Advanced non-small cell lung cancer Cancer Malignant neoplasm of the lung
Conditions
Interventions
Patients will be randomised to either:
1. Best support treatment alone, or
2. Best support treatment plus racotumomab
All patients will receive best su
Sponsors
Recombio SL (Spain)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who have voluntarily signed the informed consent 2. Patients with newly diagnosed advanced NSCLC or patients with recurrent NSCLC, at least 1 year after completing curative intent therapy, who present with disease in stages IIIA (non-resectable) or IIIB or IV by TNM classification, confirmed by cytology or histology 3. Patients who have achieved a complete remission (CR) or partial remission (PR) or stable disease (SD) according to Response Evaluation Criteria in Solid Tumours (RECIST) after standard first-line treatment and remain free of progression at the study inclusion time. Standard first-line therapy is defined as: 3.1. For patients with stage IIIA and IIIB, without pleural effusion ('dry IIIB'): 2 to 4 cycles of platinum-based chemotherapy and/or radiotherapy with curative intent as per NCCN guidelines 3.2. For patients with stage IIIB with pleural effusion ('wet IIIB') and stage IV patients: 4 to 6 cycles of platinum-based chemotherapy. In case of pleural or pericardial effusion local therapy, if necessary, will be performed prior to enrolment in the study (catheter setting or draining) 4. Imaging studies documenting the response to first-line therapy must be available for assessment by the investigator 5. Patients with a time lapse of 21 to 56 days between the end of onco-specific treatment and start of vaccination. End of previous onco-specific therapy is defined as 21 days after the last dose of systemic therapy or last administration of radiotherapy. Patients must have recovered from any acute toxicity produced by previous therapy 6. Patients greater than or equal to 18 years of age, either sex 7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) less than or equal to 1 8. Patients with adequate organ function, as defined by the following parameters: 8.1. Electrocardiogram (ECG) without significant anomalies, performed in the 7 days preceding 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 the place of evaluation or 2.5 fold the maximum normal value in case of liver metastasis 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
Exclusion criteria
Exclusion criteria: 1. Pregnant or breastfeeding patients 2. Patients with known hypersensitivity to any component of the formulation 3. Fertile patients of either sex who do not use adequate contraceptive methods while on treatment 4. Patients whose disease progressed after clinical benefit with first-line onco-specific treatment 5. Patients with recurrent NSCLC, who relapse less than one year after completing curative intent therapy 6. Patients receiving other investigational medication (including investigational immunotherapy for NSCLC) or having received such medication within 30 days before entering the protocol 7. Patients with autoimmune diseases or chronic decompensated diseases 8. Patients with acute allergic disorders or a history of severe allergic reactions 9. Patients with known brain metastases 10. Patients with a history of demyelinating disease or inflammatory disease of the central nervous system or the peripheral nervous system 11. Patients suffering from non-controlled intercurrent diseases, including active infections, symptomatic congestive heart failure, unstable chest angina or heart arrhythmia, as well as mentally incapable patients 12. Patients with 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 years 13. Patients 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. Patients with known active hepatitis C or positive tests for human immunodeficiency virus (HIV)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Overall survival (OS) in the study population as a whole 2. Overall survival (OS) in the subgroup of patients with stages IIIA and dry IIIB Survival time will be monitored from the date of random assignment to the date of death or last censored observation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Progression free survival (PFS) measured using RECIST; tumour evaluations will be performed from baseline visit and every 2 months 2. Safety (adverse events as per common toxicity criteria [CTC]) 3. Correlation of immunological parameters with treatment efficacy | — |
Countries
Argentina, Brazil, Cuba, India, Korea, South, Singapore, Taiwan, Uruguay
Outcome results
None listed