Combination of Cetuximab With Afatinib for Patient With EGFR Mutated Lung Cancer
Status:
Active, not recruiting
Trial end date:
2020-12-01
Target enrollment:
Participant gender:
Summary
Until recently, the first line treatment of metastatic Non Small Cell Lung Cancer (NSCLC) was
a platine-based chemotherapy. It has been changed by the discovery of EGFR (Epidermal Growth
Factor Receptor) mutations and associated treatment with Tyrosine Kinase Inhibitor (TKI) of
EGFR. The superiority of EGFR TKI over chemotherapy for EGFR mutated patients has been proved
in several phase III trials with gefitinib, erlotinib or afatinib.
Nevertheless, all patients will progress after 9 to 12 months of treatment due to the
appearance of a treatment resistance.
Afatinib is an irreversible EGFR TKI. It binds to its receptor permanently.Contrary to
erlotinib and gefitinb which inhibits only EGFR, afatinib inhibits the kinase activity of all
HER family (Human Epidermal growth factor Receptor). Nevertheless, there is no proof that
afatinib delay the appearance of resistance.
Cetuximab is a monoclonal antibody which binds specifically with EGFR. The double inhibition
of EGFR by afatinib and cetuximab has demonstrated its efficacy in pre-clinical models. The
hypothesis of this study is that the combination between cetuximab and afatinib will permit
to delay or decrease the appearance of resistances.
Phase:
Phase 2
Details
Lead Sponsor:
Intergroupe Francophone de Cancerologie Thoracique