A Study of ZL-1310 Versus Investigator's Choice of Therapy in Participants With Relapsed Small Cell Lung Cancer (DLLEVATE)
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
- Small-cell Lung Cancer
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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Arm 1 |
ZL-1310 as a single agent |
|
|
Active Comparator Arm 2 |
Investigator's Choice of Therapy |
|
Recruiting Locations
University of California San Diego
La Jolla, California 92093
La Jolla, California 92093
UC Davis Comprehensive Cancer Center
Sacramento, California 95817
Sacramento, California 95817
University of Colorado
Aurora, Colorado 80045
Aurora, Colorado 80045
Yale Cancer Center/Clinical Trials Office
New Haven, Connecticut 06519
New Haven, Connecticut 06519
Clermont Oncology Center
Clermont, Florida 34711
Clermont, Florida 34711
Mid Florida Hematology and Oncology Center
Orange City, Florida 32763
Orange City, Florida 32763
Cancer Centers of Bevard
Rockledge, Florida 32955
Rockledge, Florida 32955
Sarah Cannon Research Institute
Sarasota, Florida 34232
Sarasota, Florida 34232
Florida Cancer Specialists - North
St. Petersburg, Florida 33701-4553
St. Petersburg, Florida 33701-4553
Moffitt Cancer Center
Tampa, Florida 33612
Tampa, Florida 33612
Florida Cancer Specialists - East
West Palm Beach, Florida 33401
West Palm Beach, Florida 33401
Illinois Cancer Care
Peoria, Illinois 61615
Peoria, Illinois 61615
OSF St. Francis Medical Center
Peoria, Illinois 61637
Peoria, Illinois 61637
University of Iowa
Iowa City, Iowa 52242
Iowa City, Iowa 52242
University of Iowa Mission Health Cancer + Blood
Waukee, Iowa 50263
Waukee, Iowa 50263
Norton Cancer Institute
Louisville, Kentucky 40202
Louisville, Kentucky 40202
American Oncology Partners, PA - The Center for Cancer and Blood Disorders
Bethesda, Maryland 20817
Bethesda, Maryland 20817
Maryland Oncology Hematology
Silver Spring, Maryland 20904
Silver Spring, Maryland 20904
Henry Ford Health Cancer
Detroit, Michigan 48202
Detroit, Michigan 48202
Missouri Cancer Associates
Columbia, Missouri 65201
Columbia, Missouri 65201
Mercy South
St Louis, Missouri 63128
St Louis, Missouri 63128
Stony Brook Cancer Center
Stony Brook, New York 11794-7007
Stony Brook, New York 11794-7007
Montefiore Medical Center
The Bronx, New York 10461
The Bronx, New York 10461
Cleveland Clinic - Akron General Medical Center
Akron, Ohio 44302
Akron, Ohio 44302
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
Cleveland, Ohio 44106
Cleveland Clinic - Fairview Hospital Molly Pavilion
Cleveland, Ohio 44111
Cleveland, Ohio 44111
Cleveland Clinic
Cleveland, Ohio 44195
Cleveland, Ohio 44195
Cleveland Clinic - Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio 44124
Mayfield Heights, Ohio 44124
Consultants in Medical Oncology and Hematology
Broomall, Pennsylvania 19008
Broomall, Pennsylvania 19008
Alliance Cancer Specialists
Media, Pennsylvania 19063
Media, Pennsylvania 19063
Allegheny General Hospital
Pittsburgh, Pennsylvania 15212
Pittsburgh, Pennsylvania 15212
University of Pittsburgh (UPMC) Hillman Cancer Center
Pittsburgh, Pennsylvania 15232
Pittsburgh, Pennsylvania 15232
SCRI OP (Oncology Partners)
Nashville, Tennessee 37203
Nashville, Tennessee 37203
Texas Oncology - Central South
Austin, Texas 78745
Austin, Texas 78745
University of Texas Southwestern Medical Center/Clinical Research Department
Dallas, Texas 75390-9020
Dallas, Texas 75390-9020
Texas Oncology - West Texas
Odessa, Texas 79761
Odessa, Texas 79761
Virginia Cancer Specialists
Fairfax, Virginia 22031
Fairfax, Virginia 22031
More Details
- Status
- Recruiting
- Sponsor
- Zai Lab (Shanghai) Co., Ltd.