NCT07180862

A Study Evaluating BAT3306 Compared With Keytruda® in NSCLC Cancer Participants

A Phase 1, Randomized, Double-blind Study to Compare the Pharmacokinetics, Between BAT3306 and Keytruda® (Pembrolizumab) in Participants With Stage IB-IIIA Non-small Cell Lung Cancer Following Complete Resection

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Bio-Thera Solutions · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Comparing the PK similarity of BAT3306 and Keytruda; in NSCLC participants who were completely removed by surgery as an auxiliary treatment

Detailed description

This is a multicenter, randomized, double-blind, parallel-controlled, Phase 1 clinical study to evaluate the PK similarity of BAT3306 versus Keytruda® as adjuvant therapy in participants with early stage NSCLC. Participants must have no EGFR gene mutation or ALK gene rearrangement, have not received neoadjuvant or adjuvant radiotherapy and/or neoadjuvant chemotherapy, and have no plans for such treatment. A total of approximately 140 eligible participants will be randomly assigned in a 1:1 ratio to 2 double-blind treatment groups. Participants who meet all inclusion criteria and none of exclusion criteria will be randomized in an Interactive Web Response System (IWRS). All participants will receive the investigational medicinal product at 200 mg via intravenous infusion every 3 weeks for a treatment period of up to 12 months . Serum samples will be collected from participants at specified time points for PK analysis to evaluate the PK similarity and PK characteristics of BAT3306 versus Keytruda®, while also assessing their immunogenicity and safety, and preliminarily comparing their improvement in disease-free survival (DFS).

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	US-Keytruda®	One vial of 4 mL of concentrate contains 100 mg of pembrolizumab

Timeline

• Start date: 2025-10-14
• Primary completion: 2027-02-28
• Completion: 2027-11-30
• First posted: 2025-09-18
• Last updated: 2026-01-06

Locations

1 site across 1 country: China