Real-World Outcomes of Resected EGFR-Mutated NSCLC Patients Treated With Adjuvant EGFR-TKI in China
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Lung Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
This is a multi-centre, observational study, with retrospective data collection and prospective active follow-up. The study will enroll adult patients from China with resected, stage IB to III NSCLC who have received adjuvant EGFR-TKI therapy. Approximately 2,000 patients will be enrolled from 15 sites in China.
Patients will be followed up from the index date to the earliest of death, loss to follow-up, or the end of study. Data accumulated before informed consent will be collected retrospectively. For prospective data collection, every 12-week data collection frequency will be performed for the first 1-year from index date; and every 24-week data collection frequency will be performed afterward until the end of follow-up. All study-relevant data occurring during the follow-up period will be captured irrespective of planned follow-up frequency, with collection conducted via medical record abstraction and/or telephone interviews.
Primary outcome measures
- To assess the effectiveness in real world of EGFR-TKI adjuvant therapy in resected NSCLC as measured by 5-year OS rate [Time frame: from enrollment up to 5 years after treatment initiation]
Secondary outcome measures (4)
- To assess the effectiveness in real world of EGFR-TKI adjuvant therapy in resected as measured by 2, 3, 4, 5-year DFS rate [Time frame: from enrollment up to 5 years after treatment initiation]
- To assess the treatment duration and reason for discontinuation in real world of EGFR-TKI adjuvant therapy in resected NSCLC [Time frame: from enrollment up to 5 years after treatment initiation]
- To assess the treatment duration and reason for discontinuation in real world of EGFR-TKI adjuvant therapy in resected NSCLC [Time frame: from enrollment up to 5 years after treatment initiation]
- To assess the safety of EGFR-TKI used as an adjuvant， neoadjuvant therapy and used for post recurrence in resected NSCLC [Time frame: from enrollment up to 5 years after treatment initiation]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
China · 1 center
- Research Site — Guangzhou
Identifiers
NCT: NCT07593248 · D5164R00012