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
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.
Arms & interventions
- DrugZL-1310
ZL-1310 as a single-agent
- DrugInvestigator's Choice of Therapy
Topotecan, Lurbinectedin, or Amrubicin
Outcome measures
Primary
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 27 months
Overall survival of ZL-1310 compared to Investigator's Choice Therapy (ICT)
Time frame: up to 27 months
Secondary
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 27 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 27 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 27 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 27 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 27 months
Occurrence of treatment-emergent adverse events (TEAEs) of ZL-1310 compared to Investigator's Choice Therapy (ICT)
Time frame: up to 27 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 27 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 27 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 27 months
Eligibility criteria
Study locations (28)
Zai Lab Site 02037
Aurora, Colorado, 80045
Zai Lab Site 02030
New Haven, Connecticut, 06519
Zai Lab Site 02045
Clermont, Florida, 34711
Zai Lab Site 02031
Orange City, Florida, 32763
Zai Lab Site 02020
Rockledge, Florida, 32955
Zai Lab Site 02026
Sarasota, Florida, 34232
Zai Lab Site 02052
St. Petersburg, Florida, 33701-4553
Zai Lab Site 02051
West Palm Beach, Florida, 33401
Zai Lab Site 02021
Peoria, Illinois, 61615
Zai Lab Site 02049
Peoria, Illinois, 61637
Zai Lab Site 02038
Iowa City, Iowa, 52242
Zai Lab Site 02041
Louisville, Kentucky, 40202
Zai Lab Site 02003
Bethesda, Maryland, 20817
Zai Lab Site 02022
Silver Spring, Maryland, 20904
Zai Lab Site 02010
Detroit, Michigan, 48202
Zai Lab Site 02023
Columbia, Missouri, 65201
Zai Lab Site 02009
St Louis, Missouri, 63128
Zai Lab Site 02040
The Bronx, New York, 10461
Zai Lab Site 02024
Cleveland, Ohio, 44106
Zai Lab Site 02035
Broomall, Pennsylvania, 19008
Zai Lab Site 02019
Media, Pennsylvania, 19063
Zai Lab Site 02008
Pittsburgh, Pennsylvania, 15212
Zai Lab Site 02029
Pittsburgh, Pennsylvania, 15232
Zai Lab Site 02036
Nashville, Tennessee, 37203
Zai Lab Site 02025
Austin, Texas, 78745
Zai Lab Site 02046
Dallas, Texas, 75390-9020
Zai Lab Site 02025
Odessa, Texas, 79761
Zai Lab Site 02006
Fairfax, Virginia, 22031