RecruitingPhase 3NCT07218146

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

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.

Checked against the public recordLast updated Aug 17, 2026 · Source: ClinicalTrials.gov

StatusRecruiting
PhasePhase 3
U.S. locations111
SponsorZai Lab (Shanghai) Co., Ltd.
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 3
Sponsor
Zai Lab (Shanghai) Co., Ltd.
Interventions being studied
Drug: ZL-1310; Drug: Investigator's Choice of Therapy
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

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

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 17, 2026. Always confirm current availability with the study team.

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