MedTrace Logo

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

NCT06280196 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2025-12-02

No results posted yet for this study

Summary

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

Conditions

  • Carcinoma, Non-Small-Cell Lung

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Xiaorong Dong, Dr. · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-19
Primary Completion
2025-07-30
Completion
2025-07-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06280196 on ClinicalTrials.gov