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A Study to Evaluate PK, Efficacy, and Safety of BAT3306 Plus Chemo and Compare With Keytruda®(EU/US) in Participants With IV nqNSCLC - Trial NCT06280196

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.

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NCT06280196
Phase 3
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov • NCT06280196
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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.

Study Focus

BAT3306

Interventional

drug

Sponsor & Location

Bio-Thera Solutions

Timeline & Enrollment

Phase 3

Aug 15, 2024

Oct 30, 2028

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 lung
Secondary malignant neoplasm of lung
Malignant neoplasm: Lower lobe, bronchus or lung
Malignant neoplasm: Bronchus or lung, unspecified
Malignant neoplasm of bronchus and lung

Data Source

ClinicalTrials.gov

NCT06280196

Non-Device Trial