Real World Data on Gi(l)Otrif® Dose Adjustment

Official Title

Real-world Data on Gi(l)Otrif® Dose Adjustment in First-line Treatment, TKI-naïve, Advanced Non-small Cell Lung Cancer Patients With EGFR Activating Mutations


This is a non-interventional, multi-country, multi-site study based on existing data from medical records of patients treated with Gi(l)otrif® as part of the routine treatment according to the approved label. Data from real-world will help to understand if dose modifications are done similar as in LUX-Lung 3 trial and if the outcome on safety and effectiveness are as in trial settings. Furthermore, data on modified starting doses, the underlying reasons and effects on safety and outcome are needed.

Trial Description

Primary Outcome:

  • Percentage of subjects with adverse drug reactions by severity class
  • Time on treatment with Gi(l)otrif®
  • Time to progression with Gi(l)otrif®
Secondary Outcome:
  • Percentage of subjects with a modified starting dose of Gi(l)otrif®
  • Reasons of modifying starting dose (The reasons for a modified starting dose will be listed)

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Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society