A multi-center prospective non-interventional study to understand the use of next generation sequencing (NGS) in patients with metastatic non-small cell lung cancer and metastatic colorectal cancer in Belgium.

Study type

• Study type:
  Non-interventional study

Non-interventional study

• Non-interventional study design:
  Cohort

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:
  250

Study design details

• Main study objective:
  The primary objectives of this study are to describe the real-world time from diagnosis of mCRC or mNSCLC to NGS test result and the real-world time from NGS test result to treatment in the overall cohort and across selected patient, clinical, disease, treatment and HCRU characteristics for patients who undergo NGS testing within routine clinical practice in Belgium.
• Outcomes:
  Real-world time from diagnosis to NGS test result, real-word time from NGS test result to treatment, number and reasons for resource use (per patient) post-index, and overall survival from index. Sample characteristics, NGS testing practices, age (years) at index date, sex at birth, relevant comorbidities, CCI score (if documented), time since diagnosis (at index), state of disease at primary diagnosis, tumor grade at primary diagnosis, BMI, smoking history, ECOG performance status (if documented), prior treatments, number and location of metastases, and histologic subtype.
• Data analysis plan:
  For the primary and secondary outcomes, statistical analysis will be descriptive with summary statistics calculated for quantitative variables (including the mean with standard deviation, median with interquartile range, and range) and frequencies and percentages for categorical variables. Estimated proportions (based on the Clopper-Pearson intervals) or 95% confidence intervals of the mean (based on the normal distribution and derived means and standard errors) may also be calculated. Time-to-event analyses will be conducted using Kaplan–Meier methodology. For the primary objective, the association of this time-to-event analysis with selected patient, clinical, treatment and HCRU outcomes will also be assessed. The specific outcomes to be used for the association analysis will be dependent on subgroup sample size and will be selected as pre-specified and will employ appropriate association statistics (e.g. hazard ratios from Cox regression), where applicable.