A Prospective, Randomized, Multicenter, Open Label Phase III Study of Active Specific Immunotherapy With Racotumomab Plus Best Support Treatment Versus Best Support Treatment in Patients With Advanced Non-small Cell Lung Camcer.
1. Voluntarily signed informed consent.
2. Cytologic or histologically diagnosed NSCLC in stages IIIA (non-resectable) or IIIB
or IV (TNM).
3. In continuous complete or partial remission or stable disease according to Response
Evaluation Criteria in Solid Tumours (RECIST) after standard first-line treatment.
4. Imaging studies documenting the response to first-line therapy must be available for
evaluation by the investigator.
5. Time lapse of 21 to 56 days between the end of onco-specific treatment and start of
vaccination. Patients must have recovered from any acute toxicity produced by
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 days
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 the
place of evaluation or 2.5 fold the maximum normal value in case of liver metastases
8.7. Glutamic-oxaloacetic transaminase/aspartate aminotransferase (GOT/AST), and
glutamic-pyruvic transaminase/alanine aminotransferase (GPT/ALT), less than or equal
to 2.5 fold the maximum normal value at the place of evaluation (in case of liver
metastasis, 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 accepted
limits are eligible
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 on
4. Disease progression prior to randomization
5. Recurrent NSCLC, who relapse less than one year after completing curative intent
6. Patients receiving other investigational medication (including investigational
immunotherapy for NSCLC) or having received such medication within 30 days before
entering 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
system or the peripheral nervous system
11. Non-controlled intercurrent diseases, including active infections, symptomatic
congestive heart failure, unstable chest angina or heart arrhythmia, as well as
mentally incapable patients
12. Other malignant diseases except non- melanoma skin cancer, in situ carcinoma of the
cervix, incidental prostate cancer (T1a, Gleason less than or equal to 6, prostate
specific antigen (PSA) less than 0.5 ng/ml) or any other tumour having received
adequate treatment and evidencing a disease-free period greater than or equal to 5
13. Receiving chronic therapy for more than 10 days at doses of prednisone greater than
10 mg/day (or equivalent) at the moment of the inclusion. Inhaled and topical
corticosteroids are allowed.
14. Active hepatitis C or positive tests for human immunodeficiency virus (HIV)