A Prospective, Randomised, Open Label Phase II Study of Active Specific Immunotherapy With Racotumomab Versus Support Treatment in Patients With Advanced Non-small Cell Lung Cancer
Inclusion Criteria:
1. The patient (aged over 21 years, either sex) can comply with the protocol and
scheduled appointments and sign voluntarily the informed consent form
2. Diagnosis of Non-small cell lung cancer (NSCLC) stages IIIA (surgically
unresectable), IIIB or IV, according to the TNM classification
(Tumor-Nodes-Metastases) version 6a, confirmed by cytology or histology, if possible
available for determination of ganglioside expression
3. Patients may enter the study if they have accomplished an objective response
(complete response or partial response) or disease stabilisation (by Response
Evaluation Criteria In Solid Tumours [RECIST]) after completion of standard
onco-specific treatment. In all cases, response should be documented.
For stage IIIA and IIIB without pleural effusion ("dry IIIB") standard treatment is
considered as follows: 2 - 4 cycles of platinum-based chemotherapy and/or
radiotherapy with curative intent in accordance with National Comprehensive Cancer
Network (NCCN) guidelines For stage IIIB with pleural effusion ("wet IIIB") and stage
IV standard treatment is considered as follows: 4 - 6 cycles of chemotherapy based on
platinum. In case of pleural or pericardial effusion requiring local treatment, it
will be provided prior to study entry.
4. Patients with an interval greater than 30 and not more than 90 days between the
completion of oncospecific treatment and study entry. Completion of treatment is
defined as the last day of administration of chemotherapy or the last day of
radiotherapy. Patients should have recovered from any related episode of acute
toxicity of degree greater than 1 (except alopecia). Patients who have received a
monoclonal antibody (eg bevacizumab) should also have discontinued its use for at
least 30 days before inclusion.
5. The subject is male or female, aged greater than or equal to 21 years
6. Performance status (Eastern Cooperative Oncology Group [ECOG]) less than or equal to
1
7. Acceptable organ functionality as defined by the following parameters:
- Electrocardiogram (ECG) without significant abnormalities, performed within 14
days prior to admission
- Haemoglobin greater than or equal to 90 g/L
- Total leukocyte count greater than or equal to 3.0 x 10^9/L
- Absolute neutrophil count greater than or equal to 1.5 x 10^9/L
- Total bilirubin less than or equal to 1.5 times upper limit of normal or twice
the limit normal than in case liver metastases are present
- Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic
transaminase (SGPT) less than or equal to 2.5 times upper limit of normal (less
than or equal to five times the normal maximum in case liver metastases are
present)
- Creatinine less than or equal to 2 mg/dL
8. Life expectancy of at least four months
Exclusion Criteria:
1. Patient is pregnant or breastfeeding
2. Has received chemotherapy, radiotherapy, immunotherapy or surgery within 30 days
prior to inclusion
3. Hypersensitivity to any component of the formulation
4. Patients of childbearing potential of either sex who are not using an adequate method
of contraception during treatment to avoid pregnancy (own or of partner). For
females: intrauterine devices, hormonal contraceptives, barrier methods or
sterilisation. For males: vasectomy or condoms with spermicide.
5. Patients receiving or having received other investigational drugs 30 days prior to
study entry
6. History of autoimmune diseases
7. Decompensated chronic diseases
8. Acute allergic disorders or history of severe allergic reactions
9. Known brain metastases uncontrolled with surgery and/or radiation therapy or under
current corticosteroid therapy
10. History of inflammatory or demyelinating disease of the central or peripheral nervous
system
11. Uncontrolled intercurrent illnesses, including active infection, symptomatic
congestive heart failure, unstable angina or cardiac arrhythmia and psychiatric
diseases implying patient incompetence
12. Other malignancies, with the exception of basal cell carcinoma, in situ cervical
carcinoma, incidental prostate cancer (T1a, Gleason less than or equal to 6, prostate
specific antigen [PSA] less than 0.5 ng/ml), tumour or any other tumour adequately
treated and with a disease-free period greater than or equal to 5 years
13. Chronic treatment with systemic corticosteroids at doses greater than 0.5 mg/kg/day
or a maximum of 40 mg/day of prednisone or equivalent
14. The subject has a history of drug abuse (illicit drugs) or alcohol abuse (defined as
regular or periodic ingestion of more than four drinks a day) in the last 2 years
15. Positive serology for hepatitis B, C or known human immunodeficiency virus (HIV)
infection
16. Uncontrolled hypercalcaemia greater than or equal to 2.9 mmol/L (or grade greater
than 1 according to the Common Terminology Criteria for Adverse Events [CTCAE]
version 3.0)