To describe the T790M mutation status of patients with locally advanced/metastatic NSCLC who progressed on previous EGFR TKI treatment in a real-world setting.
Name: Plasma-tissue testing
Description: Based on the plasma-tissue testing algorithm in NSCLC patients who progressed on previous EGFR TKI therapy
Measure: EGFR T790M mutation prevalance Time: 3 yearsDescription: Proportion of study subjects who have a valid tissue/cytology T790M testing result after receiving a negative plasma test result for the T790M mutation
Measure: Proportion of Valid Tissue T790M Testing Result Time: 3 yearsDescription: Proportions of study subjects who are T790M plasma-negative
Measure: T790M Plasma Outcome Time: 3 yearsDescription: Proportion of study subjects who are T790M plasma-negative but T790M tissue/cytology-positive
Measure: False Negative Proportation Time: 3 yearsDescription: reasons given for not performing re-biopsy and tissue/cytology testing after obtaining a negative plasma test result
Measure: Reasons for not performing re-biopsy Time: 3 yearsDescription: Demographics of T790M-positive subjects and T790M-negative subjects
Measure: Demographics Time: BaselineDescription: Disease characteristics of T790M-positive subjects and T790M-negative subjects
Measure: Disease Characteristics Time: 3 yearsDescription: Number of particapants with complications assoicated with tissue/cytology re-biopsy
Measure: Number of particapants with complications assoicated with re-biopsy Time: 3 yearsDescription: Clinical outcomes after osimertinib treatment between study subjects who are T790M plasma-positive
Measure: Clinical Outcomes in T790M plasma-positive subejects Time: 3 yearsDescription: Clinical outcomes after osimertinib treatment between study subjects who are urine-positive
Measure: Clinical Outcomes in urine-positive Time: 3 yearsDescription: Clinical outcomes after osimertinib treatment between study subjects who are tissue/cytology-positive
Measure: Clinical Outcomes in tissue/cytology-positive Time: 3 yearsDescription: To analyze the concordance of T790M mutation status as determined by urine, plasma, and tissue/cytology T790M testing
Measure: Concordance Time: 3 yearsCohort
There are 2 SNPs
Inclusion Criteria - Provision of written informed consent - Locally advanced (stage IIIB) or metastatic (stage IV) NSCLC, not amenable to curative surgery or radiotherapy - Confirmed EGFR sensitizing mutation (exon 19 deletion or exon 21 L858R ) in medical record - Progressed on previous EGFR TKI treatment, based on physician judgement, with or without additional lines of treatment - Suggested to undergo T790M mutation testing by treating physician, based on physician judgement Exclusion Criteria - Had been treated with osimertinib or any other 3rd generation T790M inhibitors - Enrollment in studies that prohibit participation in this observational study Inclusion Criteria - Provision of written informed consent - Locally advanced (stage IIIB) or metastatic (stage IV) NSCLC, not amenable to curative surgery or radiotherapy - Confirmed EGFR sensitizing mutation (exon 19 deletion or exon 21 L858R ) in medical record - Progressed on previous EGFR TKI treatment, based on physician judgement, with or without additional lines of treatment - Suggested to undergo T790M mutation testing by treating physician, based on physician judgement Exclusion Criteria - Had been treated with osimertinib or any other 3rd generation T790M inhibitors - Enrollment in studies that prohibit participation in this observational study Non-small Cell Lung Cancer Carcinoma, Non-Small-Cell Lung This is a multi-center, observational study of patients with locally advanced/metastatic NSCLC who progressed on previous EGFR TKI treatment. --- L858R ---
Inclusion Criteria - Provision of written informed consent - Locally advanced (stage IIIB) or metastatic (stage IV) NSCLC, not amenable to curative surgery or radiotherapy - Confirmed EGFR sensitizing mutation (exon 19 deletion or exon 21 L858R ) in medical record - Progressed on previous EGFR TKI treatment, based on physician judgement, with or without additional lines of treatment - Suggested to undergo T790M mutation testing by treating physician, based on physician judgement Exclusion Criteria - Had been treated with osimertinib or any other 3rd generation T790M inhibitors - Enrollment in studies that prohibit participation in this observational study Inclusion Criteria - Provision of written informed consent - Locally advanced (stage IIIB) or metastatic (stage IV) NSCLC, not amenable to curative surgery or radiotherapy - Confirmed EGFR sensitizing mutation (exon 19 deletion or exon 21 L858R ) in medical record - Progressed on previous EGFR TKI treatment, based on physician judgement, with or without additional lines of treatment - Suggested to undergo T790M mutation testing by treating physician, based on physician judgement Exclusion Criteria - Had been treated with osimertinib or any other 3rd generation T790M inhibitors - Enrollment in studies that prohibit participation in this observational study Non-small Cell Lung Cancer Carcinoma, Non-Small-Cell Lung This is a multi-center, observational study of patients with locally advanced/metastatic NSCLC who progressed on previous EGFR TKI treatment. --- L858R --- --- T790M --- --- T790M --- --- L858R ---
An Observational, Multi-centre Study on EGFR T790M Mutation Testing Practices and Outcomes Conducted Among Locally Advanced/Metastatic NSCLC Patients Who Progressed on Previous EGFR Tyrosine-kinase Inhibitor (TKI) Therapy in Hong Kong. --- T790M ---
Epidermal Growth Factor Receptor (EGFR) T790M Mutation Testing Practices in Hong Kong To describe the T790M mutation status of patients with locally advanced/metastatic NSCLC who progressed on previous EGFR TKI treatment in a real-world setting. --- T790M ---
Epidermal Growth Factor Receptor (EGFR) T790M Mutation Testing Practices in Hong Kong To describe the T790M mutation status of patients with locally advanced/metastatic NSCLC who progressed on previous EGFR TKI treatment in a real-world setting. --- T790M --- --- T790M ---
EGFR T790M mutation prevalance. --- T790M ---
Proportion of Valid Tissue T790M Testing Result. --- T790M ---
Proportion of study subjects who have a valid tissue/cytology T790M testing result after receiving a negative plasma test result for the T790M mutation. --- T790M ---
Proportion of study subjects who have a valid tissue/cytology T790M testing result after receiving a negative plasma test result for the T790M mutation. --- T790M --- --- T790M ---
T790M Plasma Outcome. --- T790M ---
Proportions of study subjects who are T790M plasma-negative. --- T790M ---
Proportion of study subjects who are T790M plasma-negative but T790M tissue/cytology-positive. --- T790M ---
Proportion of study subjects who are T790M plasma-negative but T790M tissue/cytology-positive. --- T790M --- --- T790M ---
Demographics of T790M-positive subjects and T790M-negative subjects. --- T790M ---
Demographics of T790M-positive subjects and T790M-negative subjects. --- T790M --- --- T790M ---
Disease characteristics of T790M-positive subjects and T790M-negative subjects. --- T790M ---
Disease characteristics of T790M-positive subjects and T790M-negative subjects. --- T790M --- --- T790M ---
Clinical Outcomes in T790M plasma-positive subejects. --- T790M ---
Clinical outcomes after osimertinib treatment between study subjects who are T790M plasma-positive. --- T790M ---
To analyze the concordance of T790M mutation status as determined by urine, plasma, and tissue/cytology T790M testing. --- T790M ---
To analyze the concordance of T790M mutation status as determined by urine, plasma, and tissue/cytology T790M testing. --- T790M --- --- T790M ---
Inclusion Criteria - Provision of written informed consent - Locally advanced (stage IIIB) or metastatic (stage IV) NSCLC, not amenable to curative surgery or radiotherapy - Confirmed EGFR sensitizing mutation (exon 19 deletion or exon 21 L858R ) in medical record - Progressed on previous EGFR TKI treatment, based on physician judgement, with or without additional lines of treatment - Suggested to undergo T790M mutation testing by treating physician, based on physician judgement Exclusion Criteria - Had been treated with osimertinib or any other 3rd generation T790M inhibitors - Enrollment in studies that prohibit participation in this observational study Inclusion Criteria - Provision of written informed consent - Locally advanced (stage IIIB) or metastatic (stage IV) NSCLC, not amenable to curative surgery or radiotherapy - Confirmed EGFR sensitizing mutation (exon 19 deletion or exon 21 L858R ) in medical record - Progressed on previous EGFR TKI treatment, based on physician judgement, with or without additional lines of treatment - Suggested to undergo T790M mutation testing by treating physician, based on physician judgement Exclusion Criteria - Had been treated with osimertinib or any other 3rd generation T790M inhibitors - Enrollment in studies that prohibit participation in this observational study Non-small Cell Lung Cancer Carcinoma, Non-Small-Cell Lung This is a multi-center, observational study of patients with locally advanced/metastatic NSCLC who progressed on previous EGFR TKI treatment. --- L858R --- --- T790M ---
Inclusion Criteria - Provision of written informed consent - Locally advanced (stage IIIB) or metastatic (stage IV) NSCLC, not amenable to curative surgery or radiotherapy - Confirmed EGFR sensitizing mutation (exon 19 deletion or exon 21 L858R ) in medical record - Progressed on previous EGFR TKI treatment, based on physician judgement, with or without additional lines of treatment - Suggested to undergo T790M mutation testing by treating physician, based on physician judgement Exclusion Criteria - Had been treated with osimertinib or any other 3rd generation T790M inhibitors - Enrollment in studies that prohibit participation in this observational study Inclusion Criteria - Provision of written informed consent - Locally advanced (stage IIIB) or metastatic (stage IV) NSCLC, not amenable to curative surgery or radiotherapy - Confirmed EGFR sensitizing mutation (exon 19 deletion or exon 21 L858R ) in medical record - Progressed on previous EGFR TKI treatment, based on physician judgement, with or without additional lines of treatment - Suggested to undergo T790M mutation testing by treating physician, based on physician judgement Exclusion Criteria - Had been treated with osimertinib or any other 3rd generation T790M inhibitors - Enrollment in studies that prohibit participation in this observational study Non-small Cell Lung Cancer Carcinoma, Non-Small-Cell Lung This is a multi-center, observational study of patients with locally advanced/metastatic NSCLC who progressed on previous EGFR TKI treatment. --- L858R --- --- T790M --- --- T790M ---
Inclusion Criteria - Provision of written informed consent - Locally advanced (stage IIIB) or metastatic (stage IV) NSCLC, not amenable to curative surgery or radiotherapy - Confirmed EGFR sensitizing mutation (exon 19 deletion or exon 21 L858R ) in medical record - Progressed on previous EGFR TKI treatment, based on physician judgement, with or without additional lines of treatment - Suggested to undergo T790M mutation testing by treating physician, based on physician judgement Exclusion Criteria - Had been treated with osimertinib or any other 3rd generation T790M inhibitors - Enrollment in studies that prohibit participation in this observational study Inclusion Criteria - Provision of written informed consent - Locally advanced (stage IIIB) or metastatic (stage IV) NSCLC, not amenable to curative surgery or radiotherapy - Confirmed EGFR sensitizing mutation (exon 19 deletion or exon 21 L858R ) in medical record - Progressed on previous EGFR TKI treatment, based on physician judgement, with or without additional lines of treatment - Suggested to undergo T790M mutation testing by treating physician, based on physician judgement Exclusion Criteria - Had been treated with osimertinib or any other 3rd generation T790M inhibitors - Enrollment in studies that prohibit participation in this observational study Non-small Cell Lung Cancer Carcinoma, Non-Small-Cell Lung This is a multi-center, observational study of patients with locally advanced/metastatic NSCLC who progressed on previous EGFR TKI treatment. --- L858R --- --- T790M --- --- T790M --- --- L858R --- --- T790M ---
Inclusion Criteria - Provision of written informed consent - Locally advanced (stage IIIB) or metastatic (stage IV) NSCLC, not amenable to curative surgery or radiotherapy - Confirmed EGFR sensitizing mutation (exon 19 deletion or exon 21 L858R ) in medical record - Progressed on previous EGFR TKI treatment, based on physician judgement, with or without additional lines of treatment - Suggested to undergo T790M mutation testing by treating physician, based on physician judgement Exclusion Criteria - Had been treated with osimertinib or any other 3rd generation T790M inhibitors - Enrollment in studies that prohibit participation in this observational study Inclusion Criteria - Provision of written informed consent - Locally advanced (stage IIIB) or metastatic (stage IV) NSCLC, not amenable to curative surgery or radiotherapy - Confirmed EGFR sensitizing mutation (exon 19 deletion or exon 21 L858R ) in medical record - Progressed on previous EGFR TKI treatment, based on physician judgement, with or without additional lines of treatment - Suggested to undergo T790M mutation testing by treating physician, based on physician judgement Exclusion Criteria - Had been treated with osimertinib or any other 3rd generation T790M inhibitors - Enrollment in studies that prohibit participation in this observational study Non-small Cell Lung Cancer Carcinoma, Non-Small-Cell Lung This is a multi-center, observational study of patients with locally advanced/metastatic NSCLC who progressed on previous EGFR TKI treatment. --- L858R --- --- T790M --- --- T790M --- --- L858R --- --- T790M --- --- T790M ---
Plasma circulating tumor DNA (ctDNA) and urine ctDNA will be analyzed by droplet digital PCR (ddPCR) for detection of T790M mutation and EGFR sensitizing mutations. --- T790M ---
Patients who are T790M plasma-negative, regardless of the urine testing results, will be recommended to undergo re-biopsy (defined as tissue sampling or cytology sampling), tissue/cytology T790M testing, and to provide a second plasma sample for a second plasma T790M test (tested by ddPCR). --- T790M ---
Patients who are T790M plasma-negative, regardless of the urine testing results, will be recommended to undergo re-biopsy (defined as tissue sampling or cytology sampling), tissue/cytology T790M testing, and to provide a second plasma sample for a second plasma T790M test (tested by ddPCR). --- T790M --- --- T790M ---
Patients who are T790M plasma-negative, regardless of the urine testing results, will be recommended to undergo re-biopsy (defined as tissue sampling or cytology sampling), tissue/cytology T790M testing, and to provide a second plasma sample for a second plasma T790M test (tested by ddPCR). --- T790M --- --- T790M --- --- T790M ---