Long-term non-interventional monitoring of patients newly diagnosed with bronchogenic carcinoma (LUCAS)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Disease registry - Assessment of scope and structure of care, treatment management, treatment sequencing, overall survival a progression-free survival

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Disease Registry

Study drug and medical condition

• Medical condition to be studied:
  Non-small cell lung cancer

  Small cell lung cancer

Population studied

• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Special population of interest:
  Renal impaired

  Hepatic impaired

  Immunocompromised
• Estimated number of subjects:
  1300

Study design details

• Main study objective:
  Mapping the bronchogenic carcinoma patient journey through diagnosis and treatment. Continuous data analysis. Assessment of scope and structure of care, treatment management, treatment sequencing, survival analysis.
• Outcomes:
  Description of bronchogenic carcinoma population characteristics, diagnostic and treatment patterns in participating centers, evaluation of gaps vs guidelines. survival analysis
• Data analysis plan:
  In patients with lung cancer the goal is to estimate and to describe treatment regimens, patient pathway, sequencing of treatments, progression-free survival (PFS) and overall survival (OS). The analysis will use of descriptive statistical methods. Exploratory statistical testing and modelling will be used to highlight interesting aspects of the data. Any test performed will be two-sided and carried out with a 5% α error rate without correction for multiplicity. Analysis of PFS and OS is based on the survivor function. All time-to-event analyses will be performed by using Kaplan-Meier methods including calculation of median survival times and 95% confidence intervals (CIs). Predictors and variables will be assessed. The study sponsor will also be able to perform ad hoc queries using the cohort data throughout the duration of the study period.