Asia PDL1 Study Among NSCLC Patients

Locally Advanced or Metastatic NSCLC Clinical Trial

— MEDI-APEX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03037086
• Other study ID #: D4191R00002
• 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
• 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.

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

External Links

•   CSR Synopsis