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Brief Title: A Multicenter Randomized Phase III Study Comparing Second-line Treatment With Chemotherapy Associated or Not to Erlotinib in NSCLC Patients With Secondary Resistance to TKI-EGFR
Official Title: A Multicenter Randomized Phase III Study Comparing Second-line Treatment With Chemotherapy Associated or Not to Erlotinib in NSCLC Patients With Secondary Resistance to TKI-EGFR
Study ID: NCT02178397
Brief Summary: The current first line treatment of patients with EGFR activating mutation lung cancer is EGFR TKI. Compared to platinum-based chemotherapy, EGFR-TKIs are superior in terms of response rate and progression-free survival. However, an acquired resistance occurs almost constantly. The second-line treatment includes platinum-based chemotherapy in the absence of contraindication. This chemotherapy is then administered after discontinuing EGFR TKIs. However, a rebound phenomenon of the disease was described in patients who discontinued EGFR TKIs. Some clinical teams therefore recommend, as a precaution, in order to avoid any withdrawal phenomenon, to never discontinue EGFR TKIs in patients developing an EGFR TKI acquired resistance. It seems therefore useful to conduct a study to better define the therapeutic strategy to adopt in patients developing an acquired resistance after having received EGFR TKIs as first line treatment.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
CH, Aix En Provence, , France
CH, Amiens, , France
CHRU, Angers, , France
CH, Annecy, , France
CHU, Brest, , France
Centre François BACLESSE, Caen, , France
CHIC, Creteil, , France
CH, Draguignan, , France
CH, Elbeuf, , France
CHIC, GAP, , France
Ch La Roche/Yon, La Roche/yon, , France
Centre Hospitalier, Le MANS, , France
Centre Oscar Lambret, Lille, , France
CHU, Limoges, , France
CH, Longjumeau, , France
CH, Lorient, , France
CH, Macon, , France
CH, Mantes La Jolie, , France
Institut Paoli Calmettes, Marseille, , France
AP-HM - Hôpital Nord, Marseille, , France
CH, Meaux, , France
Centre Hospitalier Intercommunal, Meulan, , France
CH, PAU, , France
Centre Catalan, Perpignan, , France
CHU, Rennes, , France
CH, Roanne, , France
CHU, Rouen, , France
CH, Salon de Provence, , France
CH, Sens, , France
CH, St BRIEUC, , France
Institut de Cancérologie de la Loire, St ETIENNE, , France
Centre Paul Strauss, Strasbourg, , France
CH, Tarbes, , France
Hôpital d'instruction des Armées Sainte-Anne, Toulon, , France
CH, Villefranche, , France
Name: Radj GERVAIS, MD
Affiliation: Centre François Baclesse - CAEN- FRANCE
Role: PRINCIPAL_INVESTIGATOR