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OpenTrials
Completed

NCT Number: NCT02845089

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

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.

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Key information

Conditions

Lung Cancer 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

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. Patient Demographics at diagnosis with advanced/metastatic NSCLC

    Time frame: at baseline

  2. Systemic treatments prescribed for NSCLC patients from treatment initiation through discontinuation

    Time frame: approximately 12 months

  3. Duration of systemic treatments

    Time frame: approximately 12 months

  4. Distribution of reasons for discontinuing treatment

    Time frame: approximately 12 months

Secondary outcomes

  1. healthcare resource utilization in patients with advanced/metastatic NSCLC

    Time frame: 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)

    Time frame: approximately 12 months

  3. Overall Survival (OS)

    Time frame: approximately 12 months

  4. Adverse Events (AEs)

    Time frame: approximately 12 months

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Jul 27, 2016
Registry last updated
Mar 22, 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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