Tarceva Italian Lung Optimization tRial
- Registration Number
- NCT00637910
- Lead Sponsor
- Fatebenefratelli and Ophthalmic Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 850
- Age 18 years or older
- Histological or cytological confirmation of NSCLC (may be from initial diagnosis of NSCLC or subsequent biopsy). Only patients with available tissue samples may be included in the study
- Absence of EGFR mutations of exons 19 or 21 (randomization)
- Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy
- One prior platinum-based at adequate doses and taxane free regimen
- Measurable (uni-dimensional) disease by RECIST in a lesion not previously irradiated or non-measurable disease
- ECOG-PS 0-2
- ANC greater than 1.5 x 109/L and platelets greater than 100 x 109/L
- Bilirubin level either normal or <1.5xULN
- AST (SGOT) and ALT (SGPT) <2.5xULN (≤5 x ULN if liver metastases are present)
- Serum creatinine <1.5xULN
- Effective contraception for both, male and female pts, if the risk of conception exists
- Recovery from all acute toxicities of prior therapies
- Provision of written informed consent to the analysis of biological markers (registration)
- Provision of written informed consent to enter the randomized part of the study (randomization)
- Prior therapy with an experimental agent whose primary mechanism of action is inhibition of EGFR or its associated tyrosine kinase
- Prior chemotherapy with taxanes
- Newly diagnosed CNS metastases that have not yet been treated with surgery and/or radiation. Pts with previously diagnosed and treated CNS metastases or spinal cord compression may be considered if they have evidence of clinically SD (no steroid therapy or steroid dose being tapered) for at least 28 daysLess than 14 days since completion of prior radiotherapy or persistence of any radiotherapy related toxicity
- Any unresolved chronic toxicity from previous anticancer therapy that, in the opinion of the investigator, makes it inappropriate for the patient to be enrolled in the study Known severe hypersensitivity to erlotinib or any of the excipients of this product
- Known hypersensitivity to docetaxel, polysorbate 80 or other drugs formulated with polysorbate 80, or any of the excipients of docetaxel
- Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
- Unable to swallow tablets
- Any evidence of clinically active interstitial lung disease (patients with chronic, stable, radiographic changes who are asymptomatic or patients with uncomplicated progressive lymphangitic carcinomatosis need not be excluded)
- As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic or renal disease)
- As judged by the investigator, any inflammatory changes of the surface of the eye
- Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Erlotinib Arm Erlotinib - Docetaxel Arm Docetaxel -
- Primary Outcome Measures
Name Time Method Overall Survival 12 months after the last patient is randomized
- Secondary Outcome Measures
Name Time Method Progression Free Survival with 4 years and 12 months after the last patient is randomized Premature withdrawals within 4 years Response assessed with RECIST criteria within 4 years Quality of Life assessed with QLQ-C30 and QLQ-LC13 questionnaires within 4 years Toxicity, graded according to the NCI-CTAE version 3.0 within 4 years Frequency and nature of serious adverse reactions within 4 years
Trial Locations
- Locations (103)
D. Cotugno Hospital
🇮🇹Napoli, Italy
Ospedale di Circolo
🇮🇹Varese, Italy
Belcolle Hospital
🇮🇹Viterbo, Italy
Ospedale Santa Barbara
🇮🇹Iglesias, Carbonia Iglesias, Italy
Renzetti Hospital
🇮🇹Lanciano, Chieti, Italy
San Francesco Hospital
🇮🇹Paola, Cosenza, Italy
Monfalcone Hospital
🇮🇹Monfalcone, Gorizia, Italy
Ospedale Civili Riuniti Giovanni Paolo II
🇮🇹Sciacca, Agrigento, Italy
Fabriano Hospital
🇮🇹Fabriano, Ancona, Italy
Ospedali Riuniti Umberto I - Lancisi - Salesi
🇮🇹Torrette, Ancona, Italy
Oncologia A.S.L. AV1
🇮🇹Ariano Irpino, Avellino, Italy
Ospedale di Vipiteno
🇮🇹Vipiteno, Bolzano, Italy
Ospedale centrale di Bolzano
🇮🇹Bolzano, BZ, Italy
Policlinico Universitario di Monserrato
🇮🇹Monserrato, Cagliari, Italy
Istituto Toscano Tumori Ospedale S. Giuseppe Antica Sede
🇮🇹Empoli, Firenze, Italy
Rho Hospital - Azienda Ospedaliera Salvini-Garbagnate
🇮🇹Rho, Milano, Italy
Policlinico San Donato
🇮🇹San Donato Milanese, Milano, Italy
IRCCS Multimedica
🇮🇹Sesto San Giovanni, Milano, Italy
Oncologia Medica Azienda Spedali Civili
🇮🇹Brescia, BS, Italy
Azienda Ospedaliera Melegnano- P.O. Gorgonzola
🇮🇹Gorgonzola, Milano, Italy
Ospedale Civile Ferrari
🇮🇹Casarano, Lecce, Italy
Ospedale S. Maria Goretti
🇮🇹Latina, LT, Italy
Ospedale Civile di Casalpusterlengo
🇮🇹Casalpusterlengo, Lodi, Italy
B. Eustachio Hospital
🇮🇹San Severino Marche, Macerata, Italy
San Vincenzo Hospital
🇮🇹Taormina, Messina, Italy
Ospedale Civile di Vimercate
🇮🇹Vimercate, Milano, Italy
Legnano Hospital
🇮🇹Legnano, Milano, Italy
San Gerardo Hospital
🇮🇹Monza, Milano, Italy
Ospedale Civile di Siderno - ASL n°9 Locri
🇮🇹Siderno, Reggio Calabria, Italy
Azienda Ospedaliera di Lecco
🇮🇹Lecco, Italy
Fatebenefratelli and Ophthalmic Hospital
🇮🇹Milano, Italy
San Paolo Hospital
🇮🇹Milano, Italy
Ospedale Maggiore della Carità
🇮🇹Novara, Italy
Azienda Ospedaliera Universitaria Presidio "Paolo Giaccone"
🇮🇹Palermo, Italy
Presidio Ospedaliero "M. Ascoli" ARNAS Civico
🇮🇹Palermo, Italy
Sondrio Hospital-Azienda Ospedaliera Valtellina e Valchiavenna
🇮🇹Sondrio, Italy
Arcispedale S. Maria Nuova
🇮🇹Reggio Emilia, Italy
SS. Giovanni e Paolo Hospital
🇮🇹Venezia, Italy
Pesenti-Fenaroli Hospital
🇮🇹Alzano Lombardo, Bergamo, Italy
S. Sebastiano Hospital
🇮🇹Correggio, Reggio Emilia, Italy
Ospedale Civile di Saluzzo Savigliano
🇮🇹Saluzzo, Cuneo, Italy
Ospedale Mater Salutis
🇮🇹Legnago, Verona, Italy
Pneumologia Azienda Spedali Civili
🇮🇹Brescia, BS, Italy
Ospedale S. Elia
🇮🇹Caltanissetta, CL, Italy
Ospedale Civile di Legnano -Presidio di Magenta
🇮🇹Magenta, Milano, Italy
Vizzolo Predabissi Hospital
🇮🇹Vizzolo Predabissi, Milano, Italy
San Leonardo Hospital
🇮🇹Gragnano, Napoli, Italy
Ospedale Civile Vigevano
🇮🇹Vigevano, Pavia, Italy
San Massimo Hospital
🇮🇹Penne, Pescara, Italy
Umberto I Hospital
🇮🇹Mestre, Venezia, Italy
Policlinico Universitario Palermo
🇮🇹Palermo, PA, Italy
Centro di Riferimento Oncologico
🇮🇹Aviano, Pordenone, Italy
Ospedale di Scandiano
🇮🇹Scandiano, Reggio Emilia, Italy
Presidio Ospedaliero San Luca
🇮🇹Vallo della Lucania, Salerno, Italy
Ospedale Valdelsa "Campostaggia"
🇮🇹Poggibonsi, Siena, Italy
S. Giovanni Evangelista Hospital
🇮🇹Tivoli, Roma, Italy
Ospedale Valdichiana "Nottola"
🇮🇹Montepulciano, Siena, Italy
ASL SA1 -P.O. Umberto I
🇮🇹Nocera Inferiore, Salerno, Italy
Ospedale di Terni
🇮🇹Terni, TR, Italy
Azienda Ospedaliera Busto Arsizio
🇮🇹Saronno, Varese, Italy
Ospedale Policlinico G.B. Rossi
🇮🇹Verona, VR, Italy
Multimedia Santa Maria
🇮🇹Castellanza, Varese, Italy
S. Giovanni di Dio Hospital
🇮🇹Agrigento, Italy
Azienda Ospedaliera Universitaria Consorziale Policlinico
🇮🇹Bari, Italy
Ospedale San Donato
🇮🇹Arezzo, Italy
Fatebenefratelli Hospital
🇮🇹Benevento, Italy
G. Rummo Hospital
🇮🇹Benevento, Italy
Ospedali Riuniti
🇮🇹Bergamo, Italy
Presidio Ospedaliero Cardarelli ASL 3
🇮🇹Campobasso, Italy
Sant'Anna Hospital
🇮🇹Como, Italy
Armando Businco Oncological Hospital
🇮🇹Cagliari, Italy
Mariano Santo Hospital
🇮🇹Cosenza, Italy
Ospedale Maggiore di Crema
🇮🇹Crema, Italy
S. Croce e Carle Hospital
🇮🇹Cuneo, Italy
Galliera Hospital
🇮🇹Genova, Italy
Azienda Ospedaliero Universitaria Careggi
🇮🇹Firenze, Italy
A.O.U. S. Anna
🇮🇹Ferrara, Italy
A.O.U. Careggi
🇮🇹Firenze, Italy
A.O. San Martino
🇮🇹Genova, Italy
F. Veneziale Hospital
🇮🇹Isernia, Italy
Fondazione Ospedale Maggiore Policlinico - Mangiagalli e Regina Elena
🇮🇹Milano, Italy
A.O. Monaldi
🇮🇹Napoli, Italy
Cardarelli Hospital
🇮🇹Napoli, Italy
San Carlo Borromeo Hospital
🇮🇹Milano, Italy
Azienda Ospedaliera Luigi Sacco Polo Universitario
🇮🇹Milano, Italy
San Gennaro Hospital - ASL NA 1
🇮🇹Napoli, Italy
Centro Oncologico "La Maddalena"
🇮🇹Palermo, Italy
Piacenza Hospital
🇮🇹Piacenza, Italy
S. Maria della Misericordia Hospital
🇮🇹Perugia, Italy
S. Maria degli Angeli Hospital
🇮🇹Pordenone, Italy
Oncologia Medica-San Camillo Forlanini Hopsital
🇮🇹Roma, Italy
Università Campus Bio-Medico
🇮🇹Roma, Italy
Ospedale San Pietro Fatebenefratelli
🇮🇹Roma, Italy
Pneumologia Oncologica II-San Camillo Forlanini Hospital
🇮🇹Roma, Italy
Ospedale Civile Santa Maria delle Croci
🇮🇹Ravenna, Italy
Azienda Ospedaliera S. Giovanni di Dio e Ruggi d'Aragona
🇮🇹Salerno, Italy
Universita' di Sassari Oncologia Medica
🇮🇹Sassari, Italy
S. Giovanni - Addolorata Hospital
🇮🇹Roma, Italy
Ospedale Civile SS. Annunziata
🇮🇹Sassari, Italy
Policlinico Umberto I
🇮🇹Roma, Italy
Ospedale Morelli
🇮🇹Sondrio, Italy
A.O.U. San Giovanni Battista Molinette
🇮🇹Torino, Italy
San Bartolo Hospital
🇮🇹Vicenza, Italy