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

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02845089
• Other study ID #: CA209-454
• Status: Completed
• First received: July 8, 2016
• Last updated: March 20, 2018
• Start date: February 29, 2016
• Est. completion date: August 15, 2017

Study information

• Verified date: March 2018
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 382
• Est. completion date: August 15, 2017
• Est. primary completion date: May 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Demographics at diagnosis with advanced/metastatic NSCLC		at baseline
Primary	Systemic treatments prescribed for NSCLC patients from treatment initiation through discontinuation		approximately 12 months
Primary	Duration of systemic treatments		approximately 12 months
Primary	Distribution of reasons for discontinuing treatment		approximately 12 months
Secondary	healthcare resource utilization in patients with advanced/metastatic NSCLC	NSCLC-related health care resources associated with the provision of systemic treatments and managing side effects of treatments: hospital admissions including emergency room visits	approximately 12 months
Secondary	Progression-Free Survival (PFS)		approximately 12 months
Secondary	Overall Survival (OS)		approximately 12 months
Secondary	Adverse Events (AEs)		approximately 12 months

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form