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Study identifier: NCT07218146 Synced from ClinicalTrials.gov · August 08, 2026
● Study status: RecruitingDLLEVATE

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

Condition: Small-cell Lung Cancer  ·  Sponsor: Zai Lab (Shanghai) Co., Ltd.

PhasePhase 3
Planned participants480
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNoCheck eligibility criteria ↓
Where76 locations · 8 countries

Interested? Contact the study team ↓

For sponsors, CROs & site teams
Professional view of this study — listed sites, countries and recruiting context from the public registry. Everything below is written for patients and caregivers.See where this study is running →

About this 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.

This description comes directly from the study's public registry record.

Talk to the study team

ZL-1310-003 Study Team  ·  650-360-1601  ·  study-ZL-1310-003@zailaboratory.com

There is no obligation to join — the study team can answer your questions about taking part.

Always discuss trial participation with your own doctor first.

Full eligibility criteria (exactly as the study team wrote them)

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.

Reproduced word-for-word from the public registry record — the study team can answer questions about it.

Locations (76)

Zai Lab Site 02050La Jolla, California, United StatesRecruiting
Zai Lab Site 02033Sacramento, California, United StatesRecruiting
Zai Lab Site 02037Aurora, Colorado, United StatesRecruiting
Zai Lab Site 02030New Haven, Connecticut, United StatesRecruiting
Zai Lab Site 02045Clermont, Florida, United StatesRecruiting
Zai Lab Site 02031Orange City, Florida, United StatesRecruiting
Zai Lab Site 02020Rockledge, Florida, United StatesRecruiting
Zai Lab Site 02026Sarasota, Florida, United StatesRecruiting
Zai Lab Site 02052St. Petersburg, Florida, United StatesRecruiting
Zai Lab Site 02047Tampa, Florida, United StatesRecruiting
Zai Lab Site 02051West Palm Beach, Florida, United StatesRecruiting
Zai Lab Site 02021Peoria, Illinois, United StatesRecruiting

+ 64 more locations — full list on the registry record.

More studies in these areas

This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.

La JollaSacramentoAuroraNew Haven

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