NCT03037086

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
658

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2015

Geographic Reach
3 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2015

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

October 5, 2016

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 31, 2017

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2017

Completed
Last Updated

February 28, 2018

Status Verified

February 1, 2018

Enrollment Period

1.4 years

First QC Date

October 5, 2016

Last Update Submit

February 27, 2018

Conditions

Locally Advanced or Metastatic NSCLC

Keywords

NSCLC

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • \. Patients with locally advanced NSCLC with resectable disease and treated with curative intent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Research Site

Guangzhou, Guangdong, China

Location

Research Site

Iizuka-shi, Fukuoka, Japan

Location

Research Site

Fukushima, Fukushima, Japan

Location

Research Site

Seoul, South Korea

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Tumour tissue samples

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2016

First Posted

January 31, 2017

Study Start

October 15, 2015

Primary Completion

February 27, 2017

Study Completion

February 27, 2017

Last Updated

February 28, 2018

Record last verified: 2018-02

Locations

KR(1)CN(1)JP(2)