Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Docetaxel

Erlotinib Hydrochloride

Tubulin Modulators

Antimitotic Agents

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Erlotinib 150 mg/day per os until disease progression or unacceptable toxicity develops

Erlotinib

Docetaxel 75 mg/mq on day 1, every 21 days (3-weekly schedule) or Docetaxel 35 mg/mq 0n day 1,8 and 15 every 28 days (weekly schedule). _Until disease progression or unacceptable toxicity develops

Marina C Garassino, MD

Serena Girelli, Biologist

Giuseppe Nastasi, MD

Vittorio Ferrari, MD

Emanuela Vattemi, MD

Bruno Massidda, MD

Antonio Nuzzo, MD

Gianmaria Fiorentini, MD

Francesco Ferrau, MD

Luciano Isa, MD

Giambattista Roda, MD

Gianbattista Roda, MD

Ornella Gottardi, MD

Daniele Fagnani, MD

Sergio Palmeri, MD

Giorgio Cruciani, MD

Alessandra Zoboli, MD

Franco Spremberg, MD

Giuseppe Grimaldi, MD

Sergio Crispino, MD

Fausto Roila, MD

Claudio Verusio, MD

Andrea Bonetti, MD

Bruno Daniele, MD

Roberto Labianca, MD

Efisio Defraia, MD

Ida Colantonio, MD

Andrea Decensi, MD

Liberato Di Lullo, MD

Antonio Ardizzoia, MD

Gabriella Farina, MD

Maurizio Tomirotti, MD

Paolo Foa, MD

Maria Cristina Locatelli, MD

Maria Cristina Locatelli Locatelli, MD

Elena Piazza, MD

Oscar Alabiso, MD

Luigi Cavanna, MD

Salvatore Tumolo, MD

Ida Pavese, MD

Cora N Sternberg, MD

Enrico Cortesi, MD

Flavia Longo, MD

Maria Mauri, MD

Antonio Contu, MD

Antonio Farris, MD

Giuseppe Valmadre, MD

Alessandro Bertolini, MD

Alberto Scanni, MD

The aim of this study is to assess the superiority of docetaxel in comparison to erlotinib in second line in wild-type EGFR tumour patients.

Erlotinib is registered in all patients affected with NSCLC in second and subsequent lines with a small benefit on Overall Survival. Recent evidence suggest that patients with EGFR mutations have a clear benefit when they are treated with EGFR tyrosine kinase inhibitors, while the role of these drugs in wild-type EGFR patients, that are representing the large majority (about 85-90%), is still unclear and no properly planned trials assessed before this issue. Recently, indirect evidence on subgroup analyses on randomized trial suggest that chemotherapy might be superior to erlotinib in wild-type EGFR patients.

Moreover, several authors do not recommend the use of EGFR determined with immunohistochemistry (IHC) or FISH because they do not reproducibly predict outcome.

For these reasons the protocol was amended in May 2011 in a superiority trial of docetaxel versus erlotinib, while the first version was aimed to assess the interaction with biomarkers.

Tarceva Italian Lung Optimization tRial

Optimization of Erlotinib for the Treatment of Patients With Advanced Non Small Cell Lung Cancer: an Italian Randomized Trial

Mario Negri Institute for Pharmacological Research

Niguarda Hospital

Fatebenefratelli and Ophthalmic Hospital

Alberto Scanni MD

Spots Global Cancer Trial Database for egfr copy number