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third generation of EGFR-TKIs is the newest target therapy for NSCLC. However, we did not known the specific mechanisms for those non-responders and patients grow resistance.Next generation sequencing is current the most sensitive and specific method to exam gene mutation, diversion etc.
By consistently detect the cf-DNA, we could possibly find out the mechanisms of response and resistance.
Study backgroud: third generation of epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) is the newest target therapy for non small cell lung cancer (NSCLC). Two major study published in NEJM show that the overall response rate is about 60%-70%, with a progression free survival about 10 months. However, we did not known the specific mechanisms for those non-responders and patients grow resistance.
Next generation sequencing is current the most sensitive and specific method to exam gene mutation, diversion etc. By consistently detect the cf-DNA, we could possibly find out the mechanisms of response and resistance.
Eligible patients received 3rd generation EGFR-TKIs (AZD9291 and AVITINIB) were enrolled into this study. Tumor tissue sample within 6 months, and 10ml periphereal blood samples were collected at baseline. After treatment initiation, 10ml periphereal blood would be collected at every image testing time point until disease progression. Blood samples will be draw using EDTA tube and centerfuged within 2 hours and store in -80 refrigerator.
NGS testing will cover target genes of NSCLC.
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| Measure | Description | Time Frame |
|---|---|---|
| cf-DNA change from baseline | Using next generation sequencing (NGS) method to detect circulating free DNA (cf-DNA) in patients receive third generation EGFR-TKI, periphereal blood sample were collected at baseline and every 2 months to disease progression. | baseline and every 2 months up to 36 months or first documented progression disease. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with advanced non-small cell lung cancer (NSCLC),prepare to receive third generation of epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) treatment. Patients must harboured with positive EGFR mutation (19 exon deletion, L858RăG719XăL861Q mutation), able to provide periphereal blood and tumor tissue.
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| Name | Affiliation | Role |
|---|---|---|
| Li Zhang | Sun Yat-Sen University Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-Sen University Cancer Center | Guangzhou | Guangdong | 510030 | China | ||
| Sun Yat-sen University Cancer Center |
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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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periphereal blood 10ml,centrifuge:4âă2400gă10min,extracted plasma and stored in -80° refrigerator.
fresh tumor tissue sample,store in freezing medium within 2 hours. FFPE tumor tissue.
| Guangzhou |
| Guangdong |
| 510060 |
| China |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |