Study of 3D Radiotherapy With or Without Erlotinib (Tarceva®) in Patients With Localized Non-Small Cell Lung Cancer

Inclusion Criteria:

• Written informed consent prior to any specific procedure of the protocol.
• Histologically confirmed diagnosis of non small cell lung cancer.
• Unresectable (IA-IIIB) non-small cell lung cancer.
• Patients non susceptible for chemotherapy treatment
• Measurable disease according to RECIST criteria
• Age > 18 years.
• ECOG performance status < 2.
• Adequate bone marrow, hepatic, renal and respiratory function.
• Patients capable of following an adequate therapeutic compliance and accessible for a correct follow-up.
• Women at a fertile age must have a negative serum or urine pregnancy test within the 7 days prior to the beginning of the treatment.
• 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.

Exclusion Criteria:

• Prior chemotherapy or radiotherapy.
• History of other curatively treated malignancy and no evidence of disease within the past 5 years except squamous cell skin cancer, or resected cervix carcinoma.
• Pregnant or lactating women.

• Any other severe disease or clinical conditions, as, but not only:

  1. Unstable cardiopathy despite treatment, myocardial infarction within the 6 months before entering the study
  2. Uncontrolled active infection
  3. Uncontrolled peptic ulcer, unstable diabetes mellitus or any other contraindication for treatment with corticosteroids.
  4. Autoimmune diseases.
• Concomitant treatment with any other antineoplastic therapy.
• Prior experimental pharmacological agent within the 3 weeks prior to the inclusion of the study.
• Prior treatment with EGFR targeted therapies.
• Erlotinib known hypersensibility.
• Any radiotherapy treatment contraindication.
• History of significant neurological or psychiatric disorders, including epileptic seizures.
• Any significant ophthalmologic impairment of the eye surface (Use of contact lenses is not recommended)
• Inability to take oral medication and surgical procedures affecting the absorption or implying intravenous or parenteral feeding.
• Any other underlying severe process affecting the ability to take part in the study.