Adjuvant Therapy of Ensartinib in Stage IB-IIIA ALK-positive Non-small Cell Lung Cancer

This is a prospective, multi-center, single-arm, phase 2 study aiming to assess the efficacy and safety of adjuvant use of Ensartinib in stage IB-IIIA non-small cell lung cancer (NSCLC) with positive ALK-fusion. Enrolled patients will take Ensatinib for 3 years or until recurrence of the disease or intolerable toxicity, following complete tumour resection with or without adjuvant standard chemotherapy.

Trial Details

NCT ID
NCT05241028
Phase
PHASE2
Sponsor
Hebei Medical University Fourth Hospital
Status
RECRUITING
Cancer Type
Lung Cancer
Interventions
  • Ensartinib
Locations (sample)
  • Shijiazhuang, Hebei, China|38.04139,114.47861

Key Eligibility Criteria

  • Completely resected pathological stage IB-IIIA NSCLC with ALK-fusion positive (confirmed by FISH, IHC or NGS).
  • Males or females aged ≥18 years, ≤75 years.
  • ECOG performance status 0-2.
  • Completely recovered from surgery or standard postoperative chemotherapy before receiving adjuvant ensatinib treatment. (When starting the study tr…

For full eligibility, visit ClinicalTrials.gov.

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