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.
Bio-Thera Solutions·Phase 3·ClinicalTrials.gov·drugNot yet recruiting
View on ClinicalTrials.gov →Study focus
- Disease/Condition
- Carcinoma, Non-Small-Cell Lung
- Drug/Device/Intervention
- BAT3306
- Study type
- Interventional
- Intervention type
- drug
Sponsor & location
- Primary sponsor
- Bio-Thera Solutions
Timeline & enrollment
- Phase
- Phase 3
- Start date
- Aug 15, 2024
- End date
- Oct 30, 2028
- Enrollment
- 676 participants
Primary outcome
clinical equivalence
Summary
To compare the pairwise PK similarities between BAT3306, EU-Keytruda, and US-Keytruda, all
 administered with pemetrexed and carboplatin.
ICD-10 classifications
Carcinoma in situ: Bronchus and lungSecondary malignant neoplasm of lungMalignant neoplasm: Lower lobe, bronchus or lungMalignant neoplasm: Bronchus or lung, unspecifiedMalignant neoplasm of bronchus and lung
Data source
- Registry
- ClinicalTrials.gov
- Trial ID
- NCT06280196
- Type
- Non-Device Trial
About this record
Access comprehensive clinical trial information for NCT06280196 through Pure Global AI's free database. This Phase 3 trial is sponsored by Bio-Thera Solutions and is currently Not yet recruiting. The study focuses on Carcinoma, Non-Small-Cell Lung. Target enrollment is 676 participants.
This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.