Clinical trial NCT02458651: Disease Characteristics, Treatment Patterns and Clinical Outcomes in Patients With Newly Diagnosed Unresectable Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC) in China
Official title: An Observational Study of Patients With Newly Diagnosed Unresectable Stage IIIB or IV Non-Small Cell Lung Cancer (NSCLC) in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Small Cell Lung Cancer, Lung Cancer, Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-06-01
Enrollment: 1378
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with newly diagnosed, unresectable Stage IIIB or IV non-small cell lung cancer (NSCLC)

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.


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.

Primary outcomes:
measure: Demographic and Socio-Behavioral Characteristics
timeFrame: At enrollment
measure: Medical History Characteristics
timeFrame: At enrollment
measure: Score Tumor Characteristics Based on Tumor Histology, Stage, Grade, and Lung Cancer Molecular Profile
timeFrame: At enrollment, during quarterly and semi-annual follow up and at end of study up to 1.5 years
measure: Grade of Eastern Cooperative Oncology Group (ECOG) Performance Status
timeFrame: At enrollment, during quarterly and semi-annual follow up and at end of study up to 1.5 years
measure: Treatment Patterns of First-Line and Subsequent Treatments
timeFrame: At enrollment, during quarterly and semi-annual follow up and at end of study up to 1.5 years
measure: Progression-Free Survival (PFS)
timeFrame: From enrollment to end of study up to 1.5 years
measure: Overall Survival (OS)
timeFrame: From enrollment to end of study up to 1.5 years
Secondary outcomes:
measure: Score Health Economic Status Based on Household Income, Diagnosis and Treatment Costs, and Insurance Coverage
timeFrame: At enrollment, during quarterly and semi-annual follow up and at end of study up to 1.5 years
measure: Percentage of Serious Adverse Events (SAEs)
timeFrame: From enrollment to end of study up to 1.5 years
measure: Percentage of Adverse Events (AEs)
timeFrame: From enrollment to end of study up to 1.5 years
measure: Percentage of Non-Serious AEs of Special Interest (AESIs)
timeFrame: From enrollment to end of study up to 1.5 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences.
city: Changchun
country: China
facility: the First Hospital of Jilin University
city: Chengdu
country: China
facility: Sichuan Provincial Cancer Hospital
city: ChongQing
country: China
facility: Third Affiliated Hospital of Third Military Medical University
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
city: Nanning
country: China
facility: The First Affiliate Hospital of Guangxi Medical University
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University
city: Shanghai
country: China
facility: Shanghai First People's Hospital
city: Wuhan
country: China
facility: Union Hospital of Tongji Medical College, Dept. of Cancer Center; Cancer Center
city: Xi'an
country: China
facility: First Affiliated Hospital of Medical College of Xi'an Jiaotong University
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: