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To evaluate the molecular testing pattern in metastatic NSCLC patients after QIP; To evaluate the treatment pattern in metastatic NSCLC patients after QIP.
The primary objective of this study is to assess the implementation of standardized diagnosis and treatment practice in oncology departments of Small/Middle tier cities and County hospitals, after standardized education and implementation of lung cancer clinical practice guidelines for oncology physicians.
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| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the molecular testing pattern in metastatic NSCLC patients after QIP | Molecular testing-rate for the first-line treatment: Defined as the number of participants received molecular testing for the first-line treatment divided by total participants. | Approximately 1 month after last patient in |
| To evaluate the treatment pattern in metastatic NSCLC patients after QIP | TKIs first-line treatment rate: Defined as TKIs first-line treatment rate in AGA positive participants. | Approximately 1 month after last patient in |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the clinical outcomes in metastatic NSCLC patients after QIP | Progression Free Survival (PFS): Defined as the time from beginning of first-line treatment to disease progression or death for any cause, whichever occurs first. | Follow up approximately 24 months after last patient in |
| To evaluate the treatment pattern in metastatic NSCLC patients after QIP |
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Inclusion Criteria:
Exclusion Criteria:
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Patients newly pathologic diagnosed metastatic NSCLC (clinical stage IV) or recurrent metastatic NSCLC will be enrolled.
Approximately 1000 patients will be enrolled from about 50 sites in China.
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| Name | Affiliation | Role |
|---|---|---|
| Yilong WU | Guangdong Provincial People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Anning | China | ||||
| Research Site |
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.
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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1st/2nd/3rd generation EGFR-TKIs first-line treatment rate: Defined 1st/2nd/3rd generation EGFR-TKIs first-line treatment rate in EGFR positive participants. |
| Approximately 1 month after last patient in |
| To evaluate the treatment pattern in metastatic NSCLC patients after QIP | Immunotherapy first-line treatment rate: Defined as PD-1 or PD-L1 inhibitors first-line treatment rate in AGA negative participants. | Approximately 1 month after last patient in |
| To evaluate the clinical outcomes in metastatic NSCLC patients after QIP | Response rate: Defined as the percentage of participants with the disease first-line treatment response by investigator assessment as recorded in CRF. | Follow up approximately 24 months after last patient in |
| To evaluate the clinical outcomes in metastatic NSCLC patients after QIP | Disease control rate: Defined as the percentage of participants with the disease first-line treatment control by investigator assessment as recorded in CRF | Follow up approximately 24 months after last patient in |
| To evaluate the clinical outcomes in metastatic NSCLC patients after QIP | Duration of Response: Defined as the time from first-line treatment response to disease progression or death in participants who achieve responding by investigator assessment as recorded in CRF. | Follow up approximately 24 months after last patient in |
| Anqing |
| China |
| Research Site | Changzhi | China |
| Research Site | Daqing | China |
| Research Site | Dazhou | China |
| Research Site | Dazhu | China |
| Research Site | Dingzhou | China |
| Research Site | Ganzhou | China |
| Research Site | Guangzhou | China |
| Research Site | Guang’an | China |
| Research Site | Hanzhong | China |
| Research Site | Hebi | China |
| Research Site | Hengyang | China |
| Research Site | Huaibei | China |
| Research Site | Jining | China |
| Research Site | Jinzhou | China |
| Research Site | Liyang | China |
| Research Site | Lu'an | China |
| Research Site | Meihekou | China |
| Research Site | Nanchong | China |
| Research Site | Nanyang | China |
| Research Site | Ningde | China |
| Research Site | Ningxiang | China |
| Research Site | Panjin | China |
| Research Site | Pingxiang | China |
| Research Site | Quanzhou | China |
| Research Site | Shengzhou | China |
| Research Site | Suzhou | China |
| Research Site | Taizhou | China |
| Research Site | Tancheng | China |
| Research Site | Tongling | China |
| Research Site | Wafangdian | China |
| Research Site | Weifang | China |
| Research Site | Wuzhou | China |
| Research Site | Xiangtan | China |
| Research Site | Xianning | China |
| Research Site | Xiantao | China |
| Research Site | Xixian | China |
| Research Site | Xuzhou | China |
| Research Site | Yangjiang | China |
| Research Site | Yangzhou | China |
| Research Site | Yibin | China |
| Research Site | Yichun | China |
| Research Site | Yingkou | China |
| Research Site | Zhangjiakou | China |
| Research Site | Zhuji | China |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
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