Asia PDL1 Study Among NSCLC Patients

NCT ID: NCT03037086

Last Updated: 2018-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

658 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-15

Study Completion Date

2017-02-27

Brief Summary

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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

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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.

Conditions

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Locally Advanced or Metastatic NSCLC

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sang-We Kim, Prof.

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Hiroyuki Suzuki, Dr.

Role: PRINCIPAL_INVESTIGATOR

Fukushima Medical University Hospital

Noriyuki Ebi, Dr.

Role: PRINCIPAL_INVESTIGATOR

Aso Co.,Ltd Iizuka Hospital

Li Zhang, Prof.

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Ping Yu, Prof.

Role: PRINCIPAL_INVESTIGATOR

Sichuan Province Cancer Hospital

Locations

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Research Site

Guangzhou, Guangdong, China

Site Status

Research Site

Iizuka-shi, Fukuoka, Japan

Site Status

Research Site

Fukushima, Fukushima, Japan

Site Status

Research Site

Seoul, , South Korea

Site Status

Countries

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China Japan South Korea

Related Links

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Other Identifiers

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D4191R00002

Identifier Type: -

Identifier Source: org_study_id

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