Disease Characteristics, Treatment Patterns and Clinical Outcomes in Patients With Newly Diagnosed Unresectable Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC) in China
An Observational Study of Patients With Newly Diagnosed Unresectable Stage IIIB or IV Non-Small Cell Lung Cancer (NSCLC) in China
1 other identifier
observational
1,378
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2015
Typical duration for all trials
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 28, 2015
CompletedFirst Posted
Study publicly available on registry
June 1, 2015
CompletedStudy Start
First participant enrolled
June 26, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2018
CompletedNovember 9, 2018
November 1, 2018
3.3 years
May 28, 2015
November 8, 2018
Conditions
Outcome Measures
Primary Outcomes (7)
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 Outcomes (4)
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
Study Arms (6)
Tier 1 and North
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 1 and South
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 Middle
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
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
Tier 2 and South Eastern
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 2 and South Western
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
Interventions
No intervention administered in this study
Eligibility Criteria
Participants with newly diagnosed, unresectable Stage IIIB or IV non-small cell lung cancer (NSCLC)
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Cancer Hospital Chinese Academy of Medical Sciences.
Beijing, 100021, China
the First Hospital of Jilin University
Changchun, 130021, China
Sichuan Provincial Cancer Hospital
Chengdu, 610041, China
Third Affiliated Hospital of Third Military Medical University
Chongqing, 400042, China
Fujian Cancer Hospital
Fuzhou, 350014, China
Harbin Medical University Cancer Hospital
Harbin, 150081, China
The First Affiliate Hospital of Guangxi Medical University
Nanning, 530021, China
Zhongshan Hospital Fudan University
Shanghai, 200032, China
Shanghai First People's Hospital
Shanghai, 200080, China
Union Hospital of Tongji Medical College, Dept. of Cancer Center; Cancer Center
Wuhan, 430023, China
First Affiliated Hospital of Medical College of Xi'an Jiaotong University
Xi'an, 710061, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 28, 2015
First Posted
June 1, 2015
Study Start
June 26, 2015
Primary Completion
October 30, 2018
Study Completion
October 30, 2018
Last Updated
November 9, 2018
Record last verified: 2018-11