An active surveillance to monitor the real world safety in Indian patients prescribed nintedanib for the treatment of locally advanced, metastatic or recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumour histology after first-line chemotherapy.

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  To evaluate real-world safety of nintedanib in Indian patients with non-small cell lung cancer of adenocarcinoma histology after first line of chemotherapy

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine, other:
  Nintedanib
• Medical condition to be studied:
  Non-small cell lung cancer stage IIIB

  Non-small cell lung cancer stage IV

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:
  200

Study design details

• Main study objective:
  To evaluate real-world safety of nintedanib in Indian patients with non-small cell lung cancer of adenocarcinoma histology after first line of chemotherapy.
• Outcomes:
  Safety The primary outcome  Occurrence of ADRs (serious and non-serious)  Occurrence of AEs (serious and fatal), Safety Secondary outcome  Percentage of patients who require nintedanib dose reductions and discontinuations due to adverse events.
• Data analysis plan:
  Analyses will be descriptive in nature including means, medians, standard deviation and interquartile range for continuous variables, and frequencies and percentages for binary and categorical variables with the corresponding 95% confidence intervals. For safety outcomes, incidence rates with corresponding 95% confidence intervals will be calculated. Baseline characteristics of consecutive 100 NSCLC patients not treated with nintedanib will be used to compare the patients profile with the nintedanib users and will allow us to put the safety data of nintedanib into perspective. Whenever patient profiles differ between those treated with combination of nintedanib and docetaxel and single agent docetaxel, cautious interpretation is required when comparing with nintedanib treated populations from other trials / registries.