Status:

COMPLETED

Non-interventional Study for Real-world Data of Afatinib Treatment in First-line Setting and of Subsequent Therapies for Patients With Advanced Epidermal Growth Factor Receptor (EGFR) Mutation-positive Lung Adenocarcinoma

Lead Sponsor:

Boehringer Ingelheim

Conditions:

Non-squamous, Non-Small Cell Lung Cancer

Eligibility:

All Genders

20+ years

Brief Summary

The primary objective is to confirm Time on Treatment (TOT) related to afatinib treatment as first-line therapy in patients with Epidermal Growth Factor Receptor (EGFR) mutation-positive Non-Small Cel...

Eligibility Criteria

Inclusion

  • Patients with Epidermal Growth Factor Receptor (EGFR) mutation-positive advanced Non-Small Cell Lung Cancer (NSCLC)
  • Patients who were/are treated with afatinib in the first-line setting at least 20 months\* prior to data entry
  • Patients 20 years of age or older at the time of consent
  • Patients who provided consent to participate in this study (for cases of death or lost to follow-up, instructions from the Ethic Committee (EC)/Institutional Review Board (IRB) at each site should be followed) \* Inclusion will be restricted to patients with treatment initiation with afatinib at least 20 months prior to enrolment to avoid early censoring.

Exclusion

  • Any contraindication to afatinib as specified in the label of Giotrif®
  • Patients treated with afatinib within an interventional trial
  • Patients with active brain metastases at start of afatinib treatment\* \* Patients with non-active brain metastases (asymptomatic state) are eligible.

Key Trial Info

Start Date :

August 26 2021

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

October 16 2023

Estimated Enrollment :

805 Patients enrolled

Trial Details

Trial ID

NCT04795245

Start Date

August 26 2021

End Date

October 16 2023

Last Update

December 27 2024

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Nippon Boehringer Ingelheim Co., Ltd.

Tokyo, Japan, 141-6017