NCT07218146

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 480 (estimated)
• Sponsor: Zai Lab (Shanghai) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Small-cell Lung Cancer

Interventions

Type	Name	Description
DRUG	ZL-1310	ZL-1310 as a single-agent
DRUG	Investigator's Choice of Therapy	Topotecan, Lurbinectedin, or Amrubicin

Timeline

• Start date: 2025-11-30
• Primary completion: 2028-06-30
• Completion: 2028-11-30
• First posted: 2025-10-20
• Last updated: 2026-03-13

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated drug study