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

March 8, 2007
March 12, 2007
March 11, 2013
February 2007
December 2009   (Final data collection date for primary outcome measure)
Progression Free-survival [ Time Frame: Every 6 weeks ]
Progression Free-survival
Complete list of historical versions of study NCT00446225 on Archive Site
  • Objective Response [ Time Frame: Every 6 weeks ]
  • One year survival
  • Overall survival
  • Safety incidence
  • Life quality [ Time Frame: At baseline, every 3 weeks during treatment period, end of treatment visit and every 3 months during follow up period. ]
  • Molecular markers related to EGFR and study pathology [ Time Frame: At baseline, after 6 months of inclusion and at progression. ]
  • Objective Response
  • One year survival
  • Overall survival
  • Progression allocation
  • Safety incidence
  • Life cuality
  • Molecular markers related to EGFR and study pathology
Not Provided
Not Provided
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
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.
Not Provided
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Non-Small Cell Lung Cancer
  • Drug: Erlotinib (Tarceva)
    150 mg/day
  • 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)
  • Experimental: A
    Erlotinib (Tarceva)150 mg /day
    Intervention: Drug: Erlotinib (Tarceva)
  • Active Comparator: B

    4 cycles of Chemotherapy:

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

    Intervention: Drug: Carboplatin // Gemcitabine // Docetaxel //Cisplatin

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2012
December 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
France,   Italy,   Spain
Not Provided
Not Provided
Spanish Lung Cancer Group
Spanish Lung Cancer Group
Not Provided
Study Chair: Rafael Rosell i Costa, MD Spanish Lung Cancer Group
Study Chair: Luis Paz-Ares, MD Spanish Lung Cancer Group
Spanish Lung Cancer Group
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP