Clinical trial 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2016-07-27
Enrollment: 382
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A random sample of patients diagnosed with advanced/metastatic NSCLC from select oncology centers in UAE and KSA

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.


Eligibility criteria: 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

Primary outcomes:
measure: Patient Demographics at diagnosis with advanced/metastatic NSCLC
timeFrame: at baseline
measure: Systemic treatments prescribed for NSCLC patients from treatment initiation through discontinuation
timeFrame: approximately 12 months
measure: Duration of systemic treatments
timeFrame: approximately 12 months
measure: Distribution of reasons for discontinuing treatment
timeFrame: approximately 12 months
Secondary outcomes:
measure: healthcare resource utilization in patients with advanced/metastatic NSCLC
timeFrame: approximately 12 months
measure: Progression-Free Survival (PFS)
timeFrame: approximately 12 months
measure: Overall Survival (OS)
timeFrame: approximately 12 months
measure: Adverse Events (AEs)
timeFrame: approximately 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: