Racotumomab-alum is an anti-idiotypic vaccine that induces immunological response against N-glycolilated gangliosides in NSCLC patients. Nimotuzumab is a humanized anti-EGFR monoclonal antibody that has shown activity in NSCLC patients. The aim of this study is to evaluate safety and efficacy of racotumomab-alum or nimotuzumab versus docetaxel as second line or switch maintenance therapy for advanced NSCLC.
This phase III, multicenter, open label, randomized trial is designed to enroll 743 stage IIIB-IV NSCLC patients, after first line therapy, with PS 0-2, with written informed consent. The primary endpoint is Overall Survival (OS). Patients are been randomized (2:2:1) to 3 arms: racotumomab-alum, nimotuzumab or docetaxel, and stratified according to response to first line (progressor or non-progressor patients). Racotumomab-alum treatment consists in 5 bi-weekly intradermal doses and re-immunizations every 4 weeks. Nimotuzumab arm receives 6 weekly infusions followed by bi-weekly doses. Docetaxel is used at 75 mg/m2 for 6 cycles, if there is no evidence of progressive disease after 3 cycles. As second-line therapy, both experimental drugs will be classified as non-inferior (NI) to docetaxel, if 1- year OS rate is 23.1 % and HR C/T=0.76, [d0 (0,28), d0= - ln HR(C/T)] using a 10% NI margin. Here we report the interim analysis in 255 progressor patients.
106 patients in racotumomab, 97 in nimotuzumab and 54 in docetaxel arm with at least 1 year follow up were analyzed (ITT). The median OS and 1-year survival rate were 4.67 months (CI: 4.0-5.3) and 14.5 % with nimotuzumab, 4.83 months (CI: 3.7-5.9) and 23.5 % with racotumomab-alum and 5.85 months (CI: 3.9-7.7) and 20.2 % with docetaxel, respectively. Most frequent treatment-related adverse events were induration (10.7%), local erythema in injection site (8.8%) and arthralgia (8.2%) with racotumomab-alum; myalgia (12.1%), fever (7.9%) and nausea (7.0%) with nimotuzumab, and nausea (16.5%), asthenia (13.2%) and vomiting (12.1%) after docetaxel.
These data do not confirm the non-inferiority of racotumomab-alum or nimotuzumab versus docetaxel as second-line therapy. Both experimental treatments were safely administered at primary level of health assistance.
Clinical trial identification
Legal entity responsible for the study
Center of Molecular Immunology.
Center for Molecular Immunology.
M. Hernandez, C. Viada, T. Crombet: Employed: Center of Molecular Immunology. All other authors have declared no conflicts of interest.