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

Completed

• Conditions: Lung Cancer

• Registration Number: NCT02845089
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02-29
• Primary Completion: 2016-05-31
• Study First Submitted: 2016-07-08
• Study First Submitted QC: 2016-07-22
• Study First Posted: 2016-07-27
• Study Completion: 2017-08-15
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-20
• Last Update Posted: 2018-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 382

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Duration of systemic treatments	approximately 12 months
Patient Demographics at diagnosis with advanced/metastatic NSCLC	at baseline
Systemic treatments prescribed for NSCLC patients from treatment initiation through discontinuation	approximately 12 months
Distribution of reasons for discontinuing treatment	approximately 12 months

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	approximately 12 months
Adverse Events (AEs)	approximately 12 months
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
Progression-Free Survival (PFS)	approximately 12 months