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Recruiting NCT07218146

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

Phase III Interventional Small-cell Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ZL-1310, Investigator's Choice of Therapy.
Who it may be relevant to
Registry conditions: Small-cell Lung Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Austria, China, Japan, Netherlands +3
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

Interventions

  • Drug ZL-1310
    ZL-1310 as a single-agent
  • Drug Investigator's Choice of Therapy
    Topotecan, Lurbinectedin, or Amrubicin

Primary outcome measures

  • 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]
  • Overall survival of ZL-1310 compared to Investigator's Choice Therapy (ICT) [Time frame: up to 27 months]
Secondary outcome measures (9)
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • Occurrence of treatment-emergent adverse events (TEAEs) of ZL-1310 compared to Investigator's Choice Therapy (ICT) [Time frame: up to 27 months]
  • 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]
  • 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]
  • 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]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 31 centers
  • Zai Lab Site 02050 — La Jolla
  • Zai Lab Site 02033 — Sacramento
  • Zai Lab Site 02037 — Aurora
  • Zai Lab Site 02030 — New Haven
  • Zai Lab Site 02045 — Clermont
  • Zai Lab Site 02031 — Orange City
  • Zai Lab Site 02020 — Rockledge
  • Zai Lab Site 02026 — Sarasota
  • … and 23 more centers
China · 18 centers
  • Zai Lab Site 01002 — Hefei
  • Zai Lab Site 01014 — Xiamen
  • Zai Lab Site 01001 — Guangzhou
  • Zai Lab Site 01011 — Naning
  • Zai Lab Site 01022 — Heilongjiang
  • Zai Lab Site 01008 — Shijiazhuang
  • Zai Lab Site 01010 — Zhengzhou
  • Zai Lab Site 01034 — Wuhan
  • … and 10 more centers
Japan · 16 centers
  • Zai Lab Site 10018 — Fukuoka
  • Zai Lab Site 10017 — Fukuoka
  • Zai Lab Site 10019 — Kurume
  • Zai Lab Site 10016 — Hiroshima
  • Zai Lab Site 10009 — Yokohama
  • Zai Lab Site 10015 — Kashihara
  • Zai Lab Site 10011 — Hirakata
  • Zai Lab Site 10014 — Izumi
  • … and 8 more centers
Turkey (Türkiye) · 4 centers
  • Zai Lab Site 14013 — Adana
  • Zai Lab Site 14014 — Ankara
  • Zai Lab Site 14012 — Istanbul
  • Zai Lab Site 14003 — Istanbul
United Kingdom · 4 centers
  • Zai Lab Site 21003 — London
  • Zai Lab Site 21011 — Chelsea
  • Zai Lab Site 21012 — Sutton
  • Zai Lab Site 21001 — Stoke-on-Trent
Austria · 1 center
  • Zai Lab Site 22002 — Salzburg
Netherlands · 1 center
  • Zai Lab Site 20004 — Hilversum
Spain · 1 center
  • Zai Lab Site 08032 — Valencia

Identifiers

NCT: NCT07218146 · ZL-1310-003

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗