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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
Location: See all (56) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• 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 function
• Eastern Cooperative Group (ECOG) performance status of 0 or 1
• Life expectancy of at least 3 months
• Participants must be willing to undergo a tumor biopsy or provide archived tumor tissue sample at Screening
• Participants must be willing and able to comply with protocol for the duration of the study