AzTrials
AzTrials

Non Small Cell Lung Cancer (NSCLC)Phase 3TAILORNCT00637910

Tarceva Italian Lung Optimization tRial

A Phase 3 study testing Erlotinib and Docetaxel in people with Non Small Cell Lung Cancer (NSCLC), run by Fatebenefratelli and Ophthalmic Hospital at 105 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non Small Cell Lung Cancer (NSCLC)
What is being tested?
Erlotinib and Docetaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
850 participants
Where
105 sitesItaly
Study dates
Nov 2007to Feb 2013
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 15Show fewer
  • 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)

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

105 sites in 1 country.

Marina C Garassino, MD contact

+39 0263632223

marina.garassino@fbf.milano.it

Serena Girelli, Biologist contact

+39 0263632223

datamanager@fbf.milano.it

105 sites in 1 country

Italy105 sites, 50 recruiting

  • S. Giovanni di Dio Hospital

    Agrigento, Agrigento, 92100

    Withdrawn

  • Pesenti-Fenaroli Hospital

    Alzano Lombardo, Bergamo, 24022

    Giuseppe Nastasi, MD, +39 0354177235, giuseppe.nastasi@bolognini.bg.it

    Giuseppe Nastasi, MD

    Recruiting

  • Ospedale San Donato

    Arezzo, 52100

    Terminated

  • Oncologia A.S.L. AV1

    Ariano Irpino, Avellino, 83031

    Terminated

  • Centro di Riferimento Oncologico

    Aviano, Pordenone, 33081

    Withdrawn

  • Azienda Ospedaliera Universitaria Consorziale Policlinico

    Bari, Bari, 70124

    Withdrawn

  • Fatebenefratelli Hospital

    Benevento, Benevento, 82100

    Terminated

  • G. Rummo Hospital

    Benevento, Benevento, 82100

    Bruno Daniele, MD, +39 082457724, bruno.daniele@ao-rummo.it

    Bruno Daniele, MD

    Recruiting

  • Ospedali Riuniti

    Bergamo, Bergamo, 24128

    Roberto Labianca, MD, +39 035 269724859, rlabian@tin.it

    Roberto Labianca, MD

    Recruiting

  • Ospedale centrale di Bolzano

    Bolzano, BZ, 39100

    Emanuela Vattemi, MD, +39 0471908952, emanuela.vattemi@asbz.it

    Emanuela Vattemi, MD

    Recruiting

  • Oncologia Medica Azienda Spedali Civili

    Brescia, BS, 25123

    Vittorio Ferrari, MD, +39 0303996583, bscivile@numerica.it

    Vittorio Ferrari, MD

    Recruiting

  • Pneumologia Azienda Spedali Civili

    Brescia, BS, 25123

    Vittorio Ferrari, MD, +39 0303996583, bscivile@numerica.it

    Vittorio Ferrari, MD

    Recruiting

  • Armando Businco Oncological Hospital

    Cagliari, Cagliari, 09100

    Efisio Defraia, MD, +39 0706095332, defraiae@alice.it

    Efisio Defraia, MD

    Recruiting

  • Ospedale S. Elia

    Caltanissetta, CL, 93100

    Terminated

  • Presidio Ospedaliero Cardarelli ASL 3

    Campobasso, Campobasso, 86100

    Terminated

  • Ospedale Civile di Casalpusterlengo

    Casalpusterlengo, Lodi, 26841

    Terminated

  • Ospedale Civile Ferrari

    Casarano, Lecce, 73042

    Terminated

  • Multimedia Santa Maria

    Castellanza, Varese, 21053

    Ornella Gottardi, MD, +39 0331476111, ornella.gottardi@multimedica.it

    Ornella Gottardi, MD

    Recruiting

  • Sant'Anna Hospital

    Como, Como, 22100

    Withdrawn

  • S. Sebastiano Hospital

    Correggio, Reggio Emilia, 42015

    Alessandra Zoboli, MD, +39 0522 630111, zobolia@ausl.re.it

    Alessandra Zoboli, MD

    Recruiting

  • Mariano Santo Hospital

    Cosenza, Cosenza, 87100

    Withdrawn

  • Ospedale Maggiore di Crema

    Crema, Crema, 26013

    Terminated

  • S. Croce e Carle Hospital

    Cuneo, Cuneo, 12100

    Ida Colantonio, MD, +39 0171616739, i.colantonio@libero.it

    Ida Colantonio, MD

    Recruiting

  • Istituto Toscano Tumori Ospedale S. Giuseppe Antica Sede

    Empoli, Firenze, 50053

    Gianmaria Fiorentini, MD, +39 0571702284, oncologiaempoli@usl11.toscana.it

    Gianmaria Fiorentini, MD

    Recruiting

  • Fabriano Hospital

    Fabriano, Ancona, 60044

    Withdrawn

  • A.O.U. S. Anna

    Ferrara, 44100

    Terminated

  • Azienda Ospedaliero Universitaria Careggi

    Florence, Firenze, 50130

    Terminated

  • A.O.U. Careggi

    Florence, 50130

    Terminated

  • Galliera Hospital

    Genova, Genova, 16128

    Andrea Decensi, MD, +39 010 5634501, andrea.decensi@galliera.it

    Andrea Decensi, MD

    Recruiting

  • A.O. San Martino

    Genova, 16100

    Terminated

  • Azienda Ospedaliera Melegnano- P.O. Gorgonzola

    Gorgonzola, Milano, 20069

    Luciano Isa, MD, +39 0295707207, luciano.isa@tiscalinet.it

    Luciano Isa, MD

    Recruiting

  • San Leonardo Hospital

    Gragnano, Napoli, 80054

    Terminated

  • Ospedale Santa Barbara

    Iglesias, Carbonia Iglesias, 09016

    Terminated

  • F. Veneziale Hospital

    Isernia, Isernia, 86170

    Liberato Di Lullo, MD, +39 0865442212, oncologia.is@infinito.it

    Liberato Di Lullo, MD

    Recruiting

  • Renzetti Hospital

    Lanciano, Chieti, 66034

    Antonio Nuzzo, MD, +39 0872706220, nuzzo@oncologialanciano.it

    Antonio Nuzzo, MD

    Recruiting

  • Ospedale S. Maria Goretti

    Latina, LT, 04100

    Terminated

  • Azienda Ospedaliera di Lecco

    Lecco, Lecco, 23900

    Antonio Ardizzoia, MD, +39 0341489900, antonio.ardizoia@tin.it

    Antonio Ardizzoia, MD

    Recruiting

  • Ospedale Mater Salutis

    Legnago, Verona, 37045

    Andrea Bonetti, MD, 0039.0442632418, andrea.bonetti@aulsslegnago.it

    Andrea Bonetti, MD

    Recruiting

  • Legnano Hospital

    Legnano, Milano, 20025

    Giambattista Roda, MD, +39 0331449306, laelena75@hotmail.com

    Gianbattista Roda, MD

    Recruiting

  • Umberto I Hospital

    Lugo, Ravenna, 48022

    Giorgio Cruciani, MD, +39 0545214081, g.cruciani@ausl.ra.it

    Giorgio Cruciani, MD

    Recruiting

  • Ospedale Civile di Legnano -Presidio di Magenta

    Magenta, Milano, 20013

    Withdrawn

  • Umberto I Hospital

    Mestre, Venezia, 30174

    Terminated

  • Fatebenefratelli and Ophthalmic Hospital

    Milan, Milano, 20121

    Gabriella Farina, MD, +39 0263632223, gabriella.farina@fbf.milano.it

    Marina C Garassino, MD, +39 0263632223, marina.garassino@fbf.milano.it

    Recruiting

  • Fondazione Ospedale Maggiore Policlinico - Mangiagalli e Regina Elena

    Milan, Milano, 20122

    Maurizio Tomirotti, MD, +39 0255034670, mtomirotti@policlinico.mi.it

    Maurizio Tomirotti, MD

    Recruiting

  • San Paolo Hospital

    Milan, Milano, 20142

    Paolo Foa, MD, +39 0250323085, paolo.foa@unimi.it

    Paolo Foa, MD

    Recruiting

  • San Carlo Borromeo Hospital

    Milan, Milano, 20153

    Maria Cristina Locatelli, MD, +39 0240222270, locatellimc@hotmail.com;

    Maria Cristina Locatelli Locatelli, MD

    Recruiting

  • Azienda Ospedaliera Luigi Sacco Polo Universitario

    Milan, Milano, 20157

    Elena Piazza, MD, +39 0239042493, e.piazza@hsacco.it

    Elena Piazza, MD

    Recruiting

  • Monfalcone Hospital

    Monfalcone, Gorizia, 34074

    Terminated

  • Policlinico Universitario di Monserrato

    Monserrato, Cagliari, 09042

    Bruno Massidda, MD, +39 07051096208, masbru@pacs.unica.it

    Bruno Massidda, MD

    Recruiting

  • Ospedale Valdichiana "Nottola"

    Montepulciano, Siena, 53045

    Sergio Crispino, MD, +39 0578713111, dip.oncologico@usl7.toscana.it

    Sergio Crispino, MD

    Recruiting

  • San Gerardo Hospital

    Monza, Milano, 20052

    Withdrawn

  • Cardarelli Hospital

    Naples, Napoli, 80131

    Terminated

  • D. Cotugno Hospital

    Naples, Napoli, 80131

    Terminated

  • San Gennaro Hospital - ASL NA 1

    Naples, Napoli, 80136

    Terminated

  • A.O. Monaldi

    Naples, 80131

    Terminated

  • ASL SA1 -P.O. Umberto I

    Nocera Inferiore, Salerno, 84014

    Giuseppe Grimaldi, MD, +39 0819213331, gsgrimaldi@fastwebnet.it

    Giuseppe Grimaldi, MD

    Recruiting

  • Ospedale Maggiore della Carità

    Novara, Novara, 28100

    Oscar Alabiso, MD, +39 03213733984, alabiso@med.unipmn.it

    Oscar Alabiso, MD

    Recruiting

  • Azienda Ospedaliera Universitaria Presidio "Paolo Giaccone"

    Palermo, Palermo, 90127

    Terminated

  • Presidio Ospedaliero "M. Ascoli" ARNAS Civico

    Palermo, Palermo, 90127

    Terminated

  • Centro Oncologico "La Maddalena"

    Palermo, Palermo, 90146

    Terminated

  • Policlinico Universitario Palermo

    Palermo, PA, 90127

    Sergio Palmeri, MD, +39 0916552506, sergiopalmeri@alice.it

    Sergio Palmeri, MD

    Recruiting

  • San Francesco Hospital

    Paola, Cosenza, 87027

    Terminated

  • San Massimo Hospital

    Penne, Pescara, 65017

    Terminated

  • S. Maria della Misericordia Hospital

    Perugia, Perugia, 06156

    Terminated

  • Piacenza Hospital

    Piacenza, Piacenza, 29100

    Luigi Cavanna, MD, +39 0523302697, l.cavanna@ausl.pc.it

    Luigi Cavanna, MD

    Recruiting

  • Ospedale Valdelsa "Campostaggia"

    Poggibonsi, Siena, 53036

    Sergio Crispino, MD, +39 0577586927, s.crispino@usl7.toscana.it

    Sergio Crispino, MD

    Recruiting

  • S. Maria degli Angeli Hospital

    Pordenone, Pordenone, 33170

    Salvatore Tumolo, MD, +39 0434399464, salvatore.tumolo@aopn.fvg.it

    Salvatore Tumolo, MD

    Recruiting

  • Ospedale Civile Santa Maria delle Croci

    Ravenna, 48100

    Giorgio Cruciani, MD, 0039.054428530, g.cruciani@ausl.ra.it

    Giorgio Cruciani, MD

    Recruiting

  • Arcispedale S. Maria Nuova

    Reggio Emilia, Reggio Emilia, 42100

    Withdrawn

  • Rho Hospital - Azienda Ospedaliera Salvini-Garbagnate

    Rho, Milano, 20017

    Terminated

  • Pneumologia Oncologica II-San Camillo Forlanini Hospital

    Roma, Roma, 00149

    Terminated

  • Oncologia Medica-San Camillo Forlanini Hopsital

    Roma, Roma, 00152

    Cora N Sternberg, MD, +39 0658704317, csternberg@scamilloforlanini.rm.it

    Cora N Sternberg, MD

    Recruiting

  • Università Campus Bio-Medico

    Roma, Roma, 00155

    Terminated

  • Policlinico Umberto I

    Roma, Roma, 00161

    Enrico Cortesi, MD, +39 064462982, enricocortesi@uniroma1.it

    Enrico Cortesi, MD

    Recruiting

  • Policlinico Umberto I

    Roma, Roma, 00161

    Flavia Longo, MD, +39 0649970273, flavia.longo@uniroma1.it

    Flavia Longo, MD

    Recruiting

  • S. Giovanni - Addolorata Hospital

    Roma, Roma, 00184

    Maria Mauri, MD, +39 0677052929, mariella.mauri@libero.it

    Maria Mauri, MD

    Recruiting

  • Ospedale San Pietro Fatebenefratelli

    Roma, 00100

    Ida Pavese, MD, 0039.0633582831, idapavese@yahoo.it

    Ida Pavese, MD

    Recruiting

  • Azienda Ospedaliera S. Giovanni di Dio e Ruggi d'Aragona

    Salerno, Salerno, 84122

    Terminated

  • Ospedale Civile di Saluzzo Savigliano

    Saluzzo, Cuneo, 12037

    Withdrawn

  • Policlinico San Donato

    San Donato Milanese, Milano, 20097

    Terminated

  • B. Eustachio Hospital

    San Severino Marche, Macerata, 62027

    Terminated

  • Azienda Ospedaliera Busto Arsizio

    Saronno, Varese, 21047

    Claudio Verusio, MD, +39 029613576, cverusio@aobusto.it

    Claudio Verusio, MD

    Recruiting

  • Ospedale Civile SS. Annunziata

    Sassari, Sassari, 07100

    Antonio Contu, MD, +39 0792061638, antoncontu@tiscali.it

    Antonio Contu, MD

    Recruiting

  • Universita' di Sassari Oncologia Medica

    Sassari, 07100

    Antonio Farris, MD, 0039.079228382, afarris@uniss.it

    Antonio Farris, MD

    Recruiting

  • Ospedale di Scandiano

    Scandiano, Reggio Emilia, 42019

    Terminated

  • Ospedale Civili Riuniti Giovanni Paolo II

    Sciacca, Agrigento, 92100

    Terminated

  • IRCCS Multimedica

    Sesto San Giovanni, Milano, 20099

    Ornella Gottardi, MD, +39 02 24209498, ornella.gottardi@multimedica.it

    Ornella Gottardi, MD

    Recruiting

  • Ospedale Civile di Siderno - ASL n°9 Locri

    Siderno, Reggio Calabria, 89946

    Terminated

  • Sondrio Hospital-Azienda Ospedaliera Valtellina e Valchiavenna

    Sondrio, Sondrio, 23100

    Alessandro Bertolini, MD, +39 0342521594, abertolini@tiscalinet.it

    Alessandro Bertolini, MD

    Recruiting

  • Ospedale Morelli

    Sondrio, 23035

    Giuseppe Valmadre, MD, 0039.0342808322, giuseppe.valmadre@aovv.it

    Giuseppe Valmadre, MD

    Recruiting

  • Ospedale di Vipiteno

    Sterzing, Bolzano, 39049

    Terminated

  • San Vincenzo Hospital

    Taormina, Messina, 98039

    Francesco Ferrau, MD, +39 0942579322331, omtaormina@tin.it

    Francesco Ferrau, MD

    Recruiting

  • Ospedale di Terni

    Terni, TR, 05100

    Fausto Roila, MD, +39 0744205584, roila.fausto@libero.it

    Fausto Roila, MD

    Recruiting

  • S. Giovanni Evangelista Hospital

    Tivoli, Roma, 00019

    Franco Spremberg, MD, +39 07743164353, franco.spremberg@libero.it

    Franco Spremberg, MD

    Recruiting

  • A.O.U. San Giovanni Battista Molinette

    Torino, 10134

    Libero Ciuffreda, MD, 0039.0116334250, lciuffreda@molinette.piemonte.it

    Libero Ciuffreda, MD

    Recruiting

  • Ospedali Riuniti Umberto I - Lancisi - Salesi

    Torrette, Ancona, 60020

    Terminated

  • Presidio Ospedaliero San Luca

    Vallo della Lucania, Salerno, 84078

    Terminated

  • Ospedale di Circolo

    Varese, Varese, 21100

    Terminated

  • SS. Giovanni e Paolo Hospital

    Venezia, Venezia, 30122

    Terminated

  • Ospedale Policlinico G.B. Rossi

    Verona, VR, 37134

    Terminated

  • San Bartolo Hospital

    Vicenza, Vicenza, 36100

    Withdrawn

  • Ospedale Civile Vigevano

    Vigevano, Pavia, 27029

    Terminated

  • Ospedale Civile di Vimercate

    Vimercate, Milano, 20059

    Daniele Fagnani, MD, +39 0362383230, daniele.fagnani@libero.it

    Daniele Fagnani, MD

    Recruiting

  • Belcolle Hospital

    Viterbo, Viterbo, 01100

    Luca Moscetti, MD, +39 0761339040, l.moscetti@asl.vt.it

    Luca Moscetti, MD

    Recruiting

  • Vizzolo Predabissi Hospital

    Vizzolo Predabissi, Milano, 20070

    Terminated

Other trials in Italy

About this study

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

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.

Read the 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.

Being tested
Erlotinib, Docetaxel
Keywords
Advanced NSCLC, EGFR, EGFR copy number, Kras mutations, EGRF mutations, Docetaxel, Erlotinib, Polymorphisms
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ErlotinibDrug

    Also called Tarceva

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

  • DocetaxelDrug

    Also called Taxotere

    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

Study groups in NCT00637910
Study groupRoleWhat they receive
Erlotinib ArmExperimentalNot described
Receives: Drug: Erlotinib
Docetaxel ArmActive comparatorNot described
Receives: Drug: Docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival

    Measured: 12 months after the last patient is randomized

Secondary outcomes (6)

  1. Progression Free Survival

    Measured: with 4 years and 12 months after the last patient is randomized

  2. Response assessed with RECIST criteria

    Measured: within 4 years

  3. Quality of Life assessed with QLQ-C30 and QLQ-LC13 questionnaires

    Measured: within 4 years

  4. Toxicity, graded according to the NCI-CTAE version 3.0

    Measured: within 4 years

  5. Frequency and nature of serious adverse reactions

    Measured: within 4 years

  6. Premature withdrawals

    Measured: within 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2008 (estimated)
  2. Study startNov 2007
  3. Primary completionFeb 2012 (estimated)
  4. Study completionFeb 2013 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
850 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00637910
Sponsor's protocol ID
FARM6F5JER
Other IDs
2007-004786-17
Acronym
TAILOR
Status last verified
Feb 2012
First submitted
12 Mar 2008
Last updated
24 Feb 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • Greenlee RT, Hill-Harmon MB, Murray T, Thun M. Cancer statistics, 2001. CA Cancer J Clin. 2001 Jan-Feb;51(1):15-36. doi: 10.3322/canjclin.51.1.15.

    PubMed 11577478

  • Schiller JH, Harrington D, Belani CP, Langer C, Sandler A, Krook J, Zhu J, Johnson DH; Eastern Cooperative Oncology Group. Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer. N Engl J Med. 2002 Jan 10;346(2):92-8. doi: 10.1056/NEJMoa011954.

    PubMed 11784875

  • Shepherd FA, Dancey J, Ramlau R, Mattson K, Gralla R, O'Rourke M, Levitan N, Gressot L, Vincent M, Burkes R, Coughlin S, Kim Y, Berille J. Prospective randomized trial of docetaxel versus best supportive care in patients with non-small-cell lung cancer previously treated with platinum-based chemotherapy. J Clin Oncol. 2000 May;18(10):2095-103. doi: 10.1200/JCO.2000.18.10.2095.

    PubMed 10811675

  • Schuette W, Nagel S, Blankenburg T, Lautenschlaeger C, Hans K, Schmidt EW, Dittrich I, Schweisfurth H, von Weikersthal LF, Raghavachar A, Reissig A, Serke M. Phase III study of second-line chemotherapy for advanced non-small-cell lung cancer with weekly compared with 3-weekly docetaxel. J Clin Oncol. 2005 Nov 20;23(33):8389-95. doi: 10.1200/JCO.2005.02.3739.

    PubMed 16293869

  • Hanna N, Shepherd FA, Fossella FV, Pereira JR, De Marinis F, von Pawel J, Gatzemeier U, Tsao TC, Pless M, Muller T, Lim HL, Desch C, Szondy K, Gervais R, Shaharyar, Manegold C, Paul S, Paoletti P, Einhorn L, Bunn PA Jr. Randomized phase III trial of pemetrexed versus docetaxel in patients with non-small-cell lung cancer previously treated with chemotherapy. J Clin Oncol. 2004 May 1;22(9):1589-97. doi: 10.1200/JCO.2004.08.163.

    PubMed 15117980

  • Shepherd FA, Rodrigues Pereira J, Ciuleanu T, Tan EH, Hirsh V, Thongprasert S, Campos D, Maoleekoonpiroj S, Smylie M, Martins R, van Kooten M, Dediu M, Findlay B, Tu D, Johnston D, Bezjak A, Clark G, Santabarbara P, Seymour L; National Cancer Institute of Canada Clinical Trials Group. Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med. 2005 Jul 14;353(2):123-32. doi: 10.1056/NEJMoa050753.

    PubMed 16014882

  • Herbst RS, Prager D, Hermann R, Fehrenbacher L, Johnson BE, Sandler A, Kris MG, Tran HT, Klein P, Li X, Ramies D, Johnson DH, Miller VA; TRIBUTE Investigator Group. TRIBUTE: a phase III trial of erlotinib hydrochloride (OSI-774) combined with carboplatin and paclitaxel chemotherapy in advanced non-small-cell lung cancer. J Clin Oncol. 2005 Sep 1;23(25):5892-9. doi: 10.1200/JCO.2005.02.840. Epub 2005 Jul 25.

    PubMed 16043829

  • Gatzemeier U, Pluzanska A, Szczesna A, Kaukel E, Roubec J, De Rosa F, Milanowski J, Karnicka-Mlodkowski H, Pesek M, Serwatowski P, Ramlau R, Janaskova T, Vansteenkiste J, Strausz J, Manikhas GM, Von Pawel J. Phase III study of erlotinib in combination with cisplatin and gemcitabine in advanced non-small-cell lung cancer: the Tarceva Lung Cancer Investigation Trial. J Clin Oncol. 2007 Apr 20;25(12):1545-52. doi: 10.1200/JCO.2005.05.1474.

    PubMed 17442998

  • Marchetti A, Martella C, Felicioni L, Barassi F, Salvatore S, Chella A, Camplese PP, Iarussi T, Mucilli F, Mezzetti A, Cuccurullo F, Sacco R, Buttitta F. EGFR mutations in non-small-cell lung cancer: analysis of a large series of cases and development of a rapid and sensitive method for diagnostic screening with potential implications on pharmacologic treatment. J Clin Oncol. 2005 Feb 1;23(4):857-65. doi: 10.1200/JCO.2005.08.043.

    PubMed 15681531

  • Sequist LV, Joshi VA, Janne PA, Muzikansky A, Fidias P, Meyerson M, Haber DA, Kucherlapati R, Johnson BE, Lynch TJ. Response to treatment and survival of patients with non-small cell lung cancer undergoing somatic EGFR mutation testing. Oncologist. 2007 Jan;12(1):90-8. doi: 10.1634/theoncologist.12-1-90.

    PubMed 17285735

  • Taron M, Ichinose Y, Rosell R, Mok T, Massuti B, Zamora L, Mate JL, Manegold C, Ono M, Queralt C, Jahan T, Sanchez JJ, Sanchez-Ronco M, Hsue V, Jablons D, Sanchez JM, Moran T. Activating mutations in the tyrosine kinase domain of the epidermal growth factor receptor are associated with improved survival in gefitinib-treated chemorefractory lung adenocarcinomas. Clin Cancer Res. 2005 Aug 15;11(16):5878-85. doi: 10.1158/1078-0432.CCR-04-2618.

    PubMed 16115929

  • van Zandwijk N, Mathy A, Boerrigter L, Ruijter H, Tielen I, de Jong D, Baas P, Burgers S, Nederlof P. EGFR and KRAS mutations as criteria for treatment with tyrosine kinase inhibitors: retro- and prospective observations in non-small-cell lung cancer. Ann Oncol. 2007 Jan;18(1):99-103. doi: 10.1093/annonc/mdl323. Epub 2006 Oct 23.

    PubMed 17060486

  • Cappuzzo F, Hirsch FR, Rossi E, Bartolini S, Ceresoli GL, Bemis L, Haney J, Witta S, Danenberg K, Domenichini I, Ludovini V, Magrini E, Gregorc V, Doglioni C, Sidoni A, Tonato M, Franklin WA, Crino L, Bunn PA Jr, Varella-Garcia M. Epidermal growth factor receptor gene and protein and gefitinib sensitivity in non-small-cell lung cancer. J Natl Cancer Inst. 2005 May 4;97(9):643-55. doi: 10.1093/jnci/dji112.

    PubMed 15870435

  • Bell DW, Lynch TJ, Haserlat SM, Harris PL, Okimoto RA, Brannigan BW, Sgroi DC, Muir B, Riemenschneider MJ, Iacona RB, Krebs AD, Johnson DH, Giaccone G, Herbst RS, Manegold C, Fukuoka M, Kris MG, Baselga J, Ochs JS, Haber DA. Epidermal growth factor receptor mutations and gene amplification in non-small-cell lung cancer: molecular analysis of the IDEAL/INTACT gefitinib trials. J Clin Oncol. 2005 Nov 1;23(31):8081-92. doi: 10.1200/JCO.2005.02.7078. Epub 2005 Oct 3.

    PubMed 16204011

  • Hirsch FR, Varella-Garcia M, Bunn PA Jr, Franklin WA, Dziadziuszko R, Thatcher N, Chang A, Parikh P, Pereira JR, Ciuleanu T, von Pawel J, Watkins C, Flannery A, Ellison G, Donald E, Knight L, Parums D, Botwood N, Holloway B. Molecular predictors of outcome with gefitinib in a phase III placebo-controlled study in advanced non-small-cell lung cancer. J Clin Oncol. 2006 Nov 1;24(31):5034-42. doi: 10.1200/JCO.2006.06.3958.

    PubMed 17075123

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Erlotinib and Docetaxel in people with Non Small Cell Lung Cancer (NSCLC), run by Fatebenefratelli and Ophthalmic Hospital at 105 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 105 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Marina C Garassino, MD (+39 0263632223, marina.garassino@fbf.milano.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: 12 months after the last patient is randomized). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00637910, which also lists 35 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2012.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in