Study type

Study type

Non-interventional study

Scope of the study

Disease epidemiology
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Medical condition to be studied

Non-small cell lung cancer
Large cell lung cancer recurrent
Adenosquamous 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)

Estimated number of subjects

1000
Study design details

Main study objective

To investigate potential associations between socioeconomic factors and lung cancer outcomes such as survival rate, late diagnosis, or access to innovative cancer drugs

Outcomes

1. To measure the survival at 24 months for metastatic lung cancer patients 2. To measure the survival at 24 months for non-metastatic lung cancer patients, • To estimate the probability to have metastasis since the first diagnosis • To estimate the probability of have a late lung cancer diagnosis • To calculate the use of innovative and expensive treatments

Data analysis plan

All analyses will be performed using SAS® software version 9.4 or later. A Statistical Analysis Plan (SAP) will be prepared with description of all statistical methods performed. Qualitative variables will be reported using frequencies (n) and percentages (%), while quantitative variables through mean and standard deviation (SD), median and IQR. All variables will be included into the multivariate models. To estimate the survival in lung cancer patients, a multivariate, semi-parametric mixed model regression (Cox models) will be implemented. Results will be expressed as hazard ratio (HR) and the corresponding 95% confidence interval (95% CI). The risk of metastatic lung cancer diagnosis at first diagnosis and the probability to have access to innovative cure will be measured using unconditional mixed logistic models. The risk of metastatic lung cancer diagnosis will be measured at index date while access to innovative cure will be measured throughout the follow-up period