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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03037086
Other study ID # D4191R00002
Secondary ID
Status Completed
Phase N/A
First received October 5, 2016
Last updated February 27, 2018
Start date October 15, 2015
Est. completion date February 27, 2017

Study information

Verified date February 2018
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 658
Est. completion date February 27, 2017
Est. primary completion date February 27, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms

  • Locally Advanced or Metastatic NSCLC

Locations

Country Name City State
China Research Site Guangzhou Guangdong
Japan Research Site Fukushima-shi Fukushima-Ken
Japan Research Site Iizuka-shi Fukuoka-Ken
Korea, Republic of Research Site Seoul

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Countries where clinical trial is conducted

China,  Japan,  Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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