Afatinib in pretreated patients with advanced NSCLC harbouring HER2 exon 20 mutations

NICHE: Afatinib in NSCLC with HER2 mutation

The erbB family of proteins comprises the receptor tyrosine kinase EGFR and the closely related HER2, HER3 and HER4. HER2 mutations are identified in about 2% of non-mall-cell lung cancers (NSCLC) and appear to be critical for lung carcinogenesis. Clinically relevant HER2 mutations are clustered in exon 20 of the HER2 gene and commonly include small exon 20 insertions, single amino acid or clustered substitutions.

Afatinib is a selective and irreversible small molecule inhibitor of the erbB family of proteins. It has been shown to effectively inhibit EGFR, HER2 and HER4 phosphorylation resulting in subsequent suppression of tumour growth.

The NICHE trial was designed to evaluate the ability of afatinib to control disease in pre-treated patients with advanced NSCLC harbouring HER2 exon 20 mutations.

Trial Scheme



Primary Endpoint: Disease control lasting at least 12 weeks 
Secondary Endpoints:

Objective response

Progression free survival

Overall survival

Toxicities of treatment

Target Sample Size: 22 Patients (9 in stage I and 13 in stage II)
Final Accrual: 13 Patients
Protocol Release Date: June 2015
Trial Activation Date: 18 May 2015
First Patient In: 16 September 2015
Accrual Closure Date: 20 December  2016
Global Trial Completion Date: 17 August 2017

Trial Organisation

Trial Chairs: Solange Peters and Rafal Dziadziuszko
Sponsor: ETOP
Coordinating Group: ETOP
Participating Countries:
Germany, Netherlands, Spain, and Switzerland

EudraCT number: 2014-005098-35 NCT02369484



ETOP IBCSG Partners Foundation
Effingerstrasse 33
3008 Bern, Switzerland
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