Clinical trial NCT03037086: Asia PDL1 Study Among NSCLC Patients
Official title: A Retrospective Non-Interventional Study of PD-L1 Prevalence and Clinical Outcomes for Non-Small Cell Lung Cancer in Asia-Pacific
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Locally Advanced or Metastatic NSCLC
Keywords: NSCLC
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2017-01-31
Enrollment: 658
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Characterization of PD-L1 expression among NSCLC patients
timeFrame: from NSCLC diagnosis date between January 2010 and December 2014 until index date, defined as the date of data abstraction
Secondary outcomes:
measure: Examination of overall survival by PD-L1 status among NSCLC patients
timeFrame: from NSCLC diagnosis date between January 2010 and December 2014 until index date, defined as the date of data abstraction
measure: Examination of disease-free survival (DFS) by PD-L1 status among NSCLC patients
timeFrame: from NSCLC diagnosis date between January 2010 and December 2014 until index date, defined as the date of data abstraction
measure: Examination of relapse-free survival (RFS) by PD-L1 status among NSCLC patients
timeFrame: from NSCLC diagnosis date between January 2010 and December 2014 until index date, defined as the date of data abstraction
measure: Examination of progression-free survival (PFS) by PD-L1 status among NSCLC patients
timeFrame: from NSCLC diagnosis date between January 2010 and December 2014 until index date, defined as the date of data abstraction
measure: Description of patient characteristics by PD-L1 status among NSCLC patients.
timeFrame: from NSCLC diagnosis date between January 2010 and December 2014 until index date, defined as the date of data abstraction
measure: Description of the overlap between PD-L1 expression and presence of EGFR, ALK or KRAS mutations among NSCLC patients
timeFrame: from NSCLC diagnosis date between January 2010 and December 2014 until index date, defined as the date of data abstraction
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Research Site
state: Guangdong
city: Iizuka-shi
country: Japan
facility: Research Site
state: Fukuoka-Ken
city: Fukushima-shi
country: Japan
facility: Research Site
state: Fukushima-Ken
city: Seoul
country: Korea, Republic of
facility: Research Site
Study officials:
affiliation: Asan Medical Center
name: Sang-We Kim, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Fukushima Medical University Hospital
name: Hiroyuki Suzuki, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Aso Co.,Ltd Iizuka Hospital
name: Noriyuki Ebi, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Sun Yat-sen University
name: Li Zhang, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Sichuan Province Cancer Hospital
name: Ping Yu, Prof.
role: PRINCIPAL_INVESTIGATOR
References: