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

NCT02845089 | Completed

• 1 other identifier: CA209-454
• Study Type: observational
• Target: 382
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (4)

• Patient Demographics at diagnosis with advanced/metastatic NSCLC

  at baseline

• Systemic treatments prescribed for NSCLC patients from treatment initiation through discontinuation

  approximately 12 months

• Duration of systemic treatments

  approximately 12 months

• Distribution of reasons for discontinuing treatment

  approximately 12 months

Secondary Outcomes (4)

• healthcare resource utilization in patients with advanced/metastatic NSCLC

  approximately 12 months

• Progression-Free Survival (PFS)

  approximately 12 months

• Overall Survival (OS)

  approximately 12 months

• Adverse Events (AEs)

  approximately 12 months

Study Arms (1)

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

A random sample of patients diagnosed with advanced/metastatic NSCLC from select oncology centers in UAE and KSA

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Related Links

• Investigator Inquiry Form

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2016
• First Posted: July 27, 2016
• Study Start: February 29, 2016
• Primary Completion: May 31, 2016
• Study Completion: August 15, 2017
• Last Updated: March 22, 2018

Record last verified: 2018-03