Actively Recruiting
A Randomized, Open-Label, Phase 3 Study of ZL-1310, a DLL3 Antibody-Drug Conjugate, Compared to Investigators Choice Therapy in Participants With Relapsed Small Cell Lung Cancer
Led by Zai Lab (Shanghai) Co., Ltd. · Updated on 2026-07-20
480
Participants Needed
76
Research Sites
21 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of ZL-1310 compared to Investigators Choice Therapy in adults with relapsed Small Cell Lung Cancer SCLC. This phase 3, randomized, open-label study aims to compare treatment responses and overall survival between these two therapies in participants who have previously received platinum-based systemic therapy or tarlatamab. Participants are randomly assigned to receive either ZL-1310 as a single-agent drug or Investigators Choice Therapy, which includes Topotecan, Lurbinectedin, or Amrubicin. The study follows a parallel design and monitors participants during treatment and follow-up periods lasting up to 27 months to assess various outcomes. During the study, participants undergo regular evaluations including tumor assessments based on RECIST v1.1 criteria, brain metastases response evaluations, and quality of life measurements using validated questionnaires. Safety is closely monitored by tracking treatment-emergent adverse events. Participants are expected to comply with study procedures, including tumor biopsies or providing archived tissue samples, and the total study duration may extend to nearly three years.
CONDITIONS
Brief Title
A Study of ZL-1310 Versus Investigator's Choice of Therapy in Participants With Relapsed Small Cell Lung Cancer (DLLEVATE)
Research Team
Z
ZL-1310-003 Study Team
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