Asia PDL1 Study Among NSCLC Patients (MEDI-APEX)

AstraZeneca

Status: Completed

Conditions: Locally Advanced or Metastatic NSCLC

Study type: Observational

Funder types: Industry

Identifiers

NCT03037086

D4191R00002

Details and patient eligibility

About

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

Full 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.

Enrollment: 658 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

658 participants in 1 patient group

One single cohort

Description:

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.