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RECRUITING
NCT07218146
PHASE3

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

Sponsor: Zai Lab (Shanghai) Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

480

Start Date

2025-11-30

Completion Date

2028-11-30

Last Updated

2026-05-14

Healthy Volunteers

No

Interventions

DRUG

ZL-1310

ZL-1310 as a single-agent

DRUG

Investigator's Choice of Therapy

Topotecan, Lurbinectedin, or Amrubicin

Locations (56)

Zai Lab Site 02037

Aurora, Colorado, United States

Zai Lab Site 02030

New Haven, Connecticut, United States

Zai Lab Site 02045

Clermont, Florida, United States

Zai Lab Site 02031

Orange City, Florida, United States

Zai Lab Site 02020

Rockledge, Florida, United States

Zai Lab Site 02026

Sarasota, Florida, United States

Zai Lab Site 02052

St. Petersburg, Florida, United States

Zai Lab Site 02051

West Palm Beach, Florida, United States

Zai Lab Site 02021

Peoria, Illinois, United States

Zai Lab Site 02049

Peoria, Illinois, United States

Zai Lab Site 02038

Iowa City, Iowa, United States

Zai Lab Site 02041

Louisville, Kentucky, United States

Zai Lab Site 02003

Bethesda, Maryland, United States

Zai Lab Site 02022

Silver Spring, Maryland, United States

Zai Lab Site 02010

Detroit, Michigan, United States

Zai Lab Site 02023

Columbia, Missouri, United States

Zai Lab Site 02009

St Louis, Missouri, United States

Zai Lab Site 02040

The Bronx, New York, United States

Zai Lab Site 02024

Cleveland, Ohio, United States

Zai Lab Site 02035

Broomall, Pennsylvania, United States

Zai Lab Site 02019

Media, Pennsylvania, United States

Zai Lab Site 02008

Pittsburgh, Pennsylvania, United States

Zai Lab Site 02029

Pittsburgh, Pennsylvania, United States

Zai Lab Site 02036

Nashville, Tennessee, United States

Zai Lab Site 02025

Austin, Texas, United States

Zai Lab Site 02046

Dallas, Texas, United States

Zai Lab Site 02025

Odessa, Texas, United States

Zai Lab Site 02006

Fairfax, Virginia, United States

Zai Lab Site 01002

Hefei, Anhui, China

Zai Lab Site 01014

Xiamen, Fujian, China

Zai Lab Site 01001

Guangzhou, Guangdong, China

Zai Lab Site 01011

Naning, Guangxi, China

Zai Lab Site 01008

Shijiazhuang, Hebei, China

Zai Lab Site 01010

Zhengzhou, Henan, China

Zai Lab Site 01034

Wuhan, Hubei, China

Zai Lab Site 01012

Nanjing, Jiangsu, China

Zai Lab Site 01015

Nanchang, Jiangxi, China

Zai Lab Site 01009

Xi'an, Shaanxi, China

Zai Lab Site 01007

Jinan, Shandong, China

Zai Lab Site 01005

Linyi, Shandong, China

Zai Lab Site 01043

Shanghai, Shanghai Municipality, China

Zai Lab SIte 01026

Chengdu, Sichuan, China

Zai Lab Site 01017

Hangzhou, Zhejiang, China

Zai Lab Site 01016

Taizhou, Zhejiang, China

Zai Lab Site 10019

Kurume, Fukuoka, Japan

Zai Lab Site 10015

Kashihara, Nara, Japan

Zai Lab Site 10014

Izumi, Osaka, Japan

Zai Lab Site 10010

Shizuoka, Sunto-gun, Japan

Zai Lab Site 10003

Shimosuga, Tochigi, Japan

Zai Lab Site 10008

Bunkyō-Ku, Tokyo, Japan

Zai Lab Site 10006

Bunkyō-Ku, Tokyo, Japan

Zai Lab Site 10005

Koto-Ku, Tokyo, Japan

Zai Lab Site 10007

Shinjuku-Ku, Tokyo, Japan

Zai Lab Site 10018

Fukuoka, Japan

Zai Lab Site 10017

Fukuoka, Japan

Zai Lab Site 10013

Osaka, Japan