Immunotherapy With Racotumomab in Advanced Lung Cancer

Inclusion Criteria:

1. Voluntarily signed informed consent.

2. Cytologic or histologically diagnosed NSCLC in stages IIIA (non-resectable) or IIIB orIV (TNM).

3. In continuous complete or partial remission or stable disease according to ResponseEvaluation Criteria in Solid Tumours (RECIST) after standard first-line treatment.

4. Imaging studies documenting the response to first-line therapy must be available forevaluation by the investigator.

5. Time lapse of 21 to 56 days between the end of onco-specific treatment and start ofvaccination. Patients must have recovered from any acute toxicity produced by previoustherapy.

6. Age greater than or equal to 18 years, either sex.

7. Eastern Cooperative Oncology Group performance status less than 2.

8. Adequate organ function, defined as follows:

8.1. Electrocardiogram (ECG) without significant anomalies, performed in the 7 dayspreceding entry

8.2. Haemoglobin greater than or equal to 90 g/L

8.3. Total white blood cell count (WBC) greater than or equal to 3.0 x 10^9/L

8.4. Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10^9/L

8.5. Platelet count greater than 100 x 10^9/L

8.6. Total bilirubin less than or equal to 1.5 fold the maximum normal value at theplace of evaluation or 2.5 fold the maximum normal value in case of liver metastases

8.7. Glutamic-oxaloacetic transaminase/aspartate aminotransferase (GOT/AST), andglutamic-pyruvic transaminase/alanine aminotransferase (GPT/ALT), less than or equalto 2.5 fold the maximum normal value at the place of evaluation (in case of livermetastasis, less than 5 fold the maximum normal value)

8.8. Creatinine less than or equal to 2 mg/dL (less than or equal to 176 µmol/L)

9. Known hepatitis B virus carriers who have liver function tests within the acceptedlimits are eligible

Exclusion Criteria:

1. Pregnant or breastfeeding patients

2. Known hypersensitivity to any component of the formulation

3. Fertile patients of either sex who do not use adequate contraceptive methods while ontreatment

4. Disease progression prior to randomization

5. Recurrent NSCLC, who relapse less than one year after completing curative intenttherapy

6. Patients receiving other investigational medication (including investigationalimmunotherapy for NSCLC) or having received such medication within 30 days beforeentering the protocol

7. Autoimmune diseases or chronic decompensated diseases

8. Acute allergic disorders or a history of severe allergic reactions

9. Known brain metastases

10. History of demyelinating disease or inflammatory disease of the central nervous systemor the peripheral nervous system

11. Non-controlled intercurrent diseases, including active infections, symptomaticcongestive heart failure, unstable chest angina or heart arrhythmia, as well asmentally incapable patients

12. Other malignant diseases except non- melanoma skin cancer, in situ carcinoma of thecervix, incidental prostate cancer (T1a, Gleason less than or equal to 6, prostatespecific antigen (PSA) less than 0.5 ng/ml) or any other tumour having receivedadequate treatment and evidencing a disease-free period greater than or equal to 5years

13. Receiving chronic therapy for more than 10 days at doses of prednisone greater than 10mg/day (or equivalent) at the moment of the inclusion. Inhaled and topicalcorticosteroids are allowed.

14. Active hepatitis C or positive tests for human immunodeficiency virus (HIV)