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

Completed

• Conditions: Non-Small Cell Lung Cancer, Lung Cancer, Cancer
• Interventions: Other: No intervention

• 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

Study Timeline

• Study First Submitted: 2015-05-28
• Study First Submitted QC: 2015-05-28
• Study First Posted: 2015-06-01
• Study Start: 2015-06-26
• Primary Completion: 2018-10-30
• Study Completion: 2018-10-30
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-08
• Last Update Posted: 2018-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1378

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Tier 2 and South Eastern	No intervention	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
Tier 1 and South	No intervention	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
Tier 2 and South Western	No intervention	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
Tier 1 and North	No intervention	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
Tier 2 and Middle	No intervention	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
Tier 2 and North	No intervention	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

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
Medical History Characteristics	At enrollment
Demographic and Socio-Behavioral 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
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
Overall Survival (OS)	From enrollment to end of study up to 1.5 years

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (11)

Sichuan Provincial Cancer Hospital; 🇨🇳 Chengdu, China

Cancer Hospital Chinese Academy of Medical Sciences.; 🇨🇳 Beijing, China

the First Hospital of Jilin University; 🇨🇳 Changchun, China

Third Affiliated Hospital of Third Military Medical University; 🇨🇳 ChongQing, China

Harbin Medical University Cancer Hospital; 🇨🇳 Harbin, China

The First Affiliate Hospital of Guangxi Medical University; 🇨🇳 Nanning, China

Union Hospital of Tongji Medical College, Dept. of Cancer Center; Cancer Center; 🇨🇳 Wuhan, China

Zhongshan Hospital Fudan University; 🇨🇳 Shanghai, China

First Affiliated Hospital of Medical College of Xi'an Jiaotong University; 🇨🇳 Xi'an, China

Shanghai First People's Hospital; 🇨🇳 Shanghai, China

Fujian Cancer Hospital; 🇨🇳 Fuzhou, China