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MEDI-APEX is a non-interventional, retrospective, cohort study to characterize PD-L1 expression and to assess the clinical characteristics and outcomes among NSCLC patients
MEDI-APEX is a non-interventional, retrospective, cohort study to characterize PD-L1 expression among NSCLC patients and to assess the clinical characteristics and outcomes of these patients with specific attention to EGFR, ALK, and KRAS mutations. The study will determine whether PD-L1 is a prognostic factor in the Asia-Pacific patient population; The study will enrol NSCLC patients with disease diagnosis between January 2010 and December 2014; The patients will be recruited from Asia-Pacific, potentially China, Japan, and South Korea. A total of approximately 750 patients will be enrolled in the study; around 250 NSCLC patients will be enrolled per country.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| One single cohort | One single cohort of NSCLC patients with disease diagnosis between January 2010 and December 2014. The locally advanced or metastatic NSCLC patients should have initiated 1st line palliative chemotherapy by end of 2014. |
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| Measure | Description | Time Frame |
|---|---|---|
| Characterization of PD-L1 expression among NSCLC patients | Characterization of PD-L1 expression among locally advanced, unresectable NSCLC patients (Stage III) and newly diagnosed Stage IV or recurrent metastatic NSCLC patients. | from NSCLC diagnosis date between January 2010 and December 2014 until index date, defined as the date of data abstraction |
| Measure | Description | Time Frame |
|---|---|---|
| Examination of overall survival by PD-L1 status among NSCLC patients | from NSCLC diagnosis date between January 2010 and December 2014 until index date, defined as the date of data abstraction | |
| Examination of disease-free survival (DFS) by PD-L1 status among NSCLC patients |
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Inclusion Criteria:
Exclusion Criteria:
1. Patients with locally advanced NSCLC with resectable disease and treated with curative intent.
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The study population will include patients with NSCLC, including SqCLC, diagnosed between 01 January 2010 and 31 December 2014
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| Name | Affiliation | Role |
|---|---|---|
| Sang-We Kim, Prof. | Asan Medical Center | Principal Investigator |
| Hiroyuki Suzuki, Dr. | Fukushima Medical University Hospital | Principal Investigator |
| Noriyuki Ebi, Dr. | Aso Co.,Ltd Iizuka Hospital | Principal Investigator |
| Li Zhang, Prof. | Sun Yat-Sen University Cancer Center | Principal Investigator |
| Ping Yu, Prof. | Sichuan Province Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Guangzhou | Guangdong | China | |||
| 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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Tumour tissue samples
| from NSCLC diagnosis date between January 2010 and December 2014 until index date, defined as the date of data abstraction |
| Examination of relapse-free survival (RFS) by PD-L1 status among NSCLC patients | from NSCLC diagnosis date between January 2010 and December 2014 until index date, defined as the date of data abstraction |
| Examination of progression-free survival (PFS) by PD-L1 status among NSCLC patients | from NSCLC diagnosis date between January 2010 and December 2014 until index date, defined as the date of data abstraction |
| Description of patient characteristics by PD-L1 status among NSCLC patients. | from NSCLC diagnosis date between January 2010 and December 2014 until index date, defined as the date of data abstraction |
| Description of the overlap between PD-L1 expression and presence of EGFR, ALK or KRAS mutations among NSCLC patients | And the prevalence of PD-L1 expression ≥25%, and ≥90%, will be calculated for each mutation status for the EGFR, ALK and KRAS biomarkers. | from NSCLC diagnosis date between January 2010 and December 2014 until index date, defined as the date of data abstraction |
| Iizuka-shi |
| Fukuoka |
| Japan |
| Research Site | Fukushima | Fukushima | Japan |
| Research Site | Seoul | South Korea |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |