Trial Profile

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.

Status: Discontinued

Phase of Trial: Phase III

Latest Information Update: 09 Jun 2026

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At a glance

Drugs Carboplatin (Primary) ; Pembrolizumab (Primary) ; Pemetrexed (Primary)
Indications Non-small cell lung cancer
Focus Pharmacokinetics; Registrational
Sponsors Bio-Thera Solutions

25 Jul 2024 According to a Bio-Thera Solutions media release, the company announced that dosing has recently begun in an integrated Phase I / Phase III clinical study for BAT3306, a proposed biosimilar of Keytruda (pembrolizumab).
25 Jul 2024 Status changed from not yet recruiting to recruiting, according to a Bio-Thera Solutions media release.
01 Mar 2024 New trial record

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