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NCT Number: NCT07218146

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Zai Lab Site 22002, Salzburg, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ZL-1310

Drug

ZL-1310 as a single-agent

Investigator's choice of therapy

Drug

Topotecan, Lurbinectedin, or Amrubicin

Primary outcomes

  1. Confirmed objective response rate (ORR) assessed by Blinded Independent Central Review of ZL-1310 compared to Investigator's Choice Therapy (ICT)

    Time frame: up to 27 months

  2. Overall survival of ZL-1310 compared to Investigator's Choice Therapy (ICT)

    Time frame: up to 27 months

Secondary outcomes

  1. Duration of response (DoR) assessed by BICR and by the investigator per RECIST v1.1 of ZL-1310 compared to Investigator's Choice Therapy (ICT)

    Time frame: up to 27 months

  2. Progression-free survival (PFS) assessed by BICR and by the investigator per RECIST v1.1 of ZL-1310 compared to Investigator's Choice Therapy (ICT)

    Time frame: up to 27 months

  3. Confirmed ORR assessed by the investigator per RECIST v1.1 of ZL-1310 compared to Investigator's Choice Therapy (ICT)

    Time frame: up to 27 months

  4. Time to response (TTR) assessed by BICR and by the investigator per RECIST v1.1 of ZL-1310 compared to Investigator's Choice Therapy (ICT)

    Time frame: up to 27 months

  5. Confirmed CNS response assessed by BICR per Response Assessment in Neuro-Oncology for Brain Metastases (RANO-BM) of ZL-1310 compared to Investigator's Choice Therapy (ICT)

    Time frame: up to 27 months

  6. Occurrence of treatment-emergent adverse events (TEAEs) of ZL-1310 compared to Investigator's Choice Therapy (ICT)

    Time frame: up to 27 months

  7. Changes from baseline in quality of life related parameters of ZL-1310 compared to Investigator's Choice Therapy (ICT) using EQ-5D-5L

    Time frame: up to 27 months

  8. Changes from baseline in quality of life related parameters of ZL-1310 compared to Investigator's Choice Therapy (ICT) using EORTC-QLQ-C30

    Time frame: up to 27 months

  9. Changes from baseline in quality of life related parameters of ZL-1310 compared to Investigator's Choice Therapy (ICT) using EORTC-QLQ-LC13

    Time frame: up to 27 months

Study contacts

Contact information is provided by the study sponsor or research team.

ZL-1310-003 Study Team

CONTACT

[email protected]

650-360-1601

Sponsors and collaborators

Lead sponsor

Zai Lab (Shanghai) Co., Ltd.

Industry

Collaborators

  • Zai Lab (US) LLC

Registry information

Official study title

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

Acronym: DLLEVATE

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Oct 20, 2025
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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