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NCT Number: NCT03037086

Asia PDL1 Study Among NSCLC Patients

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

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Key information

Conditions

Locally Advanced or Metastatic NSCLC Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Guangzhou, Guangdong, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Retrospective Non-Interventional Study of PD-L1 Prevalence and Clinical Outcomes for Non-Small Cell Lung Cancer in Asia-Pacific

Acronym: MEDI-APEX

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jan 31, 2017
Registry last updated
Feb 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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