Lung Cancer
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
AstraZeneca
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess the effectiveness in real world of EGFR-TKI adjuvant therapy in resected NSCLC as measured by 5-year OS rate | from enrollment up to 5 years after treatment initiation | 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
| Measure | Time frame | Description |
|---|---|---|
| To assess the effectiveness in real world of EGFR-TKI adjuvant therapy in resected as measured by 2, 3, 4, 5-year DFS rate | from enrollment up to 5 years after treatment initiation | 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 |
| To assess the treatment duration and reason for discontinuation in real world of EGFR-TKI adjuvant therapy in resected NSCLC | from enrollment up to 5 years after treatment initiation | Time to treatment discontinuation (TTD) of adjuvant EGFR-TKI is defined as the time from initiation of adjuvant EGFR-TKI to the earlier of the date of adjuvant therapy discontinuation or death. The primary measure of interest is median TTD. Reason for discontinuation would be collected. |
| To assess the safety of EGFR-TKI used as an adjuvant， neoadjuvant therapy and used for post recurrence in resected NSCLC | from enrollment up to 5 years after treatment initiation | Safety will be evaluated in terms of SAEs and AEs leading to death |
Countries
China
Contacts
CONTACTAstraZeneca Clinical Study Information Center
Outcome results
None listed