Status:
COMPLETED
A Real-world Study of Adjuvant Therapy in Early Stage NSCLC With EGFR Mutation-Positive in China
Lead Sponsor:
The First Affiliated Hospital of Guangzhou Medical University
Conditions:
NSCLC, Stage I
NSCLC, Stage II
Eligibility:
All Genders
Brief Summary
This study is a prospective, national, multi-center, non-interventional study. The main purpose is to explore the initial adjuvant treatment pattern after radical resection for early-stage NSCLC patie...
Detailed Description
About 2,000 eNSCLC patients who received radical resection from about 50 research centers across the country will be included in this study, and will be followed up to 2 years after enrollment accordi...
Eligibility Criteria
Inclusion
- Informed consent signed;
- Newly confirmed EGFR Mutation-Positive NSCLC confirmed by histopathology except for cytology;
- Receiving or not receiving neoadjuvant treatment before surgery;
- Patients with stage I-III NSCLC undergo confirmed radical R0 resection;
Exclusion
- Patients who currently or have previously participated in any other anti-tumor clinical studies;
- Patients with NSCLC who have received any systemic anti-cancer therapy as the main treatment in the past. Cytotoxic therapy, targeted therapy (tyrosine kinase inhibitors or monoclonal antibodies) and immunotherapy included except for the use of neoadjuvant therapy;
- Patients who have received adjuvant therapy before enrollment.
- Patients with stage I-III NSCLC whose surgical resection cannot be confirmed.
- Patients assessed by the investigator as unfit for enrollment, such as neurological disorders or metabolic disorders, physical examination or laboratory examination suspected that the patient has a possible disease, or has contraindications to the use of study drugs, or has treatment-related complications High risk etc.
Key Trial Info
Start Date :
July 9 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 7 2025
Estimated Enrollment :
1490 Patients enrolled
Trial Details
Trial ID
NCT04830826
Start Date
July 9 2020
End Date
April 7 2025
Last Update
July 30 2025
Active Locations (51)
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1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100000
2
Beijing Chest Hospital，Capital Medical university
Beijing, Beijing Municipality, China, 100000
3
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100000
4
Peking University People'S Hospital
Beijing, Beijing Municipality, China, 100000