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
Zai Lab (Shanghai) Co., Ltd.
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy 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 functio…
Interventions
- DrugZL-1310
ZL-1310 as a single-agent
- DrugInvestigator's Choice of Therapy
Topotecan, Lurbinectedin, or Amrubicin
Locations (34)
- Zai Lab Site 02030New Haven, Connecticut
- Zai Lab Site 02045Clermont, Florida
- Zai Lab Site 02031Orange City, Florida
- Zai Lab Site 02020Rockledge, Florida
- Zai Lab Site 02026Sarasota, Florida
- Zai Lab Site 02021Peoria, Illinois