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

Small Cell Lung Cancer

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, Lurbinectedin, or Amrubicin

Locations(34)

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 02021

Peoria, Illinois, United States

Zai Lab Site 02049

Peoria, Illinois, 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 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 02025

Odessa, Texas, United States

Zai Lab Site 02006

Fairfax, Virginia, United States

Zai Lab Site 01001

Guangzhou, Guangdong, China

Zai Lab Site 01011

Naning, Guangxi, China

Zai Lab Site 01010

Zhengzhou, Henan, China

Zai Lab Site 01034

Wuhan, Hubei, China

Zai Lab Site 01015

Nanchang, Jiangxi, China

Zai Lab Site 01007

Jinan, Shandong, China

Zai Lab Site 01005

Linyi, Shandong, China

Zai Lab SIte 01026

Chengdu, Sichuan, China

Zai Lab Site 01017

Hangzhou, Zhejiang, China

Zai Lab Site 10003

Shimosuga, Tochigi, Japan

Zai Lab Site 10017

Fukuoka, Japan

Zai Lab Site 10013

Osaka, Japan

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