This trial is active, not recruiting.

Condition lung cancer
Sponsor Bristol-Myers Squibb
Start date February 2016
End date May 2016
Trial size 382 participants
Trial identifier NCT02845089, CA209-454


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective
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)

Primary Outcomes

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

Secondary Outcomes

healthcare resource utilization in patients with advanced/metastatic NSCLC
time frame: approximately 12 months
Progression-Free Survival (PFS)
time frame: approximately 12 months
Overall Survival (OS)
time frame: approximately 12 months
Adverse Events (AEs)
time frame: approximately 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.