Phase III Study (Tarceva®) vs Chemotherapy to Treat Advanced Non-Small Cell Lung Cancer in Patients With Mutations in the TK Domain of EGFR

PHASE3CompletedINTERVENTIONAL
Enrollment

174

Participants

Timeline

Start Date

February 15, 2007

Primary Completion Date

April 11, 2012

Study Completion Date

December 31, 2012

Conditions
Non-Small Cell Lung Cancer
Interventions
DRUG

Erlotinib

"150 mg/day Patients will receive treatment until disease progression or unacceptable toxicity.~For all practical effects a treatment cycle will be defined as three weeks of continuous treatment with erlotinib"

DRUG

Carboplatin

"Gemcitabine 1000 mg/m2 days 1 and 8 and Carboplatin AUC = 5 day 1, every 21 days.~Docetaxel (75 mg/m2) /carboplatin (AUC=6); Gemcitabine (1000 mg/m2; day 1 and 8) / Carboplatin (AUC=5)~Patients in the chemotherapy arm will receive the treatment until disease progression or unacceptable toxicity occurs, or until a maximum of 4 treatment cycles are given."

DRUG

Gemcitabin

Cisplatin (75 mg/m2) / Gemcitabine (1250 mg/m2; day 1 and 8) Patients in the chemotherapy arm will receive the treatment until disease progression or unacceptable toxicity occurs, or until a maximum of 4 treatment cycles are given.

DRUG

Docetaxel

Cisplatin (75 mg/m2) / Docetaxel (75 mg/m2) Patients in the chemotherapy arm will receive the treatment until disease progression or unacceptable toxicity occurs, or until a maximum of 4 treatment cycles are given.

DRUG

Cisplatin

Cisplatin (75 mg/m2) / Docetaxel (75 mg/m2) Patients in the chemotherapy arm will receive the treatment until disease progression or unacceptable toxicity occurs, or until a maximum of 4 treatment cycles are given.

Trial Locations (76)

12002

H. Provincial de Castellón, Castellon

14000

Centre François Baclesse, Caen

14004

H. Reina Sofía, Córdoba

15006

Complejo Hosp. Univ. Juan Canalejo, A Coruña

17007

ICO Girona -H. Dr. Josep Trueta, Girona

18014

H. Virgen de las Nieves, Granada

20014

H. de Donostia, Donostia / San Sebastian

23007

Complejo Hospitalario de Jaén, Jaén

25198

H. Arnau de Vilanova, Lleida

28006

H. de la Princesa, Madrid

28007

H. Gregorio Marañón, Madrid

28034

H. Ruber Internacional, Madrid

28035

H.U. Puerta de Hierro, Madrid

28040

Fundación Jimenez Diaz, Madrid

Hospial Clinico San Carlos, Madrid

28046

H. La Paz, Madrid

28922

F.H.Alcorcón, Alcorcón

28942

H. Fuenlabrada, Fuenlabrada

29010

H. Carlos Haya, Málaga

H.C.Universitario Virgen de la Victoria, Málaga

29200

Hôpital Auguste Morvan, Brest

31059

Hôpital Larrey, Toulouse

33081

CRO di Aviano, Aviano

35016

Hospital Insular Gran Canaria, Las Palmas de Gran Canaria

35033

CHU Rennes Hôpital Ponchaillou, Rennes

38010

H. Ntra. Sra. de la Candelaria, Santa Cruz de Tenerife

39008

H. Marqués de Valdecilla, Santander

41013

H. Virgen del Rocío, Seville

41014

H. Nuestra Sra. de Valme, Seville

46010

H.C.U.Valencia, Valencia

46014

H. General U. de Valencia, Valencia

46015

H. Arnau de Vilanova Valencia, Valencia

46017

H. Dr. Peset, Valencia

48903

Hospital de Cruces, Barakaldo

50009

H. Miguel Servet, Zaragoza

59000

Centre Oscar Lambret, Lille

59009

H. Clínico Lozano Blesa, Zaragoza

75571

Hôpital Saint Antoine, Paris

80131

AO Monaldi, Napoli

87042

Hôpital du Cluzeau, Limoges

88100

AO Materdomini, Catanzaro

90146

"Casa di Cura La Maddalena", Palermo

94010

Centre Hospitalier Intercommunal, Créteil

98125

AOU Policlinico G. Martino, Messina

Unknown

Centre Hospitalier Universitaire D'Angers, Angers

Centre Hospitalier René Dubos, Cergy-Pontoise

Hôpital A. Mignot, Le Chesnay

Centre Hospitalier Du Mans, Le Mans

Centre Hospitalier Régional, Longjumeau

Centre Hospitalier de Meaux, Meaux

Centre Hospitalier de Mulhouse, Mulhouse

Centre Hospitalier, Périgueux

Centre Hospitalier de La Région D'Annecy, Pringy

Centre Hosiptalier Genéral de Roanne, Roanne

Institut de Cancérologie de La Loire, Saint-Priest-en-Jarez

ICO - H. Germans Trias i Pujol, Badalona

H.G.U. Alicante, Alicante

Hospital San Millan Y San Pedro, Logroño

H. 12 de Octubre, Madrid

H. Ramon y Cajal, Madrid

Clinica Rotger, Palma de Mallorca

00128

Istituti Fisioterapici Ospitalieri, Roma

00149

AO S.Camillo Forlanini, Roma

00161

"Università di Roma La Sapienza Az.Policlinico Umb.I°", Roma

07100

PO di SS.ma Annunziata, Sassari

03804

H. Virgen de los Lirios, Alcoy

03193

H. Torrevieja Salud, Torrevieja

08304

Hospital de Mataró, Mataró

07014

H. Son Dureta, Palma de Mallorca

08025

H. Santa Creu i Sant Pau, Barcelona

08028

Instituto Universitario Dexeus, Barcelona

08035

H.U.Vall D´Hebrón, Barcelona

08036

H. Clinic i Provincial, Barcelona

08243

H. Althaia, Barcelona

08907

H. Duran i Reynals-ICO, Barcelona

07198

H. Son Llàtzer, Palma de Mallorca

All Listed Sponsors
lead

Spanish Lung Cancer Group

OTHER

NCT00446225 - Phase III Study (Tarceva®) vs Chemotherapy to Treat Advanced Non-Small Cell Lung Cancer in Patients With Mutations in the TK Domain of EGFR | Biotech Hunter | Biotech Hunter