A Study to Evaluate PK, Efficacy, and Safety of BAT3306 Plus Chemo and Compare With Keytruda®(EU/US) in Participants With IV nqNSCLC

PHASE3TerminatedINTERVENTIONAL
Enrollment

162

Participants

Timeline

Start Date

July 19, 2024

Primary Completion Date

July 30, 2025

Study Completion Date

July 30, 2025

Conditions
Carcinoma, Non-Small-Cell Lung
Interventions
DRUG

BAT3306

One vial of 4 mL of concentrate contains 100 mg of BAT3306

DRUG

EU-Keytruda®

One vial of 4 mL of concentrate contains 100 mg of pembrolizumab

DRUG

US-Keytruda®

One vial of 4 mL of concentrate contains 100 mg of pembrolizumab

DRUG

Pemetrexed

500 mg/m2 on Day 1 of each 21-day cycle of the study

DRUG

Carboplatin

Target AUC of 5 mg/mL/min on Day 1 of each 21-day cycle up to 4 cycles

Trial Locations (1)

Unknown

Union Hospital Tongji Medical College Huazhong University of Science & Technology, Wuhan

Sponsors
All Listed Sponsors
lead

Bio-Thera Solutions

INDUSTRY