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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00446225
Recruitment Status : Completed
First Posted : March 12, 2007
Last Update Posted : March 11, 2013
Information provided by (Responsible Party):
Spanish Lung Cancer Group

Brief 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.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Drug: Erlotinib (Tarceva) Drug: Carboplatin // Gemcitabine // Docetaxel //Cisplatin Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 174 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : February 2007
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: A
Erlotinib (Tarceva)150 mg /day
Drug: Erlotinib (Tarceva)
150 mg/day

Active Comparator: B

4 cycles of Chemotherapy:

Cisplatin / Gemcitabine; Cisplatin /Docetaxel; Carboplatin / Gemcitabine; Carboplatin / Docetaxel.

Drug: Carboplatin // Gemcitabine // Docetaxel //Cisplatin
Cisplatin (75 mg/m2) / Docetaxel (75 mg/m2); Cisplatin (75 mg/m2) / Gemcitabine (1250 mg/m2; day 1 and 8); Docetaxel (75 mg/m2) /carboplatin (AUC=6); Gemcitabine (1000 mg/m2; day 1 and 8) / Carboplatin (AUC=5)

Primary Outcome Measures :
  1. Progression Free-survival [ Time Frame: Every 6 weeks ]

Secondary Outcome Measures :
  1. Objective Response [ Time Frame: Every 6 weeks ]
  2. One year survival
  3. Overall survival
  4. Safety incidence
  5. Life quality [ Time Frame: At baseline, every 3 weeks during treatment period, end of treatment visit and every 3 months during follow up period. ]
  6. Molecular markers related to EGFR and study pathology [ Time Frame: At baseline, after 6 months of inclusion and at progression. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  • 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
  • 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

Exclusion criteria:

  • 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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00446225

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Sponsors and Collaborators
Spanish Lung Cancer Group
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Study Chair: Rafael Rosell i Costa, MD Spanish Lung Cancer Group
Study Chair: Luis Paz-Ares, MD Spanish Lung Cancer Group
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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, Muñoz-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 Français de Pneumo-Cancérologie 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.

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Responsible Party: Spanish Lung Cancer Group Identifier: NCT00446225    
Other Study ID Numbers: EURTAC-SLCG // GECP06/01
First Posted: March 12, 2007    Key Record Dates
Last Update Posted: March 11, 2013
Last Verified: October 2008
Keywords provided by Spanish Lung Cancer Group:
Epidermal Growth Factor Receptor
tyrosine kinase
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Erlotinib Hydrochloride
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Protein Kinase Inhibitors