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.
Study Type
OBSERVATIONAL
Enrollment
658
Research Site
Guangzhou, Guangdong, China
Research Site
Iizuka-shi, Fukuoka, Japan
Research Site
Fukushima, Fukushima, Japan
Research Site
Seoul, South Korea
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.
Time frame: from NSCLC diagnosis date between January 2010 and December 2014 until index date, defined as the date of data abstraction
Examination of overall survival by PD-L1 status among NSCLC patients
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
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Time frame: from NSCLC diagnosis date between January 2010 and December 2014 until index date, defined as the date of data abstraction