Clinical trial · Observational
Real-World Outcomes of Resected EGFR-Mutated NSCLC Patients Treated With Adjuvant EGFR-TKI in China
NCT07593248CI-TRIAL-00121957ECHOrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a multi-centre, observational study, with retrospective data collection and prospective active follow-up. The aim is to measure the treatment pattern and real-world outcomes of EGFR-TKI as an adjuvant therapy in patients with early-stage EGFR-mutated NSCLC. The study period ranges from July 1st, 2022 to June 30th, 2031. Approximately 2,000 patients will be enrolled from 15 sites in China.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To assess the effectiveness in real world of EGFR-TKI adjuvant therapy in resected NSCLC as measured by 5-year OS rate
- timeFrame
- from enrollment up to 5 years after treatment initiation
- description
- OS is defined as the time from the first dose of EGFR-TKI adjuvant therapy until the date of death due to any cause. The analysis will include all patients received EGFR-TKI adjuvant therapy during the study. All deaths will be included, regardless of whether the patient withdraws from therapy or receives another anti-cancer therapy. The primary measure of interest is the OS rate at 5 years
Secondary outcomes (4)
- measure
- To assess the effectiveness in real world of EGFR-TKI adjuvant therapy in resected as measured by 2, 3, 4, 5-year DFS rate
- timeFrame
- from enrollment up to 5 years after treatment initiation
- description
- Real-world DFS landmark rwDFS is defined as from date of first adjuvant EGFR-TKI to first documented recurrence or death. Patient without known recurrence or death would be censored at the last date of follow-up. DFS rate at 2, 3, 4 and 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosed stage IB-III NSCLC on or prior to the index date; * Initiated adjuvant EGFR-TKI from July 1st, 2023 to June 30th, 2026
References
Publications (0)
Data not yet available
No reference posted for this study.