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RECRUITING
NCT07180862
PHASE1

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

Sponsor: Bio-Thera Solutions

View on ClinicalTrials.gov

Summary

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

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

140

Start Date

2025-10-14

Completion Date

2027-11-30

Last Updated

2026-01-06

Healthy Volunteers

No

Interventions

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

Locations (1)

Union Hospital Tongji Medical College Huazhong University of Science & Technology

Wuhan, Hubei, China