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Clinical Trials in the UK / NCT07218146
Recruiting Phase 3

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

NCT07218146 · tracked via the Priya Life Science UK tracker
Sponsor
Zai Lab (Shanghai) Co., Ltd.
Phase
Phase 3
Started
2025-11-30
Last updated
2026-09-14

Condition(s) studied

Small-cell Lung Cancer

Investigational drug(s) / intervention(s)

ZL-1310Investigator's Choice of Therapy

ZL-1310: ZL-1310 as a single-agent

Investigator's Choice of Therapy: Topotecan or Amrubicin

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

Sex
ALL
Min age
18 Years
Max age
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.

Primary outcome measure(s)

Trial sites (155)

FacilityCityRegionStatus
University of California San Diego La Jolla California Recruiting
UC Davis Comprehensive Cancer Center Sacramento California Recruiting
University of Colorado Aurora Colorado Recruiting
Yale Cancer Center/Clinical Trials Office New Haven Connecticut Recruiting
Clermont Oncology Center Clermont Florida Recruiting
Mid Florida Hematology and Oncology Center Orange City Florida Recruiting
Cancer Centers of Bevard Rockledge Florida Recruiting
Sarah Cannon Research Institute Sarasota Florida Recruiting
Florida Cancer Specialists - North St. Petersburg Florida Recruiting
Moffitt Cancer Center Tampa Florida Recruiting
Florida Cancer Specialists - East West Palm Beach Florida Recruiting
Illinois Cancer Care Peoria Illinois Recruiting
OSF St. Francis Medical Center Peoria Illinois Recruiting
University of Iowa Iowa City Iowa Recruiting
University of Iowa Mission Health Cancer + Blood Waukee Iowa Recruiting
Norton Cancer Institute Louisville Kentucky Recruiting
American Oncology Partners, PA - The Center for Cancer and Blood Disorders Bethesda Maryland Recruiting
Maryland Oncology Hematology Silver Spring Maryland Recruiting
Henry Ford Health Cancer Detroit Michigan Recruiting
Missouri Cancer Associates Columbia Missouri Recruiting
Mercy South St Louis Missouri Recruiting
Stony Brook Cancer Center Stony Brook New York Recruiting
Montefiore Medical Center The Bronx New York Recruiting
Cleveland Clinic - Akron General Medical Center Akron Ohio Recruiting
University Hospitals Cleveland Medical Center Cleveland Ohio Recruiting
Cleveland Clinic - Fairview Hospital Molly Pavilion Cleveland Ohio Recruiting
Cleveland Clinic Cleveland Ohio Recruiting
Cleveland Clinic - Hillcrest Hospital Cancer Center Mayfield Heights Ohio Recruiting
Consultants in Medical Oncology and Hematology Broomall Pennsylvania Recruiting
Alliance Cancer Specialists Media Pennsylvania Recruiting
Allegheny General Hospital Pittsburgh Pennsylvania Recruiting
University of Pittsburgh (UPMC) Hillman Cancer Center Pittsburgh Pennsylvania Recruiting
SCRI OP (Oncology Partners) Nashville Tennessee Recruiting
Texas Oncology - Central South Austin Texas Recruiting
University of Texas Southwestern Medical Center/Clinical Research Department Dallas Texas Recruiting
Texas Oncology - West Texas Odessa Texas Recruiting
Virginia Cancer Specialists Fairfax Virginia Recruiting
Uniklinikum Salzburg, Landeskrankenhaus, Universitatsklinik fur Innere Medizin III der PMU Department of Internal Medicine III Salzburg Austria Recruiting
Universitair Ziekenhuis Antwerpen Edegem Belgium Recruiting
Algemeen Ziekenhuis Sint-Lucas Ghent Belgium Recruiting

+ 115 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07218146 on ClinicalTrials.gov ↗ ← All trials in the UK