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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| To assess the effectiveness in real world of EGFR-TKI adjuvant therapy in resected NSCLC as measured by 5-year OS rate | 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 | from enrollment up to 5 years after treatment initiation |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the effectiveness in real world of EGFR-TKI adjuvant therapy in resected as measured by 2, 3, 4, 5-year DFS rate | 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 | from enrollment up to 5 years after treatment initiation |
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Inclusion Criteria:
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stage IB to III NSCLC who have received adjuvant EGFR-TKI therapy.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| AstraZeneca Clinical Study Information Center | Contact | 1-877-240-9479 | information.center@astrazeneca.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Recruiting | Guangzhou | China |
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| To assess the treatment duration and reason for discontinuation in real world of EGFR-TKI adjuvant therapy in resected NSCLC | 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. | 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 to next treatment (TTNT) for adjuvant EGFR-TKI class is defined as time from initiation of adjuvant EGFR-TKI to start date of the next alternative systemic anti-cancer therapy other than EGFR-TKI, add on anti-cancer therapy or death. The primary measure of interest is median TTNT. | 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 | Safety will be evaluated in terms of SAEs and AEs leading to death | from enrollment up to 5 years after treatment initiation |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |