Asia PDL1 Study Among NSCLC Patients

Completed

• Conditions: Locally Advanced or Metastatic NSCLC

• Registration Number: NCT03037086
• Lead Sponsor: AstraZeneca

Brief 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.

Study Timeline

• Study Start: 2015-10-15
• Study First Submitted: 2016-10-05
• Study First Submitted QC: 2017-01-27
• Study First Posted: 2017-01-31
• Primary Completion: 2017-02-27
• Study Completion: 2017-02-27
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-27
• Last Update Posted: 2018-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 658

Inclusion Criteria

1. Adult male or female (according to age of majority as defined in local regulations).
2. NSCLC diagnosis between 01 January 2010 and 31 December 2014.
3. FFPET collected via core needle biopsy or resection and available in sufficient amount to complete PD-L1 testing.
4. FFPET tissue samples collected for NSCLC original diagnosis determination or for further analysis (e.g. research or treatment purposes) until the index date.
5. 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Characterization of PD-L1 expression among NSCLC patients	from NSCLC diagnosis date between January 2010 and December 2014 until index date, defined as the date of data abstraction	Characterization of PD-L1 expression among locally advanced, unresectable NSCLC patients (Stage III) and newly diagnosed Stage IV or recurrent metastatic NSCLC patients.

Secondary Outcome Measures

Name	Time	Method
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 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	from NSCLC diagnosis date between January 2010 and December 2014 until index date, defined as the date of data abstraction	And the prevalence of PD-L1 expression ≥25%, and ≥90%, will be calculated for each mutation status for the EGFR, ALK and KRAS biomarkers.
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

Trial Locations

Locations (1)

Research Site; 🇰🇷 Seoul, Korea, Republic of