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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm 1 		ZL-1310 as a single agent
  • Drug: ZL-1310
    ZL-1310 as a single-agent
Active Comparator
Arm 2 		Investigator's Choice of Therapy
  • Drug: Investigator's Choice of Therapy
    Topotecan or Amrubicin

Recruiting Locations

University of California San Diego
La Jolla, California 92093

UC Davis Comprehensive Cancer Center
Sacramento, California 95817

University of Colorado
Aurora, Colorado 80045

Yale Cancer Center/Clinical Trials Office
New Haven, Connecticut 06519

Clermont Oncology Center
Clermont, Florida 34711

Mid Florida Hematology and Oncology Center
Orange City, Florida 32763

Cancer Centers of Bevard
Rockledge, Florida 32955

Sarah Cannon Research Institute
Sarasota, Florida 34232

Florida Cancer Specialists - North
St. Petersburg, Florida 33701-4553

Moffitt Cancer Center
Tampa, Florida 33612

Florida Cancer Specialists - East
West Palm Beach, Florida 33401

Illinois Cancer Care
Peoria, Illinois 61615

OSF St. Francis Medical Center
Peoria, Illinois 61637

University of Iowa
Iowa City, Iowa 52242

University of Iowa Mission Health Cancer + Blood
Waukee, Iowa 50263

Norton Cancer Institute
Louisville, Kentucky 40202

American Oncology Partners, PA - The Center for Cancer and Blood Disorders
Bethesda, Maryland 20817

Maryland Oncology Hematology
Silver Spring, Maryland 20904

Henry Ford Health Cancer
Detroit, Michigan 48202

Missouri Cancer Associates
Columbia, Missouri 65201

Mercy South
St Louis, Missouri 63128

Stony Brook Cancer Center
Stony Brook, New York 11794-7007

Montefiore Medical Center
The Bronx, New York 10461

Cleveland Clinic - Akron General Medical Center
Akron, Ohio 44302

University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106

Cleveland Clinic - Fairview Hospital Molly Pavilion
Cleveland, Ohio 44111

Cleveland Clinic
Cleveland, Ohio 44195

Cleveland Clinic - Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio 44124

Consultants in Medical Oncology and Hematology
Broomall, Pennsylvania 19008

Alliance Cancer Specialists
Media, Pennsylvania 19063

Allegheny General Hospital
Pittsburgh, Pennsylvania 15212

University of Pittsburgh (UPMC) Hillman Cancer Center
Pittsburgh, Pennsylvania 15232

SCRI OP (Oncology Partners)
Nashville, Tennessee 37203

Texas Oncology - Central South
Austin, Texas 78745

University of Texas Southwestern Medical Center/Clinical Research Department
Dallas, Texas 75390-9020

Texas Oncology - West Texas
Odessa, Texas 79761

Virginia Cancer Specialists
Fairfax, Virginia 22031

More Details

Status
Recruiting
Sponsor
Zai Lab (Shanghai) Co., Ltd.

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.