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.
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.
Received more than one line of systemic therapy for Extensive-Stage SCLC.
Received any prior ADC with topoisomerase 1 inhibitor payload
Participants with another known malignancy with exceptions defined in the protocol.
History or suspected ILD/pneumonitis based on criteria per protocol
Parallel
ZL-1310
DrugZL-1310 as a single-agent
Investigator's Choice of Therapy
DrugTopotecan or Amrubicin
Confirmed objective response rate (ORR) assessed by Blinded Independent Central Review of ZL-1310 compared to Investigator's Choice Therapy (ICT)
Overall survival of ZL-1310 compared to Investigator's Choice Therapy (ICT)
Duration of response (DoR) assessed by BICR and by the investigator per RECIST v1.1 of ZL-1310 compared to Investigator's Choice Therapy (ICT)
Progression-free survival (PFS) assessed by BICR and by the investigator per RECIST v1.1 of ZL-1310 compared to Investigator's Choice Therapy (ICT)
Confirmed ORR assessed by the investigator per RECIST v1.1 of ZL-1310 compared to Investigator's Choice Therapy (ICT)
Time to response (TTR) assessed by BICR and by the investigator per RECIST v1.1 of ZL-1310 compared to Investigator's Choice Therapy (ICT)
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Zai Lab (Shanghai) Co., Ltd.
Lead sponsor
Zai Lab (US) LLC
Collaborator
