Afatinib in Patients With Non Small Cell Lung Cancer (NSCLC) With Epidermal Growth Factor Receptor (EGFR) Mutations

Phase 3

Completed

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

• Registration Number: NCT02044380
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The main aim of this study is to evaluate the safety and tolerability of afatinib in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring Epidermal Growth Factor Receptor (EGFR) mutation(s) and have never been treated with an EGFR-Tyrosine Kinase Inhibitor (TKI)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-22
• Study First Submitted QC: 2014-01-22
• Study First Posted: 2014-01-24
• Study Start: 2014-03
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2017-02
• Results First Submitted: 2017-02-15
• Results First Submitted QC: 2017-02-15
• Last Update Submitted: 2017-02-15
• Results First Posted: 2017-03-31
• Last Update Posted: 2017-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Afatinib	Afatinib	patient to receive a tablet containing 40 mg afatinib once a day, with the option to reduce the dose to 30 or 20 mg/day, based on individual tolerability

Primary Outcome Measures

Name	Time	Method
Safety Assesment	From first administration of treatment until 28 days after last drug administration, up to 80 weeks.	Safety was assessed by: 1. All serious adverse events (SAEs); 2. All adverse events (AEs) leading to treatment discontinuation or dose reduction of afatinib; 3. Non-serious AEs assessed by the treating physician as related to afatinib.

Trial Locations

Locations (1)

Boehringer Ingelheim Investigational Site; 🇨🇦 Montreal, Quebec, Canada