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Non-Small Cell Lung CancerPhase 3EURTACNCT00446225

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

A Phase 3 study testing Erlotinib, Carboplatin and Gemcitabin in people with Non-Small Cell Lung Cancer, run by Spanish Lung Cancer Group at 76 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

A Phase III, multicenter, open-label, randomized trial of Erlotinib (Tarceva®) versus chemotherapy in patients with advanced NSCLC with mutations in the Tyrosine Kinase (TK) domain of the EGFR. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
Erlotinib, Carboplatin and Gemcitabin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
174 participants
Where
76 sitesin 3 countries
Study dates
15 Feb 2007to Dec 2012
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Informed consent
  • Histologically confirmed diagnosis of NSCLC, non epidermoid, stage IV or IIIB with pleural effusion, or N3 tumours not candidate for thoracic radiotherapy, harbouring deletions in the exon 19 or mutation in the exon 21 in the TK of the EGFR.
  • Either measurable or evaluable disease.
  • Age > 18 years.
  • ECOG performance status < 2.
  • Adequate bone marrow function
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  • Adequate renal function
  • Adequate hepatic function
  • Patients must be accessible for treatment and follow-up.
  • Patients capable of following an adequate therapeutic compliance
  • Women of child bearing potential: negative pregnancy test.
  • Patients of both genders at a fertile age, including those women having their last menstruation within the two previous years, must follow effective contraceptive measures.
  • Ability to swallow.
  • Patients with asymptomatic brain metastasis and stable with medical treatment will be eligible for the study. Patients having received radiotherapy for their brain metastasis prior to the systemic treatment for the NSCLC will be also eligible.
  • Absence of gastrointestinal tract problems

Who cannot join

  • Pregnant or lactating women.
  • Women of child bearing potential having a positive pregnancy test in the basal visit or not accomplishing the test.
  • Patients of both genders sexually active (at a fertile age) not following contraceptive measures during the study.
  • Prior chemotherapy for metastatic disease. Both prior neoadjuvant and adjuvant chemotherapy allowed provided that completed ≥ 6 months before entering the study.
  • Prior treatment with EGFR targeted therapies.
  • Patients may have received radiotherapy, provided that the irradiated lesion is not the only evaluable lesion for response and completed before entering the study.
Show all 22Show fewer
  • Prior experimental pharmacological agent within the 3 weeks prior to the inclusion of the study.
  • Any significant ophthalmologic impairment of the eye surface. Use of contact lenses is not recommended.
  • Pre-existing motor or sensorial neurotoxicity grade > 2, according to the NCI-CTC criteria.
  • Evidence of spinal cord compression.
  • Inability to take oral medication and surgical procedures affecting the absorption or implying intravenous or parenteral feeding.
  • Any other severe disease or clinical conditions, as, but not only:
  • Unstable cardiopathy despite treatment, myocardial infarction within the 6 months before entering the study
  • History of significant neurological or psychiatric disorders, including dementia and epileptic seizures.
  • Uncontrolled active infection.
  • Uncontrolled peptic ulcer.
  • Unstable diabetes mellitus or any other contraindication for treatment with corticosteroids.
  • AST and/or ALT > 1.5 x UNL associated to alkaline phosphatase > 2.5 x UNL.
  • Any other underlying severe process affecting the ability to take part in the study.
  • Absolute contraindication for steroids.
  • Dementia or significant mental disorder interfering the understanding and giving the informed consent.
  • History of other malignancy except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, radically treated prostatic carcinoma with good prognostic (Gleason = 6). History of other curatively treated malignancy and no evidence of disease within the past 5 years.

Trial locations and contacts

76 sites in 3 countries.

76 sites in 3 countries

Spain48 sites

  • Complejo Hosp. Univ. Juan Canalejo

    A Coruña, 15006

  • F.H.Alcorcón

    Alcorcón, Madrid, 28922

  • H. Virgen de los Lirios

    Alcoy, Alicante, 03804

  • H.G.U. Alicante

    Alicante

  • ICO - H. Germans Trias i Pujol

    Badalona, Barcelona

  • Hospital de Cruces

    Barakaldo, Vizcaya, 48903

  • H. Santa Creu i Sant Pau

    Barcelona, 08025

  • Instituto Universitario Dexeus

    Barcelona, 08028

  • H.U.Vall D´Hebrón

    Barcelona, 08035

  • H. Clinic i Provincial

    Barcelona, 08036

  • H. Althaia

    Barcelona, 08243

  • H. Duran i Reynals-ICO

    Barcelona, 08907

  • H. Provincial de Castellón

    Castellon, Castellón, 12002

  • H. Reina Sofía

    Córdoba, 14004

  • H. de Donostia

    Donostia / San Sebastian, 20014

  • H. Fuenlabrada

    Fuenlabrada, Madrid, 28942

  • ICO Girona -H. Dr. Josep Trueta

    Girona, 17007

  • H. Virgen de las Nieves

    Granada, 18014

  • Complejo Hospitalario de Jaén

    Jaén, 23007

  • Hospital Insular Gran Canaria

    Las Palmas de Gran Canaria, Las Palmas, 35016

  • H. Arnau de Vilanova

    Lleida, 25198

  • Hospital San Millan Y San Pedro

    Logroño

  • H. de la Princesa

    Madrid, 28006

  • H. Gregorio Marañón

    Madrid, 28007

  • H. Ruber Internacional

    Madrid, 28034

  • H.U. Puerta de Hierro

    Madrid, 28035

  • Fundación Jimenez Diaz

    Madrid, 28040

  • Hospial Clinico San Carlos

    Madrid, 28040

  • H. La Paz

    Madrid, 28046

  • H. 12 de Octubre

    Madrid

  • H. Ramon y Cajal

    Madrid

  • H. Carlos Haya

    Málaga, 29010

  • H.C.Universitario Virgen de la Victoria

    Málaga, 29010

  • Hospital de Mataró

    Mataró, Barcelona, 08304

  • H. Son Dureta

    Palma de Mallorca, Mallorca, 07014

  • H. Son Llàtzer

    Palma de Mallorca, 07198

  • Clinica Rotger

    Palma de Mallorca

  • H. Ntra. Sra. de la Candelaria

    Santa Cruz de Tenerife, Tenerife, 38010

  • H. Marqués de Valdecilla

    Santander, Cantabria, 39008

  • H. Virgen del Rocío

    Seville, 41013

  • H. Nuestra Sra. de Valme

    Seville, 41014

  • H. Torrevieja Salud

    Torrevieja, Alicante, 03193

  • H.C.U.Valencia

    Valencia, 46010

  • H. General U. de Valencia

    Valencia, 46014

  • H. Arnau de Vilanova Valencia

    Valencia, 46015

  • H. Dr. Peset

    Valencia, 46017

  • H. Miguel Servet

    Zaragoza, 50009

  • H. Clínico Lozano Blesa

    Zaragoza, 59009

Other trials in Spain

France19 sites

  • Centre Hospitalier Universitaire D'Angers

    Angers

  • Hôpital Auguste Morvan

    Brest, 29200

  • Centre François Baclesse

    Caen, 14000

  • Centre Hospitalier René Dubos

    Cergy-Pontoise

  • Centre Hospitalier Intercommunal

    Créteil, 94010

  • Hôpital A. Mignot

    Le Chesnay

  • Centre Hospitalier Du Mans

    Le Mans

  • Centre Oscar Lambret

    Lille, 59000

  • Hôpital du Cluzeau

    Limoges, 87042

  • Centre Hospitalier Régional

    Longjumeau

  • Centre Hospitalier de Meaux

    Meaux

  • Centre Hospitalier de Mulhouse

    Mulhouse

  • Hôpital Saint Antoine

    Paris, 75571

  • Centre Hospitalier

    Périgueux

  • Centre Hospitalier de La Région D'Annecy

    Pringy

  • CHU Rennes Hôpital Ponchaillou

    Rennes, 35033

  • Centre Hosiptalier Genéral de Roanne

    Roanne

  • Institut de Cancérologie de La Loire

    Saint-Priest-en-Jarez

  • Hôpital Larrey

    Toulouse, 31059

Other trials in France

Italy9 sites

  • CRO di Aviano

    Aviano, 33081

  • AO Materdomini

    Catanzaro, 88100

  • AOU Policlinico G. Martino

    Messina, 98125

  • AO Monaldi

    Naples, 80131

  • Casa di Cura "La Maddalena"

    Palermo, 90146

  • Istituti Fisioterapici Ospitalieri

    Roma, 00128

  • AO S.Camillo Forlanini

    Roma, 00149

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

    Roma, 00161

  • PO di SS.ma Annunziata

    Sassari, 07100

Other trials in Italy

About this study

Official title: Phase III, Multicenter, Open-label, Randomized Trial of Tarceva® vs Chemotherapy in Patients With Advanced NSCLC With Mutations in the TK Domain of the EGFR

A Phase III, multicenter, open-label, randomized trial of Erlotinib (Tarceva®) versus chemotherapy in patients with advanced NSCLC with mutations in the Tyrosine Kinase (TK) domain of the EGFR.

Read the detailed description

This is a multicenter, phase III, randomized, open-label clinical trial.

146 patients with a diagnosis of advanced (stage IIIB and stage IV), non-squamous-cell, non-small-cell pulmonary carcinoma not treated previously for their disease with chemotherapy who present mutation in the tyrosine kinase domain of the epidermal growth factor receptor, EGFR will be recluted.

The primary objective is to compare the progression-free survival in both treatment arms of the study (conventional chemotherapy vs. erlotinib) in patients with non-squamous-cell, non-small-cell lung cancer (NSCLC) in advanced stage (stages IIIB and stage IV) who have not received previous chemotherapy for their disease and who present mutations in the tyrosine kinase domain of the epidermal growth factor receptor (EGFR).

Being tested
Erlotinib, Carboplatin, Gemcitabin, Docetaxel, Cisplatin
Keywords
Lung, cancer, EGFR, Epidermal Growth Factor Receptor, tyrosine kinase, Tarceva®, Erlotinib
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Neoplasms

What participants receive

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

  • ErlotinibDrug

    Also called Tarceva

    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

  • CarboplatinDrug

    Also called Paraplatin

    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.

  • GemcitabinDrug

    Also called Gemzar

    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.

  • DocetaxelDrug

    Also called Taxotere

    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.

  • CisplatinDrug

    Also called Platinol

    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.

Study groups in NCT00446225
Study groupRoleWhat they receive
AExperimentalErlotinib (Tarceva)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
Receives: Drug: Erlotinib
BActive comparator4 cycles of Chemotherapy: Cisplatin / Gemcitabine; Cisplatin /Docetaxel; Carboplatin / Gemcitabine; Carboplatin / Docetaxel. - Cisplatin plus docetaxel: cisplatin 75 mg/m2 i.v. day 1 and docetaxel 75 mg/m2 i.v. day 1. Repeat cycles every 3 weeks. - Cisplatin plus gemcitabine: Cisplatin 75 mg/m2 i.v. on day 1 and gemcitabine 1250 mg/m2 on days 1 and 8. Repeat cycles every 3 weeks. In the case of patients not eligible for treatment with cisplatin, cisplatin can be replaced by carboplatin. The schedules will be the following: Docetaxel 75 mg/m2 day 1 and carboplatin AUC = 6 day 1, every 21 days. Gemcitabine 1000 mg/m2 days 1 and 8 and carboplatin AUC = 5 day 1, every 21 days. 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.
Receives: Drug: Carboplatin; Drug: Gemcitabin; Drug: Docetaxel; Drug: Cisplatin

What is being measured

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

  1. Progression Free-survival

    The time from enrollment in the study to tumor progression or death from any cause (whichever occurs first)

    Measured: From the date of randomization to the date of last follow up, assessed up to 24 months

Secondary outcomes (3)

  1. Objective Response

    The objective response rate is defined as the percentage of patients who attain complete response (CR) or partial response (PR); response will be evaluated following RECIST criteria version 1.0.

    Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progressive disease (PD): at least a 20% increase in the sum of diameters of target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum of diameters recorded on study.

    Measured: From the date of randomization to the date of last follow up, assessed up to 24 months

  2. Overall Survival

    Overall Survival (OS) is defined as the time, in months, from the inclusion date to the death date. A patient is censored at the last contact date if he/she does not die.Overall survival will be assessed from the date of enrollment in the study until the date of death from any cause. Patients lost to follow-up will be censured on the date of the last follow-up visit.

    Measured: From the date of randomization to the date of last follow up, assessed up to 24 months

  3. Molecular Markers Related to EGFR and Study Pathology

    The study of mutations in serum (serum DNA). This exploratory analysis was performed to determine whether EGFR mutations can reliably be detected in serum thereby reducing the requirement for invasive techniques as well as to enable detection of mutations in patients where no tumor biopsy samples are available.

    Measured: At baseline

Timeline

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

  1. First posted12 Mar 2007 (estimated)
  2. Study start15 Feb 2007
  3. Primary completion11 Apr 2012
  4. Study completionDec 2012

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
174 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00446225
Sponsor's protocol ID
EURTAC-SLCG // GECP06/01
Other IDs
2006-003568-73
Acronym
EURTAC
Status last verified
Feb 2025
First submitted
8 Mar 2007
Last updated
5 Mar 2025
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Rosell R, Carcereny E, Gervais R, Vergnenegre A, Massuti B, Felip E, Palmero R, Garcia-Gomez R, Pallares C, Sanchez JM, Porta R, Cobo M, Garrido P, Longo F, Moran T, Insa A, De Marinis F, Corre R, Bover I, Illiano A, Dansin E, de Castro J, Milella M, Reguart N, Altavilla G, Jimenez U, Provencio M, Moreno MA, Terrasa J, Munoz-Langa J, Valdivia J, Isla D, Domine M, Molinier O, Mazieres J, Baize N, Garcia-Campelo R, Robinet G, Rodriguez-Abreu D, Lopez-Vivanco G, Gebbia V, Ferrera-Delgado L, Bombaron P, Bernabe R, Bearz A, Artal A, Cortesi E, Rolfo C, Sanchez-Ronco M, Drozdowskyj A, Queralt C, de Aguirre I, Ramirez JL, Sanchez JJ, Molina MA, Taron M, Paz-Ares L; Spanish Lung Cancer Group in collaboration with Groupe Francais de Pneumo-Cancerologie and Associazione Italiana Oncologia Toracica. Erlotinib versus standard chemotherapy as first-line treatment for European patients with advanced EGFR mutation-positive non-small-cell lung cancer (EURTAC): a multicentre, open-label, randomised phase 3 trial. Lancet Oncol. 2012 Mar;13(3):239-46. doi: 10.1016/S1470-2045(11)70393-X. Epub 2012 Jan 26.

    PubMed 22285168

  • Karachaliou N, Mayo-de las Casas C, Queralt C, de Aguirre I, Melloni B, Cardenal F, Garcia-Gomez R, Massuti B, Sanchez JM, Porta R, Ponce-Aix S, Moran T, Carcereny E, Felip E, Bover I, Insa A, Reguart N, Isla D, Vergnenegre A, de Marinis F, Gervais R, Corre R, Paz-Ares L, Morales-Espinosa D, Viteri S, Drozdowskyj A, Jordana-Ariza N, Ramirez-Serrano JL, Molina-Vila MA, Rosell R; Spanish Lung Cancer Group. Association of EGFR L858R Mutation in Circulating Free DNA With Survival in the EURTAC Trial. JAMA Oncol. 2015 May;1(2):149-57. doi: 10.1001/jamaoncol.2014.257.

    PubMed 26181014

  • Karachaliou N, Gimenez-Capitan A, Drozdowskyj A, Viteri S, Moran T, Carcereny E, Massuti B, Vergnenegre A, de Marinis F, Molina MA, Teixido C, Rosell R. ROR1 as a novel therapeutic target for EGFR-mutant non-small-cell lung cancer patients with the EGFR T790M mutation. Transl Lung Cancer Res. 2014 Jun;3(3):122-30. doi: 10.3978/j.issn.2218-6751.2014.03.02.

    PubMed 25806291

  • Costa C, Molina MA, Drozdowskyj A, Gimenez-Capitan A, Bertran-Alamillo J, Karachaliou N, Gervais R, Massuti B, Wei J, Moran T, Majem M, Felip E, Carcereny E, Garcia-Campelo R, Viteri S, Taron M, Ono M, Giannikopoulos P, Bivona T, Rosell R. The impact of EGFR T790M mutations and BIM mRNA expression on outcome in patients with EGFR-mutant NSCLC treated with erlotinib or chemotherapy in the randomized phase III EURTAC trial. Clin Cancer Res. 2014 Apr 1;20(7):2001-10. doi: 10.1158/1078-0432.CCR-13-2233. Epub 2014 Feb 3.

    PubMed 24493829

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Erlotinib, Carboplatin and Gemcitabin in people with Non-Small Cell Lung Cancer, run by Spanish Lung Cancer Group at 76 sites in 3 countries.

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 22 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: finished, as of the sponsor's last update on 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 76 sites in Spain, France, 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?

Yes. Results are posted in the registry (first posted 5 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free-survival (time frame: From the date of randomization to the date of last follow up, assessed up to 24 months). 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 NCT00446225, which also lists 4 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 5 Mar 2025.

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