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

RecruitingPhase 3

A Randomized, Open-Label, Phase 3 Study of ZL-1310, a DLL3 Antibody-Drug Conjugate (ADC), Compared to Investigator's Choice Therapy in Participants With Relapsed Small Cell Lung Cancer

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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.

About the study

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.

What is being tested

Sponsor: Zai Lab (Shanghai) Co., Ltd. · Participants: 480 · Started: Nov 30, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07218146

Locations in the U.S.

CaliforniaUniversity of California San Diego, La Jolla
UC Davis Comprehensive Cancer Center, Sacramento
ColoradoUniversity of Colorado, Aurora
ConnecticutYale Cancer Center/Clinical Trials Office, New Haven
FloridaClermont Oncology Center, Clermont
Mid Florida Hematology and Oncology Center, Orange City
Cancer Centers of Bevard, Rockledge
Sarah Cannon Research Institute, Sarasota
Florida Cancer Specialists - North, St. Petersburg
Moffitt Cancer Center, Tampa
Florida Cancer Specialists - East, West Palm Beach
IllinoisIllinois Cancer Care, Peoria
OSF St. Francis Medical Center, Peoria
IowaUniversity of Iowa, Iowa City
University of Iowa Mission Health Cancer + Blood, Waukee
KentuckyNorton Cancer Institute, Louisville
MarylandAmerican Oncology Partners, PA - The Center for Cancer and Blood Disorders, Bethesda
Maryland Oncology Hematology, Silver Spring
MichiganHenry Ford Health Cancer, Detroit
MissouriMissouri Cancer Associates, Columbia
Mercy South, St Louis
New YorkStony Brook Cancer Center, Stony Brook
Montefiore Medical Center, The Bronx
OhioCleveland Clinic - Akron General Medical Center, Akron
Cleveland Clinic, Cleveland
Cleveland Clinic - Fairview Hospital Molly Pavilion, Cleveland
University Hospitals Cleveland Medical Center, Cleveland
Cleveland Clinic - Hillcrest Hospital Cancer Center, Mayfield Heights
PennsylvaniaConsultants in Medical Oncology and Hematology, Broomall
Alliance Cancer Specialists, Media
Allegheny General Hospital, Pittsburgh
University of Pittsburgh (UPMC) Hillman Cancer Center, Pittsburgh
TennesseeSCRI OP (Oncology Partners), Nashville
TexasTexas Oncology - Central South, Austin
University of Texas Southwestern Medical Center/Clinical Research Department, Dallas
Texas Oncology - West Texas, Odessa
VirginiaVirginia Cancer Specialists, Fairfax

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.