Asia PDL1 Study Among NSCLC Patients

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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A Retrospective Non-Interventional Study of PD-L1 Prevalence and Clinical Outcomes for Non-Small Cell Lung Cancer in Asia-Pacific

Conditions
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Locally Advanced or Metastatic NSCLC

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult male or female (according to age of majority as defined in local regulations). NSCLC diagnosis between 01 January 2010 and 31 December 2014. FFPET collected via core needle biopsy or resection and available in sufficient amount to complete PD-L1 testing. FFPET tissue samples collected for NSCLC original diagnosis determination or for further analysis (e.g. research or treatment purposes) until the index date. Patients with locally advanced or metastatic NSCLC who have initiated 1st line palliative chemotherapy by 31 December 2014. Exclusion Criteria: 1. Patients with locally advanced NSCLC with resectable disease and treated with curative intent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| One single cohort<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSCLC