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

Phase II Randomized Trial of 3D Radiotherapy Versus the Combination of 3D Radiotherapy and Erlotinib (Tarceva®) in Patients With Localized-Unresectable Non-Small Cell Lung Cancer Non Susceptible for Chemotherapy Treatment.

A phase II, multicenter, randomized trial of 3D Radiotherapy versus 3D Radiotherapy and erlotinib (Tarceva®) in patients with localized-unresectable (IA-IIIB) non-small cell lung cancer non susceptible for chemotherapy treatment, to compare safety and toxicity profile, and the progression-free survival in both arms of treatment (3D Radiotherapy versus 3D Radiotherapy + erlotinib) in patients who have not received previous chemotherapy.

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.