Patient characteristics and treatment of non-small cell lung cancer (NSCLC) patients – a Danish nationwide registry study (20200328)

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Retrospective study

Study drug and medical condition

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

Population studied

• Short description of the study population:
  Adults aged 18 years or older diagnosed with non-small cell cancer (NSCLC) identified from the Danish registries between 1 January 2018 to 30 June 2020.; Inclusion criteria: ; - Adults aged ≥18 years at time of NSCLC diagnosis; - Diagnosed with incident locally advanced (Stage IIIB/C) or metastatic (Stage IV) NSCLC between 1 January 2018 to 30 June 2020. ; Exclusion criteria:; - Patients who immigrated to Denmark less than one year before NSCLC diagnosis; - Patients initially diagnosed with Stage I-IIIa NSCLC and progressed to advanced NSCLC during the study period will be excluded
• 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:
  Other
• Special population of interest, other:
  Non-small cell cancer patients
• Estimated number of subjects:
  8000

Study design details

• Main study objective:
  The main objective of the study is to estimate overall survival (OS) of patients with locally advanced or metastatic NSCLC
• Outcomes:
  Overall survival (OS), • Proportion of patients with locally advanced or metastatic NSCLC who are tested for KRAS • KRAS G12C mutation status • Demographics, clinical characteristics, tumor characteristics, treatment history (eg, line of therapy (LOT), type of treatment and time-to-next treatment (TTNT) and genetic mutation profile.
• Data analysis plan:
  There are no formal hypotheses for the study. Descriptive analyses will be performed. To describe time-to-event (OS and TTNT), Kaplan-Meier (KM) curves will be plotted, and KM estimates will be calculated. For survival objectives, analyses will be performed by line of treatment (LOT) and type of therapy.

Documents

Study results

20200328_ORSR Abstract_06DEC2022_Redacted