Skip to Main Content
Phase III

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

  • Study HIC#:2000041311
  • Last Updated:04/08/2026

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.

    Contact Us

    For more information about this study, including how to volunteer, contact:

    Help Us Discover!

    You can help our team find trials you might be eligible for by creating a volunteer profile in MyChart. To get started, create a volunteer profile, or contact helpusdiscover@yale.edu, or call +18779788343 for more information.

    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.

    Principal Investigator

    For more information about this study, including how to volunteer, contact: