Trial Profile

A randomized, parallel, double-blind, double-dummy, multicenter phase III clinical trial of mahuatinib versus gefitinib as first-line treatment for advanced non-squamous non-small cell lung cancer with EGFR sensitive mutations

Status: Completed

Phase of Trial: Phase III

Latest Information Update: 27 Nov 2025

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At a glance

24 Oct 2025 According to Huadong Medicine media release, the NMPA officially approved Malate Mefanertinib indicated as first-line treatment for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 21 L858R substitution mutation. Approval is based on the positive results from the Phase III HDHY-MHTN-III-1907 trial (CTR20192297).
08 Jul 2024 New trial record
04 Jun 2024 Primary endpoint (Progression-free survival (PFS) per independent review committee (IRC)) has been met.

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