Recruiting
Phase 3

ZL-1310 vs. Investigator's Choice

Sponsor:

Zai Lab (Shanghai) Co., Ltd.

Code:

NCT07218146

Conditions

Small-cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ZL-1310

Investigator's Choice of Therapy

Study Details

Brief 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.

Conditions

Small-cell Lung Cancer

Study ID

NCT07218146

Start date

Nov 30, 2025

Status verified date

Aug, 2026

Completion date

Nov 30, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

480 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm 1

ZL-1310 as a single agent

active comparator: Arm 2

Investigator's Choice of Therapy

Interventions

ZL-1310

ZL-1310 as a single-agent

Investigator's Choice of Therapy

Topotecan or Amrubicin

Primary outcome measure

  • Confirmed objective response rate (ORR) assessed by Blinded Independent Central Review of ZL-1310 compared to Investigator's Choice Therapy (ICT) [ Time Frame: up to 30 months ]
  • Overall survival of ZL-1310 compared to Investigator's Choice Therapy (ICT) [ Time Frame: up to 30 months ]

Central Contacts and Locations

Central contacts

ZL-1310-003 Study Team

650-360-1601study-ZL-1310-003@zailaboratory.com

Locations

University of California San Diego

Recruiting

La Jolla, California, United States, 92093

UC Davis Comprehensive Cancer Center

Recruiting

Sacramento, California, United States, 95817

University of Colorado

Recruiting

Aurora, Colorado, United States, 80045

Yale Cancer Center/Clinical Trials Office

Recruiting

New Haven, Connecticut, United States, 06519

Clermont Oncology Center

Recruiting

Clermont, Florida, United States, 34711

Mid Florida Hematology and Oncology Center

Recruiting

Orange City, Florida, United States, 32763

Cancer Centers of Bevard

Recruiting

Rockledge, Florida, United States, 32955

Sarah Cannon Research Institute

Recruiting

Sarasota, Florida, United States, 34232

Florida Cancer Specialists - North

Recruiting

St. Petersburg, Florida, United States, 33701-4553

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Florida Cancer Specialists - East

Recruiting

West Palm Beach, Florida, United States, 33401

Illinois Cancer Care

Recruiting

Peoria, Illinois, United States, 61615

OSF St. Francis Medical Center

Recruiting

Peoria, Illinois, United States, 61637

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

University of Iowa Mission Health Cancer + Blood

Recruiting

Waukee, Iowa, United States, 50263

Norton Cancer Institute

Recruiting

Louisville, Kentucky, United States, 40202

American Oncology Partners, PA - The Center for Cancer and Blood Disorders

Recruiting

Bethesda, Maryland, United States, 20817

Maryland Oncology Hematology

Recruiting

Silver Spring, Maryland, United States, 20904

Henry Ford Health Cancer

Recruiting

Detroit, Michigan, United States, 48202

Missouri Cancer Associates

Recruiting

Columbia, Missouri, United States, 65201

Mercy South

Recruiting

St Louis, Missouri, United States, 63128

Stony Brook Cancer Center

Recruiting

Stony Brook, New York, United States, 11794-7007

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10461

Cleveland Clinic - Akron General Medical Center

Recruiting

Akron, Ohio, United States, 44302

University Hospitals Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Cleveland Clinic - Fairview Hospital Molly Pavilion

Recruiting

Cleveland, Ohio, United States, 44111

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Cleveland Clinic - Hillcrest Hospital Cancer Center

Recruiting

Mayfield Heights, Ohio, United States, 44124

Consultants in Medical Oncology and Hematology

Recruiting

Broomall, Pennsylvania, United States, 19008

Alliance Cancer Specialists

Recruiting

Media, Pennsylvania, United States, 19063

Allegheny General Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15212

University of Pittsburgh (UPMC) Hillman Cancer Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

SCRI OP (Oncology Partners)

Recruiting

Nashville, Tennessee, United States, 37203

Texas Oncology - Central South

Recruiting

Austin, Texas, United States, 78745

University of Texas Southwestern Medical Center/Clinical Research Department

Recruiting

Dallas, Texas, United States, 75390-9020

Texas Oncology - West Texas

Recruiting

Odessa, Texas, United States, 79761

Virginia Cancer Specialists

Recruiting

Fairfax, Virginia, United States, 22031

More Information

Sponsor

Zai Lab (Shanghai) Co., Ltd.

Last update posted

Sep 4, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Zai Lab (Shanghai) Co., Ltd. on 2026-09-04.