Skip to main content
OpenTrials
Completed

NCT Number: 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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Non-Small Cell Lung Cancer, Lung Cancer, Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

Cancer Hospital Chinese Academy of Medical Sciences., Beijing, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

No intervention administered in this study

Primary outcomes

  1. Demographic and Socio-Behavioral Characteristics

    Time frame: At enrollment

  2. Medical History Characteristics

    Time frame: At enrollment

  3. Score Tumor Characteristics Based on Tumor Histology, Stage, Grade, and Lung Cancer Molecular Profile

    Time frame: At enrollment, during quarterly and semi-annual follow up and at end of study up to 1.5 years

  4. Grade of Eastern Cooperative Oncology Group (ECOG) Performance Status

    Time frame: At enrollment, during quarterly and semi-annual follow up and at end of study up to 1.5 years

  5. Treatment Patterns of First-Line and Subsequent Treatments

    Time frame: At enrollment, during quarterly and semi-annual follow up and at end of study up to 1.5 years

  6. Progression-Free Survival (PFS)

    Time frame: From enrollment to end of study up to 1.5 years

  7. Overall Survival (OS)

    Time frame: From enrollment to end of study up to 1.5 years

Secondary outcomes

  1. Score Health Economic Status Based on Household Income, Diagnosis and Treatment Costs, and Insurance Coverage

    Time frame: At enrollment, during quarterly and semi-annual follow up and at end of study up to 1.5 years

  2. Percentage of Serious Adverse Events (SAEs)

    Time frame: From enrollment to end of study up to 1.5 years

  3. Percentage of Adverse Events (AEs)

    Time frame: From enrollment to end of study up to 1.5 years

  4. Percentage of Non-Serious AEs of Special Interest (AESIs)

    Time frame: From enrollment to end of study up to 1.5 years

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

An Observational Study of Patients With Newly Diagnosed Unresectable Stage IIIB or IV Non-Small Cell Lung Cancer (NSCLC) in China

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jun 1, 2015
Registry last updated
Nov 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.