Asia PDL1 Study Among NSCLC Patients (MEDI-APEX)

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

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

Study Overview

• Status: Completed
• Conditions: Locally Advanced or Metastatic NSCLC

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 Type: Observational
• Enrollment (Actual): 658

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • Research Site
• Japan
  • Fukuoka-Ken
    • Iizuka-shi, Fukuoka-Ken, Japan
      • Research Site
  • Fukushima-Ken
    • Fukushima-shi, Fukushima-Ken, Japan
      • Research Site
• Korea, Republic of
  • Seoul, Korea, Republic of
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population will include patients with NSCLC, including SqCLC, diagnosed between 01 January 2010 and 31 December 2014

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
One single cohort; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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
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	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

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Sang-We Kim, Prof., Asan Medical Center; Principal Investigator: Hiroyuki Suzuki, Dr., Fukushima Medical University Hospital; Principal Investigator: Noriyuki Ebi, Dr., Aso Co.,Ltd Iizuka Hospital; Principal Investigator: Li Zhang, Prof., Sun Yat-sen University; Principal Investigator: Ping Yu, Prof., Sichuan Province Cancer Hospital

Publications and helpful links

Helpful Links

• CSR Synopsis

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 15, 2015
• Primary Completion (ACTUAL): February 27, 2017
• Study Completion (ACTUAL): February 27, 2017

Study Registration Dates

• First Submitted: October 5, 2016
• First Submitted That Met QC Criteria: January 27, 2017
• First Posted (ESTIMATE): January 31, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 28, 2018
• Last Update Submitted That Met QC Criteria: February 27, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: NSCLC
• Other Study ID Numbers: D4191R00002