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Spots Global Cancer Trial Database for 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

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Trial Identification

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

Study Description

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:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Radj GERVAIS, MD

Affiliation: Centre François Baclesse - CAEN- FRANCE

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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