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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02458651
Enrollment
1378
Registered
2015-06-01
Start date
2015-06-26
Completion date
2018-10-30
Last updated
2018-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Small Cell Lung Cancer, Lung Cancer, Cancer

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.

Interventions

OTHERNo intervention

No intervention administered in this study

Sponsors

Hoffmann-La Roche
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Overall Survival (OS)From enrollment to end of study up to 1.5 years
Score Tumor Characteristics Based on Tumor Histology, Stage, Grade, and Lung Cancer Molecular ProfileAt 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 StatusAt 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 TreatmentsAt 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
Demographic and Socio-Behavioral CharacteristicsAt enrollment
Medical History CharacteristicsAt enrollment

Secondary

MeasureTime frame
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
Score Health Economic Status Based on Household Income, Diagnosis and Treatment Costs, and Insurance CoverageAt enrollment, during quarterly and semi-annual follow up and at end of study up to 1.5 years

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026