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Spots Global Cancer Trial Database for Combination of Cetuximab With Afatinib for Patient With EGFR Mutated Lung Cancer

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Trial Identification

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

Interventions

Afatinib
Cetuximab

Study Description

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:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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