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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

Zai Lab Site 02050

La Jolla, California 92093

United States

Zai Lab Site 02033

Sacramento, California 95817

United States

Zai Lab Site 02037

Aurora, Colorado 80045

United States

Zai Lab Site 02030

New Haven, Connecticut 06519

United States

Zai Lab Site 02045

Clermont, Florida 34711

United States

Zai Lab Site 02031

Orange City, Florida 32763

United States

Zai Lab Site 02020

Rockledge, Florida 32955

United States

Zai Lab Site 02026

Sarasota, Florida 34232

United States

Zai Lab Site 02052

St. Petersburg, Florida 33701-4553

United States

Zai Lab Site 02047

Tampa, Florida 33612

United States

Zai Lab Site 02051

West Palm Beach, Florida 33401

United States

Zai Lab Site 02021

Peoria, Illinois 61615

United States

Zai Lab Site 02049

Peoria, Illinois 61637

United States

Zai Lab Site 02038

Iowa City, Iowa 52242

United States

Zai Lab Site 02041

Louisville, Kentucky 40202

United States

Zai Lab Site 02003

Bethesda, Maryland 20817

United States

Zai Lab Site 02022

Silver Spring, Maryland 20904

United States

Zai Lab Site 02010

Detroit, Michigan 48202

United States

Zai Lab Site 02023

Columbia, Missouri 65201

United States

Zai Lab Site 02009

St Louis, Missouri 63128

United States

Zai Lab Site 02040

The Bronx, New York 10461

United States

Zai Lab Site 02024

Cleveland, Ohio 44106

United States

Zai Lab Site 02035

Broomall, Pennsylvania 19008

United States

Zai Lab Site 02019

Media, Pennsylvania 19063

United States

Zai Lab Site 02008

Pittsburgh, Pennsylvania 15212

United States

Zai Lab Site 02029

Pittsburgh, Pennsylvania 15232

United States

Zai Lab Site 02036

Nashville, Tennessee 37203

United States

Zai Lab Site 02025

Austin, Texas 78745

United States

Zai Lab Site 02046

Dallas, Texas 75390-9020

United States

Zai Lab Site 02025

Odessa, Texas 79761

United States

Zai Lab Site 02006

Fairfax, Virginia 22031

United States

Zai Lab Site 01002

Hefei, Anhui 230036

China

Zai Lab Site 01014

Xiamen, Fujian 361000

China

Zai Lab Site 01001

Guangzhou, Guangdong 510080

China

Zai Lab Site 01011

Naning, Guangxi 530021

China

Zai Lab Site 01022

Heilongjiang, Harbin 000000

China

Zai Lab Site 01008

Shijiazhuang, Hebei

China

Zai Lab Site 01010

Zhengzhou, Henan 450052

China

Zai Lab Site 01034

Wuhan, Hubei 430079

China

Zai Lab Site 01012

Nanjing, Jiangsu

China

Zai Lab Site 01015

Nanchang, Jiangxi 330029

China

Zai Lab Site 01009

Xi'an, Shaanxi 710061

China

Zai Lab Site 01007

Jinan, Shandong 250117

China

Zai Lab Site 01005

Linyi, Shandong 276000

China

Zai Lab Site 01043

Shanghai, Shanghai Municipality 200433

China

Zai Lab SIte 01026

Chengdu, Sichuan 610041

China

Zai Lab Site 01017

Hangzhou, Zhejiang 310000

China

Zai Lab Site 01016

Taizhou, Zhejiang 318000

China

Zai Lab Site 01004

Beijing, 100142

China

Zai Lab Site 10019

Kurume, Fukuoka 830-0011

Japan

Zai Lab Site 10009

Yokohama, Kanagawa 241-8515

Japan

Zai Lab Site 10015

Kashihara, Nara 634-8522

Japan

Zai Lab Site 10011

Hirakata, Osaka 573-1191

Japan

Zai Lab Site 10014

Izumi, Osaka 594-0073

Japan

Zai Lab Site 10012

Sakai, Osaka 591-8555

Japan

Zai Lab Site 10010

Shizuoka, Sunto-gun 411-8777

Japan

Zai Lab Site 10003

Shimosuga, Tochigi 321-0293

Japan

Zai Lab Site 10008

Bunkyō-Ku, Tokyo 113-8603

Japan

Zai Lab Site 10006

Bunkyō-Ku, Tokyo 113-8677

Japan

Zai Lab Site 10005

Koto-Ku, Tokyo 135-8550

Japan

Zai Lab Site 10007

Shinjuku-Ku, Tokyo 162-8655

Japan

Zai Lab Site 10018

Fukuoka, 810-8563

Japan

Zai Lab Site 10017

Fukuoka, 812-8582

Japan

Zai Lab Site 10016

Hiroshima, 734-8551

Japan

Zai Lab Site 10013

Osaka, 541-8567

Japan

Zai Lab Site 21003

London, Greater London W1G 6AD

United Kingdom