospital

Hefei, Anhui, China

Fujian Cancer Hospital

Fuzhou, Fujian, China

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Guangxi Medical University Affiliated Tumor Hospital

Naning, Guangxi, China

Harbin Medical University Cancer Hospital

Heilongjiang, Harbin, China

Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Hubei Cancer Hospital

Wuhan, Hubei, China

Hunan Cancer Hospital

Changsha, Hunan, China

Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

Jiangxi Cancer Hospital

Nanchang, Jiangxi, China

Jilin Cancer Hospital

Changchun, Jilin, China

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Shandong Cancer Hospital

Jinan, Shandong, China

Linyi Cancer Hospital

Linyi, Shandong, China

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

Sichuan Cancer Hospital

Chengdu, Sichuan, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Taizhou Hospital of Zhejiang Province

Taizhou, Zhejiang, China

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, China

Beijing Cancer Hospital

Beijing, China

Henan cancer Hospital

Zhengzhou, China

Nemocnice Horovice

Hořovice, Czechia

Nemocnice AGEL Ostrava-Vitkovice a. s.

Vítkovice, Czechia

Institut Sainte Catherine

Avignon, France

Hospices Civils de Lyon - Hopital Louis Pradel

Bron, France

Centre Hospitalier Intercommunal de Creteil (CHIC) - Centre de ressources et de competences pour la mucoviscidose (C.R.C.M.)

Créteil, France

Centre Hospitalier - Le Mans

Le Mans, France

Centre Hospitalier Universitaire (CHU) De Limoges Hopital Dupuytren

Limoges, France

Centre de Recherche Clinique Hôpital de la Croix-Rousse

Lyon, France

Centre Hospitalier Regional Universitaire (CHRU) Montpellier Arnaud de Villeneuve

Montpellier, France

Centre Hospitalier Lyon-Sud, CHLS

Pierre-Bénite, France

Centre Hospitalier de Cornouaille - Hopital Laennec

Quimper, France

Hopital Foch

Suresnes, France

Centre Hospitalier Intercommunal Toulon La Seyne Sur Mer (C.H.I.T.S) - Hospital Font-Pre

Toulon, France

Clinique Teissier

Valenciennes, France

Klinikum der Johann Wolfgang Goethe-Universität

Frankfurt am Main, Hesse, Germany

Evangelische Lungenklinik Berlin

Berlin, Germany

University Hospital Carl Gustav Carus

Dresden, Germany

Krankenhaus Martha-Maria Halle-Doelau gGmbH

Halle, Germany

Iatriko Diavalkaniko Thessalonikis

Thessaloniki, Greece

Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I

Ancona, Italy

FPO IRCCS Candiolo

Candiolo, Italy

IRCCS Istituto Romagnolo per lo studio dei Tumori "Dino Amadori"(IRST)

Meldola, Italy

AUSL Della Romagna - Ospedale S.Maria delle Croci

Ravenna, Italy

Istituti Fisioterapici Ospitalieri (IFO) - Istituto Nazionale Tumori Regina Elena (IRE) UO Oncologia Ospedali Civili di Livorno

Roma, Italy

Centro Ricerche Cliniche di Verona s.r.l.

Verona, Italy

Kyushu Medical Center

Fukuoka, Fukuoka, Japan

Kyushu University Hospital

Fukuoka, Fukuoka, Japan

Kurume University Hospital

Kurume, Fukuoka, Japan

Hiroshima University Hospital

Hiroshima, Hiroshima, Japan

Asahikawa Medical University Hospital

Asahikawa, Hokkaido, Japan

KKR Sapporo Medical Center

Sapporo, Hokkaido, Japan

Kanagawa Cancer Center

Yokohama, Kanagawa, Japan

Sendai Kousei Hospital

Sendai, Miyagi, Japan

Shinshu University Hospital

Matsumoto, Nagano, Japan

National Hospital Organization Nagasaki Medical Center

Ōmura, Nagasaki, Japan

Nara Medical University Hospital

Kashihara, Nara, Japan

Kansai Medical University Hospital

Hirakata, Osaka, Japan

Izumi City General Hospital

Izumi, Osaka, Japan

Osaka International Cancer Institute

Osaka, Osaka, Japan

Kinki Chuo Chest Medical Center

Sakai, Osaka, Japan

Dokkyo Medical University Saitama Medical Center

Koshigaya, Saitama, Japan

Shizuoka Cancer Center

Shizuoka, Sunto-gun, Japan

Dokkyo Medical University Hospital

Shimosuga, Tochigi, Japan

Nippon Medical School Hospital

Bunkyō-Ku, Tokyo, Japan

Komagome Hospital

Bunkyō-Ku, Tokyo, Japan

The Cancer Institute Hospital of JFCR

Koto-Ku, Tokyo, Japan

National Center for Global Health and Medicine

Shinjuku-Ku, Tokyo, Japan

Amphia Ziekenhuis

Breda, Netherlands

Tergooi Ziekenhuizen

Hilversum, Netherlands

Instytut MSF Sp. z o.o.

Lodz, Poland

Pratia S.A. , Pratia Poznan

Poznan, Poland

Med-Polonia Sp. z o.o.

Poznan, Poland

Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu

Przemyśl, Poland

Wojskowy Instytut Medyczny,Centralny Szpital Kliniczny Ministerstwa Obronty Narodowej

Siedlce, Poland

Wojskowy Instytut Medyczny

Warsaw, Poland

Fundación Instituto Valenciano de Oncología

Valencia, Valencia, Spain

UOMI Cancer Center-Clinica Tres Torres

Barcelona, Spain

Hospital Clinic de Barcelona (Hospital Clinic i Provincial)

Barcelona, Spain

Hospital General Universitario de Elche

Elche, Spain

Institut Catala d'Oncologia GIRONA

Girona, Spain

Hospital Universitario de Jerez

Jerez de la Frontera, Spain

Hospital Universitario Ramon y Cajal

Madrid, Spain

Hospital Universitario La Paz

Madrid, Spain

Clinica Universidad de Navarra - Madrid

Madrid, Spain

Hospital Quironsalud Malaga

Málaga, Spain

Universidad de Navarra - Clínica Universidad de Navarra (CUN)

Pamplona, Spain

Hospital Universitari Sant Joan De Reus, S.A

Reus, Spain

Hospital Universitario Virgen Macarena / Clinical Research Department

Seville, Spain

Hospital Universitario Virgen del Rocio

Seville, Spain

Baskent University Adana Turgut Noyan Application and Research Center Kisla Health Campus

Adana, Adana, Turkey (Türkiye)

Ankara Bilkent City Hospital

Ankara, Ankara, Turkey (Türkiye)

Memorial Ankara Hospital

Çankaya, Ankara, Turkey (Türkiye)

Istanbul University Cerrahpasa Faculty of Medicine Hospital

Fatih, Istanbul, Turkey (Türkiye)

Istanbul Medeniyet University Medical Faculty

Kadıköy, Istanbul, Turkey (Türkiye)

Sakarya University - Faculty of Medicine

Adapazarı, Sakarya, Turkey (Türkiye)

Medical Park Seyhan Hospital

Adana, Turkey (Türkiye)

Liv Hospital Ankara

Ankara, Turkey (Türkiye)

Medical Park Florya Hospital

Istanbul, Turkey (Türkiye)

Yeditepe University Hospital

Istanbul, Turkey (Türkiye)

Addenbrooke's Hospital - Cambridge University Hospitals NHS Foundation Trust

Cambridge, Cambridgeshire, United Kingdom

Sarah Cannon Research Institute

London, Greater London, United Kingdom

Royal Marsden Hospital (RMH) - Royal Marsden NHS Foundation Trust

Chelsea, London, United Kingdom

Royal Marsden Hospital (Sutton) - Royal Marsden NHS Foundation Trus

Sutton, London, United Kingdom

Royal Stoke University Hospital - University Hospitals of North Midlands NHS Trust

Stoke-on-Trent, Staffordshire, United Kingdom

Nottingham University Hospitals NHS Trust - Nottingham City Hospital

Nottingham, United Kingdom

New Cross Hospital

Wolverhampton, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT07218146


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