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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Spanish Lung Cancer Group
ClinicalTrials.gov Identifier:
NCT00446225
First received: March 8, 2007
Last updated: March 8, 2013
Last verified: October 2008
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Spanish Lung Cancer Group:

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

Secondary Outcome Measures:
  • 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. ]

Enrollment: 174
Study Start Date: February 2007
Study Completion Date: December 2012
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00446225

  Show 76 Study Locations
Sponsors and Collaborators
Spanish Lung Cancer Group
Investigators
Study Chair: Rafael Rosell i Costa, MD Spanish Lung Cancer Group
Study Chair: Luis Paz-Ares, MD Spanish Lung Cancer Group
  More Information

Additional Information:
No publications provided by Spanish Lung Cancer Group

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Spanish Lung Cancer Group
ClinicalTrials.gov Identifier: NCT00446225     History of Changes
Other Study ID Numbers: EURTAC-SLCG // GECP06/01, EudraCT:2006-003568-73
Study First Received: March 8, 2007
Last Updated: March 8, 2013
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Spanish Lung Cancer Group:
Lung
cancer
EGFR
Epidermal Growth Factor Receptor
tyrosine kinase
Tarceva®
Erlotinib

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Gemcitabine
Docetaxel
Cisplatin
Carboplatin
Erlotinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents

ClinicalTrials.gov processed this record on October 01, 2014