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COMPLETED
NCT01350817
PHASE2

Erlotinib and Docetaxel in Second Line of Treatment in Patients With Non Small Cell Lung Cancer

Sponsor: University Hospital, Limoges

View on ClinicalTrials.gov

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

Interventions

DRUG

Erlotinib + docetaxel

docetaxel :75 mg/m² IV day 1 every 3 weeks with erlotinib:150 mg/d per os d2-d16

DRUG

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