NCT02369484

Afatinib in NSCLC With HER2 Mutation

Afatinib in Pretreated Patients With Advanced NSCLC Harbouring HER2 Exon 20 Mutations

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: ETOP IBCSG Partners Foundation · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the control of disease in pretreated patients with advanced non small cell lung cancer (NSCLC) harbouring HER2 exon 20 mutations as well as the safety and tolerability (how severe the side effects are) of the treatment with afatinib.

Detailed description

Previous clinical studies of NSCLC have shown that patients with tumors harboring specific gene mutations (changes) in the epithelial growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) showed better results after treatment with tyrosine kinase inhibitors (TKI), like afatinib (tradename Giotrif®) , compared with classical treatment with chemotherapy. The treatment with TKI has become a new standard-of-care for patient with advanced lung cancer and EGFR or ALK changes. Several novel mutations, which are candidates as targets for specific medication have been discovered. Human epidermal growth factor 2 (HER2, erbB-2/neu) is a protein of the so called ErbB family (including HER2 \[ErbB2\], ErbB3 and ErbB4). These proteins are involved in the growth and spread of cancer cells. Mutations in HER2 are found in about 2% of the NSCLC. Afatinib works by blocking the activity of the ErbB family proteins and can inhibit growth and spread of cancer cells. Afatinib is approved by the European and the Swiss Medicines Agencies for the treatment of adult patients with a specific type of cancer of the lung (non-small cell lung cancer) that is identified by a change (mutation) in the gene for EGFR as first treatment or if prior chemotherapy treatment has been insufficient. A total of 22 patients from centers around Europe are expected to be enrolled in this study over a period of 24 months. All patients will be treated in the same way. The study will take approximately 40 months to be completed. This clinical trial is conducted according to the applicable national laws and international guidelines.

Conditions

• NSCLC

Interventions

Type	Name	Description
DRUG	Afatinib	40mg p.o./ day until documented progression or unacceptable toxicity

Timeline

• Start date: 2015-09-16
• Primary completion: 2017-09-15
• Completion: 2017-09-15
• First posted: 2015-02-24
• Last updated: 2022-08-24
• Results posted: 2019-03-01

Locations

5 sites across 4 countries: Germany, Netherlands, Spain, Switzerland