Disease Characteristics, Treatment Patterns and Clinical Outcomes in Patients With Newly Diagnosed Unresectable Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC) in China
- Conditions
- Non-Small Cell Lung Cancer, Lung Cancer, Cancer
- Registration Number
- NCT02458651
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
The purpose of this observational study is to describe patient and disease characteristics as well as treatment patterns in Chinese patients with unresectable stage IIIB or IV non-small cell lung cancer (NSCLC). In addition, this study characterizes the clinical outcomes for various populations of patients defined by clinical and tumor characteristics, treatment patterns, and hospital category defined by city tier and geographic region.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1378
- Histologically/cytologically confirmed, unresectable Stage IIIB or IV non-small cell lung cancer (NSCLC)
- Received at least one anti-cancer treatment targeting unresectable Stage IIIB or IV NSCLC in the study site after study initiation
- Radiographic evidence of disease
- Prior systematic treatment for unresectable Stage IIIB or IV non-small cell lung cancer (NSCLC)
- Participation in any anti-cancer, regimen-specified clinical study of first-line treatment for unresectable Stage IIIB or IV NSCLC.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Grade of Eastern Cooperative Oncology Group (ECOG) Performance Status At enrollment, during quarterly and semi-annual follow up and at end of study up to 1.5 years Treatment Patterns of First-Line and Subsequent Treatments At enrollment, during quarterly and semi-annual follow up and at end of study up to 1.5 years Demographic and Socio-Behavioral Characteristics At enrollment Medical History Characteristics At enrollment Score Tumor Characteristics Based on Tumor Histology, Stage, Grade, and Lung Cancer Molecular Profile At enrollment, during quarterly and semi-annual follow up and at end of study up to 1.5 years Progression-Free Survival (PFS) From enrollment to end of study up to 1.5 years Overall Survival (OS) From enrollment to end of study up to 1.5 years
- Secondary Outcome Measures
Name Time Method Percentage of Serious Adverse Events (SAEs) From enrollment to end of study up to 1.5 years Score Health Economic Status Based on Household Income, Diagnosis and Treatment Costs, and Insurance Coverage At enrollment, during quarterly and semi-annual follow up and at end of study up to 1.5 years Percentage of Non-Serious AEs of Special Interest (AESIs) From enrollment to end of study up to 1.5 years Percentage of Adverse Events (AEs) From enrollment to end of study up to 1.5 years
Trial Locations
- Locations (11)
Cancer Hospital Chinese Academy of Medical Sciences.
🇨🇳Beijing, China
the First Hospital of Jilin University
🇨🇳Changchun, China
Sichuan Provincial Cancer Hospital
🇨🇳Chengdu, China
Third Affiliated Hospital of Third Military Medical University
🇨🇳ChongQing, China
Fujian Cancer Hospital
🇨🇳Fuzhou, China
Harbin Medical University Cancer Hospital
🇨🇳Harbin, China
The First Affiliate Hospital of Guangxi Medical University
🇨🇳Nanning, China
Zhongshan Hospital Fudan University
🇨🇳Shanghai, China
Shanghai First People's Hospital
🇨🇳Shanghai, China
Union Hospital of Tongji Medical College, Dept. of Cancer Center; Cancer Center
🇨🇳Wuhan, China
Scroll for more (1 remaining)Cancer Hospital Chinese Academy of Medical Sciences.🇨🇳Beijing, China