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NCT07218146PHASE3Recruiting

A Study of ZL-1310 Versus Investigator's Choice of Therapy in Participants With Relapsed Small Cell Lung Cancer (DLLEVATE)

Zai Lab (Shanghai) Co., Ltd.

Start Date

11/30/2025

Completion Date

11/30/2028

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 Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * 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 Exclusion Criteria: * 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.

Interventions

DRUG

ZL-1310

DRUG

Investigator's Choice of Therapy

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Conditions

Small-cell Lung Cancer

Locations

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