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

Last updated: May 13, 2026
Sponsor: Zai Lab (Shanghai) Co., Ltd.
Overall Status: Active - Recruiting

Phase

3

Condition

Small Cell Lung Cancer

Treatment

ZL-1310 Dose Level 2

ZL-1310 Dose Level 1

ZL-1310

Clinical Study ID

NCT07218146
ZL-1310-003
  • Ages > 18
  • All Genders

Study 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

Inclusion

Inclusion Criteria:

  • Age >/= 18 years, or considered an adult by local regulations, at the time ofconsent

  • Signed informed consent

  • Histologically or cytologically confirmed SCLC. Received 1L platinum-based systemictherapy and had documented disease progression during or after the most recentsystemic 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 CNSmetastases 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 tumortissue sample at Screening

  • Participants must be willing and able to comply with protocol for the duration ofthe study

Exclusion

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 pulmonaryillnesses.

  • Receipt of anti-cancer treatment known to treat cancers within 3 weeks before thefirst 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 foralopecia and skin pigmentation.

  • Known infection or active infection defined in the protocol.

  • Clinically significant active cardiovascular disease or history of arterialthromboembolic event within 6 months prior to the first dose of study treatmentbased on criteria per protocol.

Study Design

Total Participants: 480
Treatment Group(s): 4
Primary Treatment: ZL-1310 Dose Level 2
Phase: 3
Study Start date:
November 30, 2025
Estimated Completion Date:
November 30, 2028

Connect with a study center

  • Zai Lab Site 01002

    Hefei, Anhui 230036
    China

    Active - Recruiting

  • Zai Lab Site 01014

    Xiamen, Fujian 361000
    China

    Active - Recruiting

  • Zai Lab Site 01001

    Guangzhou, Guangdong 510080
    China

    Active - Recruiting

  • Zai Lab Site 01011

    Naning, Guangxi 530021
    China

    Active - Recruiting

  • Zai Lab Site 01008

    Shijiazhuang, Hebei
    China

    Active - Recruiting

  • Zai Lab Site 01010

    Zhengzhou, Henan 450052
    China

    Active - Recruiting

  • Zai Lab Site 01034

    Wuhan, Hubei 430079
    China

    Active - Recruiting

  • Zai Lab Site 01012

    Nanjing, Jiangsu
    China

    Active - Recruiting

  • Zai Lab Site 01015

    Nanchang, Jiangxi 330029
    China

    Active - Recruiting

  • Zai Lab Site 01009

    Xi'an, Shaanxi 710061
    China

    Active - Recruiting

  • Zai Lab Site 01007

    Jinan, Shandong 250117
    China

    Active - Recruiting

  • Zai Lab Site 01005

    Linyi, Shandong 276000
    China

    Active - Recruiting

  • Zai Lab Site 01043

    Shanghai, Shanghai Municipality 200433
    China

    Active - Recruiting

  • Zai Lab SIte 01026

    Chengdu, Sichuan 610041
    China

    Active - Recruiting

  • Zai Lab Site 01017

    Hangzhou, Zhejiang 310000
    China

    Active - Recruiting

  • Zai Lab Site 01016

    Taizhou, Zhejiang 318000
    China

    Active - Recruiting

  • Zai Lab Site 10019

    Kurume, Fukuoka 830-0011
    Japan

    Active - Recruiting

  • Zai Lab Site 10015

    Kashihara, Nara 634-8522
    Japan

    Active - Recruiting

  • Zai Lab Site 10014

    Izumi, Osaka 594-0073
    Japan

    Active - Recruiting

  • Zai Lab Site 10010

    Shizuoka, Sunto-gun 411-8777
    Japan

    Active - Recruiting

  • Zai Lab Site 10003

    Shimosuga, Tochigi 321-0293
    Japan

    Active - Recruiting

  • Zai Lab Site 10006

    Bunkyō-Ku, Tokyo 113-8677
    Japan

    Active - Recruiting

  • Zai Lab Site 10008

    Bunkyō-Ku, Tokyo 113-8603
    Japan

    Active - Recruiting

  • Zai Lab Site 10005

    Koto-Ku, Tokyo 135-8550
    Japan

    Active - Recruiting

  • Zai Lab Site 10007

    Shinjuku-Ku, Tokyo 162-8655
    Japan

    Active - Recruiting

  • Zai Lab Site 10017

    Fukuoka, 812-8582
    Japan

    Active - Recruiting

  • Zai Lab Site 10018

    Fukuoka, 810-8563
    Japan

    Active - Recruiting

  • Zai Lab Site 10013

    Osaka, 541-8567
    Japan

    Active - Recruiting

  • Zai Lab Site 02037

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • Zai Lab Site 02030

    New Haven, Connecticut 06519
    United States

    Active - Recruiting

  • Zai Lab Site 02045

    Clermont, Florida 34711
    United States

    Active - Recruiting

  • Zai Lab Site 02031

    Orange City, Florida 32763
    United States

    Active - Recruiting

  • Zai Lab Site 02020

    Rockledge, Florida 32955
    United States

    Active - Recruiting

  • Zai Lab Site 02026

    Sarasota, Florida 34232
    United States

    Active - Recruiting

  • Zai Lab Site 02052

    St. Petersburg, Florida 33701-4553
    United States

    Active - Recruiting

  • Zai Lab Site 02051

    West Palm Beach, Florida 33401
    United States

    Active - Recruiting

  • Zai Lab Site 02045

    Clermont 4151352, Florida 4155751 34711
    United States

    Site Not Available

  • Zai Lab Site 02031

    Orange City 4167055, Florida 4155751 32763
    United States

    Site Not Available

  • Zai Lab Site 02026

    Sarasota 4172131, Florida 4155751 34232
    United States

    Site Not Available

  • Zai Lab Site 02021

    Peoria, Illinois 61615
    United States

    Active - Recruiting

  • Zai Lab Site 02049

    Peoria, Illinois 61637
    United States

    Active - Recruiting

  • Zai Lab Site 02019

    Peoria 4905687, Illinois 4896861 61615
    United States

    Site Not Available

  • Zai Lab Site 02049

    Peoria 4905687, Illinois 4896861 61637
    United States

    Active - Recruiting

  • Zai Lab Site 02038

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

  • Zai Lab Site 02041

    Louisville, Kentucky 40202
    United States

    Active - Recruiting

  • Zai Lab Site 02041

    Louisville 4299276, Kentucky 6254925 40202
    United States

    Site Not Available

  • Zai Lab Site 02003

    Bethesda, Maryland 20817
    United States

    Active - Recruiting

  • Zai Lab Site 02022

    Silver Spring, Maryland 20904
    United States

    Active - Recruiting

  • Zai Lab Site 02003

    Bethesda 4348599, Maryland 4361885 20817
    United States

    Site Not Available

  • Zai Lab Site 02010

    Detroit, Michigan 48202
    United States

    Active - Recruiting

  • Zai Lab Site 02023

    Columbia, Missouri 65201
    United States

    Active - Recruiting

  • Zai Lab Site 02009

    St Louis, Missouri 63128
    United States

    Active - Recruiting

  • Zai Lab Site 02023

    Columbia 4381982, Missouri 4398678 65201
    United States

    Site Not Available

  • Zai Lab Site 02040

    The Bronx, New York 10461
    United States

    Active - Recruiting

  • Zai Lab Site 02024

    Cleveland, Ohio 44106
    United States

    Active - Recruiting

  • Zai Lab Site 02035

    Broomall, Pennsylvania 19008
    United States

    Active - Recruiting

  • Zai Lab Site 02019

    Media, Pennsylvania 19063
    United States

    Active - Recruiting

  • Zai Lab Site 02008

    Pittsburgh, Pennsylvania 15212
    United States

    Active - Recruiting

  • Zai Lab Site 02029

    Pittsburgh, Pennsylvania 15232
    United States

    Active - Recruiting

  • Zai Lab Site 02019

    Media 4559575, Pennsylvania 6254927 19063
    United States

    Site Not Available

  • Zai Lab Site 02036

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Zai Lab Site 02025

    Austin, Texas 78745
    United States

    Active - Recruiting

  • Zai Lab Site 02046

    Dallas, Texas 75390-9020
    United States

    Active - Recruiting

  • Zai Lab Site 02025

    Odessa, Texas 79761
    United States

    Active - Recruiting

  • Zai Lab Site 02006

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.