A Study of ZL-1310 Versus Investigator's Choice of Therapy in Participants With Relapsed Small Cell Lung Cancer (DLLEVATE)
Recruiting · NCT07218146 · Interventional (participants receive a specific treatment) · Lead sponsor: Zai Lab (Shanghai) Co., Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
Investigator's Choice of TherapyZL-1310
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
60 locations listed across 16 US states.
- University of California San Diego - La Jolla, California, United States
- UC Davis Comprehensive Cancer Center - Sacramento, California, United States
- University of Colorado - Aurora, Colorado, United States
- Yale Cancer Center/Clinical Trials Office - New Haven, Connecticut, United States
- Clermont Oncology Center - Clermont, Florida, United States
- Mid Florida Hematology and Oncology Center - Orange City, Florida, United States
- Cancer Centers of Bevard - Rockledge, Florida, United States
- Sarah Cannon Research Institute - Sarasota, Florida, United States
- Florida Cancer Specialists - North - St. Petersburg, Florida, United States
- Moffitt Cancer Center - Tampa, Florida, United States
- Florida Cancer Specialists - East - West Palm Beach, Florida, United States
- Illinois Cancer Care - Peoria, Illinois, United States
- OSF St. Francis Medical Center - Peoria, Illinois, United States
- University of Iowa - Iowa City, Iowa, United States
- University of Iowa Mission Health Cancer + Blood - Waukee, Iowa, United States
- Norton Cancer Institute - Louisville, Kentucky, United States
- American Oncology Partners, PA - The Center for Cancer and Blood Disorders - Bethesda, Maryland, United States
- Maryland Oncology Hematology - Silver Spring, Maryland, United States
- Henry Ford Health Cancer - Detroit, Michigan, United States
- Missouri Cancer Associates - Columbia, Missouri, United States
- Mercy South - St Louis, Missouri, United States
- Stony Brook Cancer Center - Stony Brook, New York, United States
- Montefiore Medical Center - The Bronx, New York, United States
- Cleveland Clinic - Akron General Medical Center - Akron, Ohio, United States
- University Hospitals Cleveland Medical Center - Cleveland, Ohio, United States
- Cleveland Clinic - Fairview Hospital Molly Pavilion - Cleveland, Ohio, United States
- Cleveland Clinic - Cleveland, Ohio, United States
- Cleveland Clinic - Hillcrest Hospital Cancer Center - Mayfield Heights, Ohio, United States
- Consultants in Medical Oncology and Hematology - Broomall, Pennsylvania, United States
- Alliance Cancer Specialists - Media, Pennsylvania, United States
- Allegheny General Hospital - Pittsburgh, Pennsylvania, United States
- University of Pittsburgh (UPMC) Hillman Cancer Center - Pittsburgh, Pennsylvania, United States
- SCRI OP (Oncology Partners) - Nashville, Tennessee, United States
- Texas Oncology - Central South - Austin, Texas, United States
- University of Texas Southwestern Medical Center/Clinical Research Department - Dallas, Texas, United States
- Texas Oncology - West Texas - Odessa, Texas, United States
- Virginia Cancer Specialists - Fairfax, Virginia, United States
- Medical Park Seyhan Hospital - Adana, Turkey (Türkiye)
- Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I - Ancona, Italy
- Liv Hospital Ankara - Ankara, Turkey (Türkiye)
- Institut Sainte Catherine - Avignon, France
- UOMI Cancer Center-Clinica Tres Torres - Barcelona, Spain
- Hospital Clinic de Barcelona (Hospital Clinic i Provincial) - Barcelona, Spain
- Cancer Hospital Chinese Academy of Medical Sciences - Beijing, China
- Beijing Cancer Hospital - Beijing, China
- Evangelische Lungenklinik Berlin - Berlin, Germany
- Amphia Ziekenhuis - Breda, Netherlands
- Hospices Civils de Lyon - Hopital Louis Pradel - Bron, France
- FPO IRCCS Candiolo - Candiolo, Italy
- Centre Hospitalier Intercommunal de Creteil (CHIC) - Centre de ressources et de competences pour la mucoviscidose (C.R.C.M.) - Créteil, France
- University Hospital Carl Gustav Carus - Dresden, Germany
- Universitair Ziekenhuis Antwerpen - Edegem, Belgium
- Hospital General Universitario de Elche - Elche, Spain
- Algemeen Ziekenhuis Sint-Lucas - Ghent, Belgium
- AZ Maria Middelares - Campus AZ Maria Middelares - Ghent, Belgium
- Institut Catala d'Oncologia GIRONA - Girona, Spain
- Krankenhaus Martha-Maria Halle-Doelau gGmbH - Halle, Germany
- Jessa Ziekenhuis Salvador - Hasselt, Belgium
- Tergooi Ziekenhuizen - Hilversum, Netherlands
- Nemocnice Horovice - Hořovice, Czechia
Showing 60 of 155 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →