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

NCT07218146

RecruitingPhase 3

Sponsor: Zai Lab (Shanghai) Co., Ltd.

Conditions: Small-cell Lung Cancer

Interventions: ZL-1310, Investigator's Choice of Therapy

Countries: United States, Austria, Belgium, China, France, Germany, Italy, Japan

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (111)

La Jolla, California, United States
Sacramento, California, United States
Aurora, Colorado, United States
New Haven, Connecticut, United States
Clermont, Florida, United States
Orange City, Florida, United States
Rockledge, Florida, United States
Sarasota, Florida, United States
St. Petersburg, Florida, United States
Tampa, Florida, United States
West Palm Beach, Florida, United States
Peoria, Illinois, United States
Peoria, Illinois, United States
Iowa City, Iowa, United States
Louisville, Kentucky, United States
Bethesda, Maryland, United States
Silver Spring, Maryland, United States
Detroit, Michigan, United States
Columbia, Missouri, United States
St Louis, Missouri, United States
The Bronx, New York, United States
Cleveland, Ohio, United States
Cleveland, Ohio, United States
Broomall, Pennsylvania, United States
Media, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Nashville, Tennessee, United States
Austin, Texas, United States
Dallas, Texas, United States
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