An Open Label Trial of Afatinib (Giotrif) in Treatment-naive (1st Line) or Chemotherapy Pre-treated Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Harboring EGFR Mutation(s)

Phase 3

Completed

• Conditions: Carcinoma, Non-Small-Cell Lung
• Interventions: Drug: Afatinib

• Registration Number: NCT01853826
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

To evaluate the safety and tolerability of afatinib (Giotrif) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR mutation(s) and have never been treated with an EGFR-TKI

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-05-13
• Study First Submitted QC: 2013-05-13
• Study First Posted: 2013-05-15
• Study Start: 2013-07-17
• Primary Completion: 2024-03-06
• Study Completion: 2024-03-06
• Results First Submitted: 2025-02-28
• Status Verified: 2025-04
• Results First Submitted QC: 2025-04-10
• Last Update Submitted: 2025-04-10
• Results First Posted: 2025-04-11
• Last Update Posted: 2025-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 481

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Afatinib treated-patients	Afatinib	Patients diagnosed with EGFR mutation positive non-small cell lung cancer (NSCLC) locally advanced or metastatic who have never been treated with EGFR tyrosine kinase inhibitors (TKI) received a daily dose of 40 milligrams (mg) of afatinib (Giotrif®), in the form of film-coated tablet over a 28 day cycle. Afatinib was taken orally with 250 milliliters (mL) of water at the same time of the day and without eating anything for at least 3 hours. Patients continued on treatment for as long as there was no disease progression or no other trial withdrawal criteria. The dose was reduced to 30 mg or 20 mg once daily when the initial dose was not tolerated by the patient.

Primary Outcome Measures

Name	Time	Method
Number of Patients With Adverse Events According to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0	From first drug administration to last drug administration plus 28 days of residual effect period. Up to 3866 days.	Number of patients with any treatment emergent adverse event (AE) according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.

Trial Locations

Locations (118)

The Prince of Wales Hospital; 🇦🇺 Randwick, New South Wales, Australia

Sunshine Hospital; 🇦🇺 AT Albans, Victoria, Australia

St John of God Murdoch; 🇦🇺 Murdoch, Western Australia, Australia

Medical University of Graz State Hospital - University Hospital Graz; 🇦🇹 Graz, Austria

Ordensklinikum Linz GmbH - Barmherzige Schwestern; 🇦🇹 Linz, Austria

Klinikum Wels - Grieskirchen GmbH; 🇦🇹 Wels, Austria

Klinik Penzing SMZ Baumgartner Hoehe; 🇦🇹 Wien, Austria

University Hospital Brno; 🇨🇿 Brno, Czechia

Hospital Hradec Kralove; 🇨🇿 Hradec Kralove, Czechia

University Hospital Ostrava; 🇨🇿 Ostrava, Czechia

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