Locally Advanced or Metastatic NSCLCMEDI-APEXNCT03037086
Asia PDL1 Study Among NSCLC Patients
An observational study of Locally Advanced or Metastatic NSCLC, run by AstraZeneca at 4 sites in 3 countries.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced or Metastatic NSCLC
- How many people
- 658 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 15 Oct 2015to 27 Feb 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will include patients with NSCLC, including SqCLC, diagnosed between 01 January 2010 and 31 December 2014
Who may be able to join
- Adult male or female (according to age of majority as defined in local regulations).
- NSCLC diagnosis between 01 January 2010 and 31 December 2014.
- FFPET collected via core needle biopsy or resection and available in sufficient amount to complete PD-L1 testing.
- FFPET tissue samples collected for NSCLC original diagnosis determination or for further analysis (e.g. research or treatment purposes) until the index date.
- Patients with locally advanced or metastatic NSCLC who have initiated 1st line palliative chemotherapy by 31 December 2014.
Who cannot join
- 1. Patients with locally advanced NSCLC with resectable disease and treated with curative intent.
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Japan2 sites
Research Site
Fukushima, Fukushima
Research Site
Iizuka-shi, Fukuoka
About this study
Official title: 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
Read the 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.
- Conditions
- Locally Advanced or Metastatic NSCLC
- Keywords
- NSCLC
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from NSCLC diagnosis date between January 2010 and December 2014 until index date, defined as the date of data abstraction
Secondary outcomes (6)
Examination of overall survival by PD-L1 status among NSCLC patients
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: from NSCLC diagnosis date between January 2010 and December 2014 until index date, defined as the date of data abstraction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2017 (estimated)
- Study start15 Oct 2015
- Primary completion27 Feb 2017
- Study completion27 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced or Metastatic NSCLCStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 658 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sang-We Kim, Prof., Principal investigator, Asan Medical CenterHiroyuki Suzuki, Dr., Principal investigator, Fukushima Medical University HospitalNoriyuki Ebi, Dr., Principal investigator, Aso Co.,Ltd Iizuka HospitalLi Zhang, Prof., Principal investigator, Sun Yat-Sen University Cancer CenterPing Yu, Prof., Principal investigator, Sichuan Province Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03037086
- Sponsor's protocol ID
- D4191R00002
- Acronym
- MEDI-APEX
- Status last verified
- Feb 2018
- First submitted
- 5 Oct 2016
- Last updated
- 28 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Non-Interventional Study of PD-L1 Prevalence and Clinical Outcomes for Non-Small Cell Lung Cancer in Asia-Pacific
- ClinicalTrials.gov ID
- NCT03037086
- Acronym / sponsor ID
- MEDI-APEX / D4191R00002
- Conditions
- Locally Advanced or Metastatic NSCLC
- Keywords
- NSCLC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 658 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2015 (actual)
- Primary completion
- 27 Feb 2017 (actual)
- Study completion
- 27 Feb 2017 (actual)
- First posted
- 31 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include patients with NSCLC, including SqCLC, diagnosed between 01 January 2010 and 31 December 2014
Key inclusion criteria (5 listed)
- Adult male or female (according to age of majority as defined in local regulations).
- NSCLC diagnosis between 01 January 2010 and 31 December 2014.
- FFPET collected via core needle biopsy or resection and available in sufficient amount to complete PD-L1 testing.
- FFPET tissue samples collected for NSCLC original diagnosis determination or for further analysis (e.g. research or treatment purposes) until the index date.
- Patients with locally advanced or metastatic NSCLC who have initiated 1st line palliative chemotherapy by 31 December 2014.
Key exclusion criteria (1 listed)
- 1. Patients with locally advanced NSCLC with resectable disease and treated with curative intent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
6 secondary outcomes
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2018.
- CSR SynopsisLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sang-We Kim, Prof. principal investigator
Asan Medical Center
Hiroyuki Suzuki, Dr. principal investigator
Fukushima Medical University Hospital
Noriyuki Ebi, Dr. principal investigator
Aso Co.,Ltd Iizuka Hospital
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Locally Advanced or Metastatic NSCLC, run by AstraZeneca at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Japan, China, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2018.