Randomized Customized Adjuvant Chemotherapy (GECP-SCAT)

Phase III, Open, Multicenter and Randomized Study of Customized Adjuvant Chemotherapy Based on BRCA1 mRNA Levels in Completely Resected Stages II-IIIA Non-Small-Cell Lung Cancer Patients

Randomized Study of Customized Adjuvant Chemotherapy based on BRCA1 mRNA Levels in Completely Resected stages II-IIIA Non-Small-Cell Lung Cancer Patients.

Randomized, phase III, predictive pharmacogenomic, open, prospective, international, multicenter study in patients with non-small-cell lung carcinoma (NSCLC) after complete resection and with N1 or N2 involvement

Inclusion Criteria:

• Patients with histological confirmation of non-small-cell lung carcinoma.
• Complete surgical resection of the disease.
• Tumoral tissue available for molecular analysis.
• N1 (stage II) or N2 (stage IIIA) lymph node involvement in the study of the operative piece.
• Men or women age 18 years or older.
• Patients with a performance status of 2 or less according to the ECOG classification.
• Patients with the following laboratory results: ANC < 1500/L, Hb < 10 g/dL, platelets <100,000/L, bilirubin < 1.0 mg/dL, AST and ALT < 1.5 upper limit of normality, creatinine clearance < 60 mL/min.
• Complete recovery from surgery within 6 weeks.
• Patients who have given written informed consent before initiating any specific study screening procedure.

Exclusion Criteria:

• Patients who have received previously chemotherapy or radiotherapy for the study disease.
• Impossibility of complying with chemotherapy treatment due to cultural or geographic circumstances.
• Patients with active infection, heart disease, or any other serious disease, in the judgment of the investigator.
• Women who are pregnant or in the period of lactation.
• Patients with a previous diagnosis of malignant disease in the last five years except for carcinoma in situ of the uterine cervix or skin cancer other than melanoma.
• Patients under treatment with investigational agents.