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

Sponsor
Bio-Thera Solutions
Study ID
NCT06280196
Phase
PHASE3
Status
Terminated

Conditions

  • Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BAT3306 — DRUG
    One vial of 4 mL of concentrate contains 100 mg of BAT3306
  • EU-Keytruda® — DRUG
    One vial of 4 mL of concentrate contains 100 mg of pembrolizumab
  • US-Keytruda® — DRUG
    One vial of 4 mL of concentrate contains 100 mg of pembrolizumab
  • Pemetrexed — DRUG
    500 mg/m2 on Day 1 of each 21-day cycle of the study
  • Carboplatin — DRUG
    Target AUC of 5 mg/mL/min on Day 1 of each 21-day cycle up to 4 cycles

Study Details

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

Key Dates

Start date
Jul 19, 2024
Status verified
Dec 2025
Primary completion
Jul 30, 2025
Completion
Jul 30, 2025

Study Design

Enrollment
162 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: BAT3306
    25 mg/mL concentrate for solution for infusion.200 mg on Day 1 of each 21-day cycle
  • Active Comparator: EU-Keytruda® arm
    25 mg/mL concentrate for solution for infusion.200 mg on Day 1 of each 21-day cycle
  • Active Comparator: US-Keytruda® arm
    25 mg/mL concentrate for solution for infusion. 200 mg on Day 1 of each 21-day cycle

Primary Outcome Measure

clinical equivalence [ Time Frame: Week 3,5,7,9,12,15,EOT ]

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