Study identifier:D5161C00024
ClinicalTrials.gov identifier:NCT05546866
EudraCT identifier:N/A
CTIS identifier:N/A
An Open-label, Prospective, Multi-center, Single-arm Study to assess the efficacy and safety of Adjuvant Osimertinib in Non-small Cell Lung Cancer (NSCLC) with Uncommon Epidermal Growth Factor Receptor Mutations (EGFRm)
Non-small Cell Lung Cancer
Phase 2
No
Osimertinib
All
50
Interventional
18 Years - 130 Years
Allocation: N/A
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Jul 2024 by AstraZeneca
AstraZeneca
-
This is an open-label, multi-centre, single-arm study assessing the efficacy and safety of osimertinib as adjuvant treatment in stage IB-IIIB (8th AJCC) NSCLC with uncommon EGFRm after receiving complete surgical resection with or without adjuvant chemotherapy.
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Osimertinib Subjects successfully enrolled into the study will receive 80mg osimertinib QD p.o. until completion of planned treatment duration, recurrence of disease, or other treatment discontinuation criteria is met. The maximum treatment duration period is 3 years. | - |