A Study of Carboplatin Plus Etoposide With or Without ZKAB001 (Anti-PD-L1 Antibody) in Patients With ES-SCLC

PHASE3CompletedINTERVENTIONAL
Enrollment

498

Participants

Timeline

Start Date

July 15, 2021

Primary Completion Date

October 13, 2023

Study Completion Date

October 13, 2023

Conditions
Extensive-stage Small-cell Lung Cancer
Interventions
BIOLOGICAL

ZKAB001

Patients will receive ZKAB001 5mg/kg administered by IV infusion every 21days,

DRUG

Placebo

Patients will receive placebo administered by IV infusion every 21days.

DRUG

Carboplatin

Carboplatin should be administered after completion of placebo/ZKAB001 by IV infusion over 30-60 minutes to achieve an initial target AUC of 5 mg/mL/min. Carboplatin and etoposide will be used for a total of 4 cycles, followed by placebo/ZKAB001 maintenance therapy.

DRUG

Etoposide

"Etoposide (100 mg/m\^2) should be administered intravenously over 60 minutes following carboplatin administration. On Days 2 and 3 of each cycle, etoposide 100 mg/m2) should be administered intravenously over 60 minutes.~Carboplatin and etoposide will be used for a total of 4 cycles, followed by placebo/ZKAB001 maintenance therapy."

Trial Locations (1)

021

Shanghai Chest Hospital, Shanghai

Sponsors
All Listed Sponsors
lead

Lee's Pharmaceutical Limited

INDUSTRY