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Trial record 3 of 5024 for:    NSCLC

Asia PDL1 Study Among NSCLC Patients (MEDI-APEX)

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ClinicalTrials.gov Identifier: NCT03037086
Recruitment Status : Completed
First Posted : January 31, 2017
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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

Condition or disease
Locally Advanced or Metastatic NSCLC

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.

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Study Type : Observational
Actual Enrollment : 658 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Retrospective Non-Interventional Study of PD-L1 Prevalence and Clinical Outcomes for Non-Small Cell Lung Cancer in Asia-Pacific
Actual Study Start Date : October 15, 2015
Actual Primary Completion Date : February 27, 2017
Actual Study Completion Date : February 27, 2017

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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.


Biospecimen Retention:   Samples With DNA
Tumour tissue samples


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03037086


Locations
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China, Guangdong
Research Site
Guangzhou, Guangdong, China
Japan
Research Site
Iizuka-shi, Fukuoka-Ken, Japan
Research Site
Fukushima-shi, Fukushima-Ken, Japan
Korea, Republic of
Research Site
Seoul, Korea, Republic of
Sponsors and Collaborators
AstraZeneca
Investigators
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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

Additional Information:
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03037086     History of Changes
Other Study ID Numbers: D4191R00002
First Posted: January 31, 2017    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018

Keywords provided by AstraZeneca:
NSCLC