The purpose of this study is to evaluate the efficacy and safety of ZL-1310 in combination with a checkpoint inhibitor compared to standard first-line therapy in participants with Extensive-Stage Small Cell Lung Cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
530
ZL-1310 ADC in combination with checkpoint inhibitor
Platinum-based chemotherapy in combination with a checkpoint inhibitor
Overall survival of ZL-1310 with IO compared to chemo with IO
Time frame: up to approximately 3 years
Progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR) and by investigator per RECIST v1.1 of ZL-1310 with IO compared to chemo with IO
Time frame: up to approximately 3 years
Confirmed objective response rate (ORR) assessed by BICR and by investigator per RECIST v1.1 of ZL-1310 with IO compared to chemo with IO
Time frame: up to approximately 3 years
Duration of response (DoR) assessed by BICR and by the investigator per RECIST v1.1 of ZL-1310with IO compared to chemo with IO
Time frame: up to approximately 3 years
Time to response (TTR) assessed by BICR and by the investigator per RECIST v1.1 of ZL-1310 with IO compared to chemo with IO
Time frame: up to approximately 3 years
Confirmed central nervous system response assessed by BICR and by the investigator per modified Response Assessment in Neuro-Oncology for Brain Metastases in participants with brain metastases at baseline of ZL-1310 with IO compared to chemo with IO
Time frame: up to approximately 3 years
Duration of central nervous system response assessed by BICR and by the investigator per modified Response Assessment in Neuro-Oncology for Brain Metastases in participants with brain metastases at baseline of ZL-1310 with IO compared to chemo with IO
Time frame: up to approximately 3 years
Incidence rate of new brain metastases in participants without baseline brain metastases of ZL-1310 with IO compared to chemo with IO
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Standard of Care Platinum-based chemotherapy in combination
Time frame: up to approximately 3 years
Time to first onset of new brain metastases in participants without baseline brain metastases of ZL-130
Time frame: up to approximately 3 years
Changes from baseline in quality of life related parameters of ZL-1310 with IO compared to chemo with IO using EQ-5D (EQ-5D-5L index)
Time frame: up to approximately 3 years
Changes from baseline in quality of life related parameters of ZL-1310 with IO compared to chemo with IO using EQ-5D (EQ visual analog scale [VAS]).
Time frame: up to approximately 3 years
Changes from baseline in quality of life related parameters of ZL-1310 with IO compared to chemo with IO using EORTC-QLQ-LC13
Time frame: up to approximately 3 years
Changes from baseline in quality of life parameters of ZL-1310 with IO compared to chemo with IO using EORTC-QLQ-C30
Time frame: up to approximately 3 years