A Phase 3 interventional study of ZL-1310 and Investigator's Choice of Therapy in Small-cell Lung Cancer, sponsored by Zai Lab (Shanghai) Co., Ltd.. Recruiting at 155 sites in 15 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by Zai Lab (Shanghai) Co., Ltd. · Phase 3, Interventional, and Treatment
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.
1,203 studies on the registry are indexed under Small Cell Lung Carcinoma; 342 are open to participants now.
This study's planned enrollment of 480 is above the median of 56 across 1,031 interventional studies indexed under Small Cell Lung Carcinoma.
Browse Small Cell Lung Carcinoma studies →Zai Lab (Shanghai) Co., Ltd. is the lead sponsor of 24 studies on the registry; 8 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
ZL-1310 as a single agent
Drug: ZL-1310
Investigator's Choice of Therapy
Drug: Investigator's Choice of Therapy
ZL-1310 as a single-agent
Topotecan or Amrubicin
Confirmed objective response rate (ORR) assessed by Blinded Independent Central Review of ZL-1310 compared to Investigator's Choice Therapy (ICT)
Time frame: up to 30 months
Overall survival of ZL-1310 compared to Investigator's Choice Therapy (ICT)
Time frame: up to 30 months
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)
Time frame: up to 30 months
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)
Time frame: up to 30 months
Confirmed ORR assessed by the investigator per RECIST v1.1 of ZL-1310 compared to Investigator's Choice Therapy (ICT)
Time frame: up to 30 months
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)
Time frame: up to 30 months
Confirmed CNS response assessed by BICR per Response Assessment in Neuro-Oncology for Brain Metastases (RANO-BM) of ZL-1310 compared to Investigator's Choice Therapy (ICT)
Time frame: up to 30 months
Occurrence of treatment-emergent adverse events (TEAEs) of ZL-1310 compared to Investigator's Choice Therapy (ICT)
Time frame: up to 30 months
Changes from baseline in quality of life related parameters of ZL-1310 compared to Investigator's Choice Therapy (ICT) using EQ-5D-5L
Time frame: up to 30 months
Changes from baseline in quality of life related parameters of ZL-1310 compared to Investigator's Choice Therapy (ICT) using EORTC-QLQ-C30
Time frame: up to 30 months
Changes from baseline in quality of life related parameters of ZL-1310 compared to Investigator's Choice Therapy (ICT) using EORTC-QLQ-LC13
Time frame: up to 30 months
Showing the first 100 of 155 sites across 15 countries.
Plan to share: No
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Zai Lab (Shanghai) Co., Ltd.