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RecruitingInterventionalPhase 3

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

NCT ID: NCT07218146Sponsor: Zai Lab (Shanghai) Co., Ltd.Last updated: 2026-05-14

Summary

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.

Arms & interventions

  • DrugZL-1310

    ZL-1310 as a single-agent

  • DrugInvestigator's Choice of Therapy

    Topotecan, Lurbinectedin, or Amrubicin

Outcome measures

Primary

  • 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

  • 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

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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.

Study locations (28)

Zai Lab Site 02037

Aurora, Colorado, 80045

Recruiting

Zai Lab Site 02030

New Haven, Connecticut, 06519

Recruiting

Zai Lab Site 02045

Clermont, Florida, 34711

Recruiting

Zai Lab Site 02031

Orange City, Florida, 32763

Recruiting

Zai Lab Site 02020

Rockledge, Florida, 32955

Recruiting

Zai Lab Site 02026

Sarasota, Florida, 34232

Recruiting

Zai Lab Site 02052

St. Petersburg, Florida, 33701-4553

Recruiting

Zai Lab Site 02051

West Palm Beach, Florida, 33401

Recruiting

Zai Lab Site 02021

Peoria, Illinois, 61615

Recruiting

Zai Lab Site 02049

Peoria, Illinois, 61637

Recruiting

Zai Lab Site 02038

Iowa City, Iowa, 52242

Recruiting

Zai Lab Site 02041

Louisville, Kentucky, 40202

Recruiting

Zai Lab Site 02003

Bethesda, Maryland, 20817

Recruiting

Zai Lab Site 02022

Silver Spring, Maryland, 20904

Recruiting

Zai Lab Site 02010

Detroit, Michigan, 48202

Recruiting

Zai Lab Site 02023

Columbia, Missouri, 65201

Recruiting

Zai Lab Site 02009

St Louis, Missouri, 63128

Recruiting

Zai Lab Site 02040

The Bronx, New York, 10461

Recruiting

Zai Lab Site 02024

Cleveland, Ohio, 44106

Recruiting

Zai Lab Site 02035

Broomall, Pennsylvania, 19008

Recruiting

Zai Lab Site 02019

Media, Pennsylvania, 19063

Recruiting

Zai Lab Site 02008

Pittsburgh, Pennsylvania, 15212

Recruiting

Zai Lab Site 02029

Pittsburgh, Pennsylvania, 15232

Recruiting

Zai Lab Site 02036

Nashville, Tennessee, 37203

Recruiting

Zai Lab Site 02025

Austin, Texas, 78745

Recruiting

Zai Lab Site 02046

Dallas, Texas, 75390-9020

Recruiting

Zai Lab Site 02025

Odessa, Texas, 79761

Recruiting

Zai Lab Site 02006

Fairfax, Virginia, 22031

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