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Treatment Patterns, Outcomes and Resource Use Study for Advanced Stage Non-Small Cell Lung Cancer (Squamous and Non-squamous) in the Kingdom of Saudi Arabia and United Arab Emirates

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT02845089
Collaborator
(none)
382
Enrollment
17.5
Actual Duration (Months)

Study Details

Study Description

Brief Summary

A retrospective observational longitudinal medical chart review study of randomly sampled patients diagnosed with advanced/metastatic NSCLC. The minimum observational period for each patient will be 12 months.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    382 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Treatment Patterns, Outcomes and Resource Use Study for Advanced Stage Non-Small Cell Lung Cancer (Squamous and Non-squamous) in the Kingdom of Saudi Arabia and United Arab Emirates
    Actual Study Start Date :
    Feb 29, 2016
    Actual Primary Completion Date :
    May 31, 2016
    Actual Study Completion Date :
    Aug 15, 2017

    Arms and Interventions

    Arm Intervention/Treatment
    Advanced/Metastatic NSCLC patients from UAE and KSA

    A random sample of patients diagnosed with advanced/metastatic non-small cell lung cancer (NSCLC) from select oncology centers in Kingdom of Saudi Arabia (KSA) and United Arab Emirates (UAE)

    Outcome Measures

    Primary Outcome Measures

    1. Patient Demographics at diagnosis with advanced/metastatic NSCLC [at baseline]

    2. Systemic treatments prescribed for NSCLC patients from treatment initiation through discontinuation [approximately 12 months]

    3. Duration of systemic treatments [approximately 12 months]

    4. Distribution of reasons for discontinuing treatment [approximately 12 months]

    Secondary Outcome Measures

    1. healthcare resource utilization in patients with advanced/metastatic NSCLC [approximately 12 months]

      NSCLC-related health care resources associated with the provision of systemic treatments and managing side effects of treatments: hospital admissions including emergency room visits

    2. Progression-Free Survival (PFS) [approximately 12 months]

    3. Overall Survival (OS) [approximately 12 months]

    4. Adverse Events (AEs) [approximately 12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Adults 18 years and older at the time of advanced/metastatic NSCLC diagnosis, and currently alive or deceased

    • Histologically confirmed diagnosis of advanced/metastatic NSCLC (squamous, non-squamous or NOS) stages IIIB/IV. First diagnosis of advanced/metastatic NSCLC between 01-Jan-2010 and 31-Mar-2014 (currently alive or deceased) with a minimum 12 months of potential observation period available in medical records

    • Medical history and treatment data must be available (or obtainable by SI) for chart abstraction from the date of advanced/metastatic diagnosis through most recent patient follow-up/contact. This also includes documentation of treatment by other physicians and inpatient hospital treatments within KSA or the Health Authority of Abu Dhabi (HAAD) system

    • Patients must have at least all data on age, gender, date of advanced NSCLC diagnosis, Line of Treatment (LOT) information (agent types and dosage), and date of last follow-up

    Exclusion Criteria:
    • Patient had enrolled in a cancer treatment-related clinical study at any time after the diagnosis of advanced/metastatic NSCLC

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT02845089
    Other Study ID Numbers:
    • CA209-454
    First Posted:
    Jul 27, 2016
    Last Update Posted:
    Mar 22, 2018
    Last Verified:
    Mar 1, 2018
    Additional relevant MeSH terms:
    Lung Neoplasms

    Study Results

    No Results Posted as of Mar 22, 2018