Trials / Completed
CompletedNCT04830826
A Real-world Study of Adjuvant Therapy in Early Stage NSCLC With EGFR Mutation-Positive in China
A Prospective, National, Multi-center, Non-intervention Real-world Study of Adjuvant Therapy in Early Stage NSCLC With EGFR Mutation-Positive in China
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,490 (actual)
- Sponsor
- The First Affiliated Hospital of Guangzhou Medical University · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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 patients with EGFR Mutation-Positive in the real world. The secondary purpose was to observe the postoperative follow-up treatment pattern and its subgroups (based on different EGFR mutation status and different clinical stages).
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 according to the actual clinical situation. The analysis method of this study is mainly based on descriptive statistics. The information about the human genetic resources of the subjects to be collected includes: demography, physical examination, WHO fitness status, medical history, smoking history, disease characteristics, surgical information, initial and follow-up adjuvant treatment pattern, laboratory tests, survival status, and adverse events related to gefitinib/osimertinib, serious adverse events/non-severe ADR, measures taken for adverse events, outcome of adverse events.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Surgeries | Surgeries |
Timeline
- Start date
- 2020-07-09
- Primary completion
- 2024-07-08
- Completion
- 2025-04-07
- First posted
- 2021-04-05
- Last updated
- 2025-07-30
Locations
51 sites across 1 country: China
Source: ClinicalTrials.gov record NCT04830826. Inclusion in this directory is not an endorsement.