Immunotherapy With Racotumomab in Advanced Lung Cancer
NSCLC, Lung Cancer, Non-small Cell
About this trial
This is an interventional treatment trial for NSCLC focused on measuring NSCLC, Lung cancer, small-cell, advanced lung cancer, therapeutic vaccine, anti-idiotypic vaccine, 1E10
Eligibility Criteria
Inclusion Criteria:
- Voluntarily signed informed consent.
- Cytologic or histologically diagnosed NSCLC in stages IIIA (non-resectable) or IIIB or IV (TNM).
- In continuous complete or partial remission or stable disease according to Response Evaluation Criteria in Solid Tumours (RECIST) after standard first-line treatment.
- Imaging studies documenting the response to first-line therapy must be available for evaluation by the investigator.
- 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 previous therapy.
- Age greater than or equal to 18 years, either sex.
- Eastern Cooperative Oncology Group performance status less than 2.
Adequate organ function, defined as follows:
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 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)
- Known hepatitis B virus carriers who have liver function tests within the accepted limits are eligible
Exclusion Criteria:
- Pregnant or breastfeeding patients
- Known hypersensitivity to any component of the formulation
- Fertile patients of either sex who do not use adequate contraceptive methods while on treatment
- Disease progression prior to randomization
- Recurrent NSCLC, who relapse less than one year after completing curative intent therapy
- Patients receiving other investigational medication (including investigational immunotherapy for NSCLC) or having received such medication within 30 days before entering the protocol
- Autoimmune diseases or chronic decompensated diseases
- Acute allergic disorders or a history of severe allergic reactions
- Known brain metastases
- History of demyelinating disease or inflammatory disease of the central nervous system or the peripheral nervous system
- Non-controlled intercurrent diseases, including active infections, symptomatic congestive heart failure, unstable chest angina or heart arrhythmia, as well as mentally incapable patients
- 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
- 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.
- Active hepatitis C or positive tests for human immunodeficiency virus (HIV)
Sites / Locations
- Instituto Médico CER
- Policlínica Privada Instituto de Medicina Nuclear
- Hospital Italiano
- Hospital Privado de Córdoba
- Instituto Oncológico de Córdoba
- Fundación COIR
- Centro Oncológico de Rosario
- ISIS Clinica Especializada
- NOB - Nucleo de Oncologia da Bahia
- CRIO - Centro Regional Integrado de Oncologia
- Hospital Universitário de Brasília
- Pro Onco - Centro de Tratamento Oncológico
- Hospital da Cidade de Passo Fundo
- UPCO - Unidade de Pesquisas Clínicas em Oncologia
- HCPA - Hospital de Clínicas de Porto Alegre
- Hospital de Base de São José do Rio Preto
- Hospital Universitário de Brasília
- Centro de Oncologia do Parana
- CRIO - Centro Regional Integrado de Oncologia
- Hospital Amaral de Carvalho
- Pro Onco - Centro de Tratamento Oncológico
- Centro Oncologico de Mogi das Cruzes
- Liga Norte Riograndense Contra o Cancer
- Hospital da Cidade de Passo Fundo
- UPCO - Unidade de Pesquisas Clínicas em Oncologia
- HCPA - Hospital de Clínicas de Porto Alegre
- Hospital Moinhos de Vento
- Oncologistas Associados
- NOB - Nucleo de Oncologia da Bahia
- Faculdade de Medicina do ABC
- GRAM - Grupo de Assistencia Medica e Prestacao de Servicos
- Hospital de Base de São José do Rio Preto
- Hospital "Hermanos Ameijeiras"
- Hospital "Celestino Hernández Robau"
- Hospital Jose Ramon Lopez Tabranes
- Dr Moewardi Hospital
- Persahabatan Hospital
- RS Kanker 'Dharmais'
- Dr Soetomo Hospital
- Dr Sardjito Hospital
- Perpetual Succour Hospital
- Veterans Memorial Medical Center
- Johns Hopkins Singapore International Medical Centre
- Chiang Mai Hospital
- Khon Kaen Hospital, Division of Pulmonary and Critical Care Medicine
- Songklanagarind Hospital - HOCC-PSU
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Racotumomab plus Best Support Treatment
Best Support Treatment
Patients will receive Racotumomab and Best Support Treatment, which includes any further onco-specific therapy for progressive disease.
Patients will receive best support treatment for advanced NSCLC including onco-specific therapies when disease progresses.