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A randomized, multi-center, Phase 3 trial will assess the efficacy, safety, pharmacokinetics, and immunogenicity of Envafolimab in patients with resectable Stage IIIA and IIIB (N2) NSCLC

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Trial Profile

A randomized, multi-center, Phase 3 trial will assess the efficacy, safety, pharmacokinetics, and immunogenicity of Envafolimab in patients with resectable Stage IIIA and IIIB (N2) NSCLC

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 29 Oct 2025

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At a glance

  • Drugs Envafolimab (Primary)
  • Indications Non-small cell lung cancer
  • Focus Adverse reactions; Pharmacodynamics; Pharmacokinetics; Registrational; Therapeutic Use

Most Recent Events

  • 29 Oct 2025 New trial record
  • 05 Sep 2025 According to a Glenmark Pharmaceuticals media release, In parallel, Glenmark has submitted a Clinical Trial Application (CTA) in Russia and is preparing to open additional clinical trial sites in Brazil and Mexico, further expanding the global footprint of this pivotal study.
  • 05 Sep 2025 According to a Glenmark Pharmaceuticals media release, the Drugs Controller General of India (DCGI) has granted a No Objection Certificate allowing the company to commence patient enrollment and dosing in India. Clinical trial applications are also underway in Russia, Brazil and Mexico, enabling the multi country Phase 3 trial of Envafolimab to progress in these regions.

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