NCT06280196

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

A Phase I/III, Multi-center, Randomized, Double-blind Study of BAT3306 Plus Chemotherapy Versus Keytruda® Plus Chemotherapy to Evaluate Pharmacokinetics, Efficacy, and Safety in Participants With Stage IV Non-squamous Non-small Cell Lung Cancer.

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 162 (actual)
• Sponsor: Bio-Thera Solutions · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To compare the pairwise PK similarities between BAT3306, EU-Keytruda, and US-Keytruda, all administered with pemetrexed and carboplatin.

Detailed description

This is a multi-center, double-blind, randomized study that includes PK and clinical equivalence comparisons, aimed at comparing BAT3306 with Keytruda® in previously untreated participants with Stage IV nsNSCLC.

Conditions

• Carcinoma, Non-Small-Cell Lung

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-07-19
• Primary completion: 2025-07-30
• Completion: 2025-07-30
• First posted: 2024-02-28
• Last updated: 2025-12-02

Locations

1 site across 1 country: China