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Brief Title: Combination of Cetuximab With Afatinib for Patient With EGFR Mutated Lung Cancer
Official Title: Phase II Study Evaluating the Combination of Cetuximab With Afatinib as First-line Treatment for Patients With EGFR Mutated Non Small Cell Lung Cancer
Study ID: NCT02716311
Brief 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Centre Hospitalier du Pays d'Aix, Aix-en-Provence, , France
Clinique de L'Europe, Amiens, , France
Angers - CHU, Angers, , France
Annecy - CH, Annecy, , France
Bordeaux - Institut Bergonié, Bordeaux, , France
Bordeaux - Polyclinique Nord, Bordeaux, , France
Boulogne - Ambroise Paré, Boulogne-Billancourt, , France
Clermont-Ferrand - CHU, Clermont-Ferrand, , France
CH, Colmar, , France
CHRU Grenoble, Grenoble, , France
Centre Hospitalier - Pneumologie, Le Mans, , France
CHRU de Lille, Lille, , France
Lille - Polyclinique de la Louvière, Lille, , France
Lyon - Hôpital Privé Jean Mermoz, Lyon, , France
Institut Paoli Calmette, Marseille, , France
Montpellier - GCS Centre de Cancérologie du Grand Montpellier, Montpellier, , France
CH de Mulhouse, Mulhouse, , France
Nantes - ICO René Gauducheau, Nantes, , France
Nevers - CH, Nevers, , France
Centre Antoine Lacassagne, Nice, , France
Orléans - Hôpital de la Source, Orléans, , France
AP-HP Hopital Tenon - Pneumologie, Paris, , France
Paris - APHP Bichat, Paris, , France
Paris - APHP Saint-Louis, Paris, , France
Pau - CH, Pau, , France
Pontoise - CH, Pontoise, , France
Centre Hospitalier, Saint-Quentin, , France
Nouvel Hopital Civil - Pneumologie, Strasbourg, , France
Centre Hospitalier Intercommunal, Toulon, , France
HIA Saint Anne, Toulon, , France
Tours - CHU, Tours, , France
CH de Villefranche - Pneumologie, Villefranche, , France
Villeneuve d'Ascq - Hôpital Privé, Villeneuve-d'Ascq, , France
Name: Alexis CORTOT, MD, PhD
Affiliation: CHRU, Lille
Role: PRINCIPAL_INVESTIGATOR
Name: Jacques CADRANEL, MD, PhD
Affiliation: AP-HP Hôpital Tenon, Paris
Role: PRINCIPAL_INVESTIGATOR