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

Part of paid clinical trials in La Jolla, California.

Sponsor
Zai Lab (Shanghai) Co., Ltd.
Study ID
NCT07218146
Phase
PHASE3
Status
Recruiting
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Conditions

  • Small-cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ZL-1310 — DRUG
    ZL-1310 as a single-agent
  • Investigator's Choice of Therapy — DRUG
    Topotecan or Amrubicin

Study Details

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.

Key Dates

First listed
Oct 20, 2025
Start date
Nov 30, 2025
Status verified
Sep 2026
Primary completion
Jun 30, 2028
Completion
Nov 30, 2028

Study Design

Enrollment
480 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
    ZL-1310 as a single agent
  • Active Comparator: Arm 2
    Investigator's Choice of Therapy

Primary Outcome Measure

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 30 months ]

Central Contacts

Locations (37)

FacilityCityStateZIPSite coordinators
University of California San DiegoLa JollaCalifornia92093-
UC Davis Comprehensive Cancer CenterSacramentoCalifornia95817-
University of ColoradoAuroraColorado80045-
Yale Cancer Center/Clinical Trials OfficeNew HavenConnecticut06519-
Clermont Oncology CenterClermontFlorida34711-
Mid Florida Hematology and Oncology CenterOrange CityFlorida32763-
Cancer Centers of BevardRockledgeFlorida32955-
Sarah Cannon Research InstituteSarasotaFlorida34232-
Florida Cancer Specialists - NorthSt. PetersburgFlorida33701-4553-
Moffitt Cancer CenterTampaFlorida33612-
Florida Cancer Specialists - EastWest Palm BeachFlorida33401-
Illinois Cancer CarePeoriaIllinois61615-
OSF St. Francis Medical CenterPeoriaIllinois61637-
University of IowaIowa CityIowa52242-
University of Iowa Mission Health Cancer + BloodWaukeeIowa50263-
Norton Cancer InstituteLouisvilleKentucky40202-
American Oncology Partners, PA - The Center for Cancer and Blood DisordersBethesdaMaryland20817-
Maryland Oncology HematologySilver SpringMaryland20904-
Henry Ford Health CancerDetroitMichigan48202-
Missouri Cancer AssociatesColumbiaMissouri65201-
Mercy SouthSt LouisMissouri63128-
Stony Brook Cancer CenterStony BrookNew York11794-7007-
Montefiore Medical CenterThe BronxNew York10461-
Cleveland Clinic - Akron General Medical CenterAkronOhio44302-
Cleveland ClinicClevelandOhio44195-
Cleveland Clinic - Fairview Hospital Molly PavilionClevelandOhio44111-
University Hospitals Cleveland Medical CenterClevelandOhio44106-
Cleveland Clinic - Hillcrest Hospital Cancer CenterMayfield HeightsOhio44124-
Consultants in Medical Oncology and HematologyBroomallPennsylvania19008-
Alliance Cancer SpecialistsMediaPennsylvania19063-
Allegheny General HospitalPittsburghPennsylvania15212-
University of Pittsburgh (UPMC) Hillman Cancer CenterPittsburghPennsylvania15232-
SCRI OP (Oncology Partners)NashvilleTennessee37203-
Texas Oncology - Central SouthAustinTexas78745-
University of Texas Southwestern Medical Center/Clinical Research DepartmentDallasTexas75390-9020-
Texas Oncology - West TexasOdessaTexas79761-
Virginia Cancer SpecialistsFairfaxVirginia22031-

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By research site
University of California San Diego· La Jolla, CAUC Davis Comprehensive Cancer Center· Sacramento, CAUniversity of Colorado· Aurora, COYale Cancer Center/Clinical Trials Office· New Haven, CTClermont Oncology Center· Clermont, FLMid Florida Hematology and Oncology Center· Orange City, FL

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