DLLEVATE
Research type
Research Study
Full title
A Randomized, Open-Label, Phase 3 Study of ZL-1310, a DLL3 Antibody-Drug Conjugate (ADC), Compared to Investigator’s Choice Chemotherapy in Participants with Relapsed Small Cell Lung Cancer
IRAS ID
1012705
Contact name
Yun Wang
Contact email
Sponsor organisation
Zai Lab (US) LLC
Eudract number
2025-522818-23
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to test a medication called ZL-1310, (which is not yet approved for market) in treating advanced small cell lung cancer which has progressed after standard first-line treatment. This will be done, by comparing the effectiveness of for ZL-1310 with standardly-used existing chemotherapy agents for this indication (referred to as ICT or ‘investigator’s choice therapy’).
ZL-1310 will be provided as an intravenous (IV) infusion every 3 weeks.
Participants will be randomly assigned in a 1:1 ratio to either the ZL-1310 1.6 mg/kg or ICT arms. This process is called randomisation, to make sure the results of the study cannot be unfairly influenced by anyone.
Participants will receive the study medication or ICT for as long as they are deriving benefits. Participants may stop receiving the study treatment for any of the following reasons:
-the study test results show that their condition is getting worse
-the study doctor thinks that they are no longer benefitting from the study treatment
-participants have a side effect that becomes too severe
-participants choose to stop the study treatment.They will then have an ‘End of Treatment’ visit within 7 days after ending, and then a visit within 30 days to evaluate for any residual side effects.
Site staff will contact participants by telephone approximately every 12 weeks after their last treatment dose on the study to check on their health and for survival follow-up.
The overall study duration is approximately 39 months.
The study is planned to involve approximately 12 participants from the UK.REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
26/NE/0034
Date of REC Opinion
18 Mar 2026
REC opinion
Further Information Favourable Opinion