None listed
Conditions
Interventions
MB02 (Biosimilar) 25 mg/mL - caja/ 1 vial de 100mg etiquetado como MB02-C-02-17 ,
100 mg/4mL vial.
Concentrado para solucion/infusion
Sponsors
MABXIENCE RESEARCH S.L.,
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. To be eligible for study entry, subjects must satisfy all of the following criteria: 2. Males and female subjects aged 18 years to 80 years. 3. Signed informed consent must be obtained before initiation of any study-specific procedures or treatment as confirmation of the subject’s awareness and willingness to comply with the study requirements. 4. Subjects should have newly diagnosed or recurrent Stage IIIB/IV (defined by seventh edition of the TNM classification for Lung Cancer, 2010) non-squamous NSCLC not amenable to curative intent surgery, and not have received any systemic therapy for advanced disease (exclusion criteria 3 and 4). For subjects with recurrent disease, at least 6 months must have elapsed before randomization from previous adjuvant treatment. 5. Previous radiation therapy if completed >4 weeks before randomization. Palliative radiotherapy to bone lesions is allowed if completed >2 weeks of randomization.
Exclusion criteria
Exclusion criteria: Subjects will be excluded from the study if 1 or more of the following criteria are applicable: • Inability to comply with protocol procedures. • Participation in another clinical trial or treatment with another investigational agent within 4 weeks or 5 half-lives of investigational agent before randomization, whichever is longer. • Subjects previously treated with monoclonal antibodies or small molecule inhibitors against VEGF or VEGF receptors, including Avastin®. • Subjects who have received previous chemotherapy, immunotherapy, targeted therapy, or biological therapy for their lung cancer. Note: Adjuvant and neo-adjuvant therapy are permitted (see: inclusion criterion 3). Subjects who have known central nervous system disease, with the exception of subjects with treated brain metastases who have completed treatment (radiation, surgery or stereotactic surgery) and have not received steroids for at least 4 weeks before randomization. Subjects with central nervous system metastases treated by neurosurgical resection or brain biopsy performed within 8 weeks before randomization will be excluded. Subjects with known or history of brain metastases must undergo brain imaging during screening.
Countries
Brazil, Chile, Georgia, Greece, Hungary, India, Ivory Coast, Jordan, Lebano, Malasya, Mexico, Oman, Peru, Philippines, Russian Federation, Serbia, South Africa, Spain, Thailand, Turkey, Ukraine
Contacts
Public ContactNarda Malpartida
SYNEOS HEALTH PERU S.R.L.
Outcome results
None listed