An Observational Study of Patients With Newly Diagnosed Unresectable Stage IIIB or IV Non-Small Cell Lung Cancer (NSCLC) in China
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Non-Small Cell Lung Cancer, Lung Cancer, Cancer
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 1378
- Locations
- 11
- Primary Endpoint
- Demographic and Socio-Behavioral Characteristics
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Demographic and Socio-Behavioral Characteristics
Time Frame: At enrollment
Medical History Characteristics
Time Frame: At enrollment
Score Tumor Characteristics Based on Tumor Histology, Stage, Grade, and Lung Cancer Molecular Profile
Time Frame: At enrollment, during quarterly and semi-annual follow up and at end of study up to 1.5 years
Progression-Free Survival (PFS)
Time Frame: From enrollment to end of study up to 1.5 years
Treatment Patterns of First-Line and Subsequent Treatments
Time Frame: At enrollment, during quarterly and semi-annual follow up and at end of study up to 1.5 years
Grade of Eastern Cooperative Oncology Group (ECOG) Performance Status
Time Frame: At enrollment, during quarterly and semi-annual follow up and at end of study up to 1.5 years
Overall Survival (OS)
Time Frame: From enrollment to end of study up to 1.5 years
Secondary Outcomes
- Percentage of Non-Serious AEs of Special Interest (AESIs)(From enrollment to end of study up to 1.5 years)
- 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 Adverse Events (AEs)(From enrollment to end of study up to 1.5 years)