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Due to strategic decision, AZ has applied to terminate study at all participating sites and has committed that the data generated during the course of the study will not be submitted to China National Medical Products Administration.
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The primary objective is to describe the genomic profile of long-term survivors, especially to find out potential genomic prognosis and/or predictive factors for gefitinib long-term efficacy as compared to rapid PD patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Long-term survivors group (case) | EGFR M+ aNSCLC patients who continuously received gefitinib for at least 3 years | ||
| Rapid PD group (control) | EGFR M+ aNSCLC patients who had undergone PD after gefitinib treatment≤3 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with specific genomic alterations(mutation, copy number change and fusion) of short or long-term survivors | at time of sample collection before Gefitinib treatment initiation, up to 10 years before study start |
| Measure | Description | Time Frame |
|---|---|---|
| Sex | at time of Gefitinib treatment initiation,up to 10 years before study start | |
| Age | at time of Gefitinib treatment initiation, up to 10 years before study start | |
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Inclusion Criteria:
For inclusion in the long-term survivors group, the study subjects must fulfil the following criteria at the time of screening:
For inclusion in the rapid PD group, the study subjects must fulfil the following criteria:
Exclusion Criteria:
For the active patients, who must not enter the study if any of the following exclusion criteria are fulfilled 1. Patients who disagree to participate this study.
For the terminated patients, who must not enter the study if any of the following exclusion criteria are fulfilled
1. Patients in whose medical objection was recorded to use the existing data from medical practice for scientific research.
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This study will recruit approximately 150 aNSCLC patients who fulfil the inclusion/exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Yilong WU, Professor | Guangdong Provincial People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Beijing | Beijing Municipality | China | |||
| Research Site |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| Pre-existing comorbidities at initiation of gefitinib therapy |
| at time of Gefitinib treatment initiation, up to 10 years before study start |
| Cancer type and date of first ever cancer diagnosis | at time of Gefitinib treatment initiation, up to 10 years before study start |
| Histological subtype | at time of Gefitinib treatment initiation, up to 10 years before study start |
| Location(s) of metastatic disease at initiation of gefitinib therapy for subjects with TNM stage IV disease | at time of Gefitinib treatment initiation, up to 10 years before study start |
| EGFR mutation status | at time of Gefitinib treatment initiation, up to 10 years before study start |
| Smoking status | at time of Gefitinib treatment initiation, up to 10 years before study start |
| ECOG performance status at time of Gefitinib treatment initiation | at time of Gefitinib treatment initiation, up to 10 years before study start |
| Gefitinib treatment patterns- Starting dose | at time of Gefitinib treatment initiation, up to 10 years before study start |
| Gefitinib treatment patterns- Dose reductions, treatment interruptions, discontinuation including reasons | from Gefitinib treatment initiation to Gefitinib treatment discontinuation or study completion, whichever occurred first, up to 12 years |
| Gefitinib treatment patterns- Types of other systemic therapies given in combination with gefitinib | from Gefitinib treatment initiation to Gefitinib treatment discontinuation or study completion, whichever occurred first, up to 12 years |
| Therapeutic agent name post-gefitinib discontinuation | from gefitinib discontinuation to one year post- gefitinib discontinuation, around one year |
| Documented tumour response (complete or partial response or stable disease, according to RECIST) as determined by the treating physician by clinical judgment and/or imaging after first ever initiation of gefitinib | from Gefitinib treatment initiation to study completion, up to 12 years |
| Progression Free Survival (PFS) | from Gefitinib treatment initiation to disease progression or study completion, whichever occurred first, up to 12 years |
| Overval survival (OS) | from Gefitinib treatment initiation to death or study completion, whichever occurred first, up to 12 years |
| Fuzhou |
| Fujian |
| China |
| Research Site | Guangzhou | Guangdong | China |
| Research Site | Shijiazhuang | Hebei | China |
| Research Site | Zhengzhou | Henan | China |
| Research Site | Wuhan | Hubei | China |
| Research Site | Nanjing | Jiangsu | China |
| Research Site | Changchun | Jilin | China |
| Research Site | Shenyang | Liaoning | China |
| Research Site | Xi'an | Shaanxi | China |
| Research Site | Shanghai | Shanghai Municipality | China |
| Research Site | Taiyuan | Shanxi | China |
| Research Site | Chengdu | Sichuan | China |
| Research Site | Hangzhou | Zhejiang | China |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |