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AZD9291 Early Access Program (EAP) was available in Taiwan during October 2015 to September 2016, a time period before the approval of AZD9291, to supply the unlicensed AZD9291 for the NSCLC patients who received at least one prior EGFR TKI therapy. At the end of September 2016, more than 450 patients have been under AZD9291 treatment through the EAP. This observational study aims to evaluate the clinical benefit of AZD9291 treatment for these patients who were in the EAP
AZD9291 Early Access Program (EAP) was available in Taiwan during October 2015 to September 2016, a time period before the approval of AZD9291, to supply the unlicensed AZD9291 for the NSCLC patients who received at least one prior EGFR TKI therapy. At the end of September 2016, more than 450 patients have been under AZD9291 treatment through the EAP. This observational study aims to evaluate the clinical benefit of AZD9291 treatment for these patients who were in the EAP
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| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival (PFS) | PFS is defined as the time interval (in months) from the first dose of AZD9291 in the EAP to the date of disease progression | Every 12 weeks until treatment discontinuation as defined by RECIST 1.1 projected 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | OS is defined as the time interval (in months) from the date of the first dose of AZD9291 in the EAP until the date of death due to any cause | Every 12 weeks until treatment discontinuation as defined by RECIST 1.1 projected 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate (RR) | RR is defined as the percentage of subjects with the best overall response of 'responding', which is defined as complete response (CR) or partial response (PR), by investigator's assessment | Every 12 weeks until treatment discontinuation as defined by RECIST 1.1 projected 12 months |
| Disease Control Rate (DCR) |
Inclusion Criteria:
Exclusion Criteria:
• Patients who did not receive at least one dose of EGFR TKI for the treatment of EGFR mutation (+) NSCLC
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All the available patients who have participated in the AZD9291 EAP will be screened for the eligible criteria for data collection in this observational study
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Kaohsiung City | 807 | Taiwan | |||
| Research Site |
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| Label | URL |
|---|---|
| CSR\_Synopsis | View source |
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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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DCR is defined as the percentages of subjects who have the best overall response of CR, PR, or SD, which is determined by investigator's assessment. |
| Every 12 weeks until treatment discontinuation as defined by RECIST 1.1 projected 12 months |
| Time to treatment discontinuation (TTD) | TTD is defined as the time interval (in months) from the date of the first dose of AZD9291 in the EAP until the date of the single use of AZD9291 discontinuation for any reason | Time from patient first dose to data cut off (up to 32 months) |
| Kaohsiung City |
| 83301 |
| Taiwan |
| Research Site | Taichung | 40705 | Taiwan |
| Research Site | Tainan | 70403 | Taiwan |
| Research Site | Tainan | 73657 | Taiwan |
| Research Site | Taipei | 10002 | Taiwan |
| Research Site | Taipei | 112 | Taiwan |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |