NCT03037086

Asia PDL1 Study Among NSCLC Patients

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 658 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Locally Advanced or Metastatic NSCLC

Timeline

• Start date: 2015-10-15
• Primary completion: 2017-02-27
• Completion: 2017-02-27
• First posted: 2017-01-31
• Last updated: 2018-02-28

Locations

4 sites across 3 countries: China, Japan, South Korea