Disease Characteristics, Treatment Patterns and Clinical Outcomes in Patients With Newly Diagnosed Unresectable Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC) in China

Study Overview
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Brief Summary
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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.

Official Title
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An Observational Study of Patients With Newly Diagnosed Unresectable Stage IIIB or IV Non-Small Cell Lung Cancer (NSCLC) in China

Conditions
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Non-Small Cell Lung Cancer, Lung Cancer, Cancer

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Tier 1 and North<br>Site as described by tier level of the city where the site is located and by geographical location: Tier 1 city in northern region of China | Other: No intervention<br>* No intervention administered in this study<br>|
| Tier 1 and South<br>Site as described by tier level of the city where the site is located and by geographical location: Tier 1 city in southern region of China | Other: No intervention<br>* No intervention administered in this study<br>|
| Tier 2 and Middle<br>Site as described by tier level of the city where the site is located and by geographical location: Tier city in middle region of China | Other: No intervention<br>* No intervention administered in this study<br>|
| Tier 2 and North<br>Site as described by tier level of the city where the site is located and by geographical location: Tier 2 city in northern region of China | Other: No intervention<br>* No intervention administered in this study<br>|
| Tier 2 and South Eastern<br>Site as described by tier level of the city where the site is located and by geographical location: Tier 2 city in south eastern region of China | Other: No intervention<br>* No intervention administered in this study<br>|
| Tier 2 and South Western<br>Site as described by tier level of the city where the site is located and by geographical location: Tier 2 city in south western region of China | Other: No intervention<br>* No intervention administered in this study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Serious Adverse Events (SAEs) |  | 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 | 
| Percentage of Non-Serious AEs of Special Interest (AESIs) |  | From enrollment to end of study up to 1.5 years |