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Erlotinib and Docetaxel in Second Line of Treatment in Patients With Non Small Cell Lung Cancer
Sponsor: University Hospital, Limoges
Summary
This 2 arms study will compare the efficacy and safety of treatment with sequential erlotinib plus docetaxel therapy versus docetaxel alone as second line treatment in patients with recurrent non-small cell lung cancer. Patients will be randomized to receive in group 1(experimental arm): docetaxel :75 mg/m² IV day 1 every 3 weeks with erlotinib:150 mg/d per os d2-d16 and group 2 (control arm): docetaxel :75 mg/m² IV day 1 every 3 weeks. The anticipated time on study treatment is until disease progression. Target sample size is 156. The main of this study is to determine the relevance of the association sequential erlotinib and docetaxel in terms of progression-free survival .
Official title: Randomized Open Non Comparative Multicenter Phase II Study of Sequential Erlotinib With Docetaxel Versus Docetaxel Alone in Second Line of Treatment in Patients With Non Small Cell Lung Cancer After Failure of First Line Chemotherapy
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
156
Start Date
2011-06
Completion Date
2014-01
Last Updated
2026-05-15
Healthy Volunteers
No
Conditions
Interventions
Erlotinib + docetaxel
docetaxel :75 mg/m² IV day 1 every 3 weeks with erlotinib:150 mg/d per os d2-d16
Docetaxel
docetaxel :75 mg/m² IV day 1 every 3 weeks.
Locations (30)
Service de Pneumologie, CHU Angers
Angers, France
Service de pneumologie; Centre Hospitalier d'Annecy
Annecy, France
Service de Pneumologie; Centre Hospitalier
Beauvais, France
Service de Pneumologie
Beauvais, France
Service de Pneumologie
Bordeaux, France
CHU Brest
Brest, France
Service de Pneumologie
Charleville Mezière, France
Service de Pneumologie ; Centre hospitalier
Charleville-Mézières, France
Service de Pneumologie
Créteil, France
Service de Pneumologie; Centre Hospitalier
Draguignan, France
Service de Pneumologie
Draguignan, France
Service de Pneumologie
Elbeuf, France
Service de Pneumologie
Gap, France
Département de Pathologie Respiratoire du CHU de Limoges
Limoges, France
Service de Pneumologie, Hôpital de la Croix Rousse
Lyon, France
Service de Pneumologie-Neurologie ; Centre Hospitalier F. Quesnay
Mantes-la-Jolie, France
Département des Maladies Respiratoires ; Hôpital Sainte Marguerite
Marseille, France
CH de Meaux
Meaux, France
Service de Pneumologie
Meaux, France
Service de Pneumologie
Mulhouse, France
Service de Pneumologie - Hôpital St Antoine, Paris
Paris, France
Service de Pneumologie-Allergologie; Centre Hospitalier Général
Périgueux, France
CHU Reims
Reims, France
Service de Pneumologie, Hôpital Pontchailloux
Rennes, France
Service de Pneumologie; CHG de Roanne
Roanne, France
Clinique Pneumologique; Hôpital Charles Nicolle
Rouen, France
Service de Pneumologie; Hôpital Bois Guillaume
Rouen, France
Hôpital Charles Nicolle, Service de Pneumologie
Rouen, France
Service de Pneumologie, Hôpital Nord
Saint-Etienne, France
Service de Pneumologie
Villefranche, France