Non-Small Cell Lung Cancer, Lung Cancer, Cancer Clinical Trial
Official title:
An Observational Study of Patients With Newly Diagnosed Unresectable Stage IIIB or IV Non-Small Cell Lung Cancer (NSCLC) in China
| NCT number | NCT02458651 |
| Other study ID # | YO29443 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | June 26, 2015 |
| Est. completion date | October 30, 2018 |
| Verified date | November 2018 |
| Source | Hoffmann-La Roche |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 1378 |
| Est. completion date | October 30, 2018 |
| Est. primary completion date | October 30, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| China | 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 | Shanghai First People's Hospital | Shanghai | |
| China | Zhongshan Hospital Fudan University | Shanghai | |
| China | Union Hospital of Tongji Medical College, Dept. of Cancer Center; Cancer Center | Wuhan | |
| China | First Affiliated Hospital of Medical College of Xi'an Jiaotong University | Xi'an |
| Lead Sponsor | Collaborator |
|---|---|
| Hoffmann-La Roche |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Demographic and Socio-Behavioral Characteristics | At enrollment | ||
| Primary | Medical History Characteristics | At enrollment | ||
| Primary | 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 | ||
| Primary | 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 | ||
| Primary | 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 | ||
| Primary | Progression-Free Survival (PFS) | From enrollment to end of study up to 1.5 years | ||
| Primary | Overall Survival (OS) | From enrollment to end of study up to 1.5 years | ||
| Secondary | 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 | ||
| Secondary | Percentage of Serious Adverse Events (SAEs) | From enrollment to end of study up to 1.5 years | ||
| Secondary | Percentage of Adverse Events (AEs) | From enrollment to end of study up to 1.5 years | ||
| Secondary | Percentage of Non-Serious AEs of Special Interest (AESIs) | From enrollment to end of study up to 1.5 years |