Multicenter Phase III, Randomized Study to Evaluate Treatment Customized According to RAP80 and BRCA1 Assessment in Patients With Advanced Non-small-cell Lung Cancer
1. Patients age 18 years or more.
2. Histologically confirmed diagnosis of non-small-cell lung carcinoma.
3. Only patients with advanced disease defined as stage IV or IIIB with or without
pleural effusion will be included. In the event of IIIB disease without pleural
effusion those patients, who for some reason (respiratory disease, large radiation
volume...) may not be candidates to have chemotherapy and radiotherapy treatment and
may only be treated with chemotherapy, will be considered.
4. Tumor specimen available (according to the criterion of the specimen-processing
laboratory) for the analysis of RAP80 and BRCA1 expression in mRNA.
5. A measurable lesion, as defined by RECIST criteria.
6. Karnofsky score 80% or more (ECOG < 2).
7. No previous treatment with chemotherapy or other agents for disseminated disease.
Chemotherapy is allowed if the patient's initial diagnosis is limited disease and the
patient has received adjuvant or neoadjuvant treatment, as long as a minimum of 6
months has passed since the end of the adjuvant and/or neo-adjuvant chemotherapy.
8. Patients with cerebral disease may be included without any time limitations after
holocranial irradiation or complementary antiedema treatment, as long as there is
correct control of the clinical symptoms arising from the brain disease or is
9. Patients with the following hematologic values:
ANC ≥ 1.5 x 109/L Hb ≥ 10 g/dl Platelets ≥ 100 x 109/L
10. Patients with the following biochemical values:
Bilirubin ≤ 1.5 mg/dL AST and ALT < 1.5 upper limit of normality Creatinine clearance
≥ 60 ml/min.
11. Patients of childbearing age of either sex must use effective contraceptive methods
(barrier methods or other birth control methods) before entering the study and while
participating in the study.
12. Patients should sign an informed consent form before inclusion in the study that
specifies that the clinical trial treatment entails consent for the analysis of
biological specimens of tumor and blood.
13. Patients must be available for clinical follow-up.
1. Previous chemotherapy treatment, except the supposition reflected in inclusion
2. Patients diagnosed of another neoplasm, with the exception of cervical carcinoma in
situ, treated squamous cell carcinomas or superficial bladder tumors (Ta and TIS), or
other malignant tumors that have received curative treatment within the last 5 years
before inclusion in the study.
3. Patients with serious active bacterial or fungal infective processes from a clinical
vantage point (= grade 2 of NCI-CTC, Version 3).
4. Patients who have received an investigational medicinal product in the 21 days before
inclusion in the study.
5. Patients with HIV infection, HCV infection, coronary artery disease or uncontrolled
arrhythmia, uncontrolled cerebrovascular disease, or other clinical conditions that,
in the judgment of the investigator, contraindicate the patient's participation in
6. Patients who are pregnant or breastfeeding. Women of childbearing age must have a
negative pregnancy test performed within 7 days before the onset of treatment.
7. Substance abuse and clinical, psychological or social conditions that can undermine
the validity of the informed consent or protocol compliance.
8. Patients who present any contraindication or suspected allergy to the products under
investigation in the study
9. Impossibility to comply with chemotherapy treatment due to cultural or geographic
10. Significant weight loss (= 10% of body weight) in the 6 weeks before inclusion in the
11. Any condition that is unstable or could endanger the patient's safety and/or the
patient's compliance with the study.
12. Contraindication for steroid use.