498
Participants
Start Date
July 15, 2021
Primary Completion Date
October 13, 2023
Study Completion Date
October 13, 2023
ZKAB001
Patients will receive ZKAB001 5mg/kg administered by IV infusion every 21days,
Placebo
Patients will receive placebo administered by IV infusion every 21days.
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.
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."
Shanghai Chest Hospital, Shanghai
Lead Sponsor
Lee's Pharmaceutical Limited
INDUSTRY