Asia PDL1 Study Among NSCLC Patients (MEDI-APEX)

February 27, 2018 updated by: AstraZeneca

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
658

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Characterization of PD-L1 expression among NSCLC patients
Time Frame: from NSCLC diagnosis date between January 2010 and December 2014 until index date, defined as the date of data abstraction
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Examination of overall survival by PD-L1 status among NSCLC patients
Time Frame: from NSCLC diagnosis date between January 2010 and December 2014 until index date, defined as the date of data abstraction
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
Time Frame: from NSCLC diagnosis date between January 2010 and December 2014 until index date, defined as the date of data abstraction
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
Time Frame: from NSCLC diagnosis date between January 2010 and December 2014 until index date, defined as the date of data abstraction
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
Time Frame: from NSCLC diagnosis date between January 2010 and December 2014 until index date, defined as the date of data abstraction
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.
Time Frame: from NSCLC diagnosis date between January 2010 and December 2014 until index date, defined as the date of data abstraction
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
Time Frame: from NSCLC diagnosis date between January 2010 and December 2014 until index date, defined as the date of data abstraction
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 15, 2015

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 27, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 27, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 5, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 27, 2017

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 31, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 28, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D4191R00002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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