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 Aurora, Colorado.

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, Lurbinectedin, 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

Start date
Nov 30, 2025
Status verified
May 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 27 months ]

Central Contacts

Locations (28)

FacilityCityStateZIPSite coordinators
Zai Lab Site 02037AuroraColorado80045-
Zai Lab Site 02030New HavenConnecticut06519-
Zai Lab Site 02045ClermontFlorida34711-
Zai Lab Site 02031Orange CityFlorida32763-
Zai Lab Site 02020RockledgeFlorida32955-
Zai Lab Site 02026SarasotaFlorida34232-
Zai Lab Site 02052St. PetersburgFlorida33701-4553-
Zai Lab Site 02051West Palm BeachFlorida33401-
Zai Lab Site 02021PeoriaIllinois61615-
Zai Lab Site 02049PeoriaIllinois61637-
Zai Lab Site 02038Iowa CityIowa52242-
Zai Lab Site 02041LouisvilleKentucky40202-
Zai Lab Site 02003BethesdaMaryland20817-
Zai Lab Site 02022Silver SpringMaryland20904-
Zai Lab Site 02010DetroitMichigan48202-
Zai Lab Site 02023ColumbiaMissouri65201-
Zai Lab Site 02009St LouisMissouri63128-
Zai Lab Site 02040The BronxNew York10461-
Zai Lab Site 02024ClevelandOhio44106-
Zai Lab Site 02035BroomallPennsylvania19008-
Zai Lab Site 02019MediaPennsylvania19063-
Zai Lab Site 02008PittsburghPennsylvania15212-
Zai Lab Site 02029PittsburghPennsylvania15232-
Zai Lab Site 02036NashvilleTennessee37203-
Zai Lab Site 02025AustinTexas78745-
Zai Lab Site 02046DallasTexas75390-9020-
Zai Lab Site 02025OdessaTexas79761-
Zai Lab Site 02006FairfaxVirginia22031-

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