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A Phase III Double-blind, Randomized, Placebo-Controlled Multi-centre Study to Assess the Efficacy and Safety of Ensartinib Versus Placebo as Adjuvant Therapy in Patients With Anaplastic Lymphoma Kinase (ALK)-Positive Stage II - IIIB Non-small Cell Lung Cancer, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy.

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Trial Profile

A Phase III Double-blind, Randomized, Placebo-Controlled Multi-centre Study to Assess the Efficacy and Safety of Ensartinib Versus Placebo as Adjuvant Therapy in Patients With Anaplastic Lymphoma Kinase (ALK)-Positive Stage II - IIIB Non-small Cell Lung Cancer, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy.

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 30 Sep 2026

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At a glance

  • Drugs Ensartinib (Primary)
  • Indications Carcinoma; Non-small cell lung cancer
  • Focus Therapeutic Use
  • Acronyms ELEVATE
  • Sponsors Betta Pharmaceuticals Co Ltd

Most Recent Events

  • 14 Sep 2026 According to Betta Pharmaceuticals media release, based on the results from the trial, The China's National Medical Products Administration (NMPA) approved ensartinib hydrochloride for adjuvant treatment following surgical resection in patients with ALK-positive stage IB-IIIB non-small cell lung cancer (NSCLC), with or without adjuvant chemotherapy as determined by the treating physician.
  • 14 Sep 2026 Results presented in the Betta Pharmaceuticals media release.
  • 13 Jul 2022 Status changed from not yet recruiting to recruiting.

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