Status:
UNKNOWN
First Line Osimertinib for EGFR Mutation-positive Non-Small Cell Lung Cancer in Real World Chinese Setting
Lead Sponsor:
First Affiliated Hospital of Zhejiang University
Collaborating Sponsors:
AstraZeneca
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
18+ years
Brief Summary
The results of phase III FLAURA study showed a significant PFS benefit for first-line Osimertinib versus standard EGFR-TKIs in patients with EGFR mutation-positive NSCLC, the median PFS was 18.9 month...
Detailed Description
Total of \~30 study sites are selected for conducting this observational study. Eligible patients will be prospectively and consecutively included. Therefore, the clinical practice in the selected pat...
Eligibility Criteria
Inclusion
- Ability to provide informed consent, complete all study assessments and have complete medical record;
- Histologically or cytologically documented locally advanced, metastatic NSCLC, which are not amenable to curative surgery or radiotherapy;
- With confirmation of the presence of the EGFR mutation.
- Patients must be treatment- naïve for locally advanced or metastatic NSCLC.
- Age ≥ 18 years
- Patients who plan to receive Osimertinib monotherapy as the initial first line treatment based on physician's medical judgement.
Exclusion
- Patients who will be or were involved in any other interventional anti-tumour clinical studies for locally advanced/metastatic NSCLC currently or previously
- Any concomitant condition evaluated by physicians which is not suitable for Osimertinib treatment.
- Patients who have received the first dose of Osimertinib before the signature of ICF won't be allowed to enroll in.
Key Trial Info
Start Date :
July 27 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2024
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT04391283
Start Date
July 27 2020
End Date
December 1 2024
Last Update
March 17 2023
Active Locations (1)
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1
The First Affiliated Hospital of College of Medicine Zhejiang University
Hangzhou, Zhejiang, China, 310000