Stage IIIB/IV Non-squamous Non-Small Cell Lung Cancer Lung Cancer
Conditions
Interventions
Cycle 1 through Cycle 6 (Monoclonal Immnuglobulin therapy in combination with chemotherapy administered on Day 1 of every 3 week treatment cycle)
- Arm 1:
MB02 (bevacizumab biosimilar) IV at an intend
MB02 + Paclitaxel + Carboplatin
Avastin + Paclitaxel + Carboplatin
Avastin
Sponsors
mAbxience Research S.L.
One sponsor only
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria To be eligible for study entry, subjects must satisfy all of the following criteria: 1. Males and female subjects aged = 18 years to = 80 years. 2. 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. 3. 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. 4. Previous radiation therapy if completed >4 weeks before randomization. Palliative radiotherapy to bone lesions is allowed if completed >2 weeks of randomization. 5. Subjects must have at least 1 unidimensional measurable lesion per RECIST version 1.1 (assessed locally). 6. Subjects must have an ECOG performance status =1 at Screening. 7. Subjects must have adequate hepatic, renal and hematologic function defined as: ? Hepatic function: bilirubin level 30 mL/min (Cockroft-Gault formula), urine protein to creatinine ratio 1 may be enrolled if they have 1.5×109 /L; platelets >100×109 /L, hemoglobin (Hb) >9 g/dL. ? Adequate coagulation parameters such as: INR = 2.0 and aPTT = 1.5 x ULN within 7 days prior to randomization for patients not receiving anticoagulation therapy. 8. Eligible subjects must have a systolic blood pressure of = 140 mm Hg and a diastolic blood pressure of 40 mIU/
Exclusion criteria
Exclusion criteria: Exclusion Criteria Subjects will be excluded from the study if 1 or more of the following criteria are applicable: 1. Inability to comply with protocol procedures. 2. 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. 3. Subjects previously treated with monoclonal antibodies or small molecule inhibitors against VEGF or VEGF receptors, including Avastin®. 4. Subjects who have received previous chemotherapy, immunotherapy, targeted therapy, or biological therapy for their lung cancer. Note: Adjuvant and neoadjuvant therapy are permitted (see: inclusion criterion 3). 5. 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. 6. Current or recent (within 10 days of the first dose of study treatment) use of aspirin (at least 325 mg/day) or other nonsteroidal anti-inflammatory drugs with antiplatelet activity or treatment with dipyridamole (Persantine®), ticlopidine (Ticlid®), clopidogrel (Plavix®), or cilostazol (Pletal®). 7. Current or recent (within 5 days) use of therapeutic anticoagulation or use of thrombolytic agent. Prophylactic use of low molecular weight heparin is allowed. 8. Subjects with an INR >2, unless receiving active anticoagulation treatment, will be excluded. 9. Subjects who have a diagnosis of small cell carcinoma of the lung or squamous cell carcinoma of the lung. Mixed tumors should be categorized according to the predominant histology. If small cell elements are present, the subject will be excluded. 10. Subjects with known tumors that harbor activating epidermal growth factor receptor and anaplastic lymphoma receptor tyrosine kinase (assessed locally). 11. Subjects who have a history of hypersensitivity to the active substance (bevacizumab, carboplatin, and/or paclitaxel) or any of the excipients (such as trehalose dehydrate, sodium phosphate, or polysorbate 20). 12. Subjects with known active viral infection: hepatitis B, hepatitis C, or HIV. 13. Subjects who are pregnant or breastfeeding. Women of child-bearing potential must have a negative pregnancy test at Screening. 14. Subjects with previous major surgery, open biopsy, open pleurodesis, or significant traumatic injury within 4 weeks before randomization or those anticipated to require major surgery during the study. 15. Subjects who have had a core biopsy taken or have had another minor surgical procedure, excluding placement of vascular access device, closed pleurodesis, thoracentesis, and mediastinoscopy, within 1 week of randomization. 16. Subjects with a history of abdominal fistula, GI perforation, intra-abdominal abscess within 6 months of randomization. 17. Subjects with a nonhealing wound, active ulcer, or untreated bone fracture. 18. Subjects with previous history of hypertensive crisis or hypertensive encephalopathy. 19. Subjects with New York Heart Association Grade II or greater congestive heart failure, or angina, myocardial infarctio
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Name: Objective Response Rate ;Timepoints: Week 18 after intiation of treatment ;Measure: Recist 1.1 tumor assessment | — |
Secondary
| Measure | Time frame |
|---|---|
| Name: Safety profile of MB02 compared with Avastin® ;Timepoints: During study ;Measure: NCI-CTCAE; v4.03 ;Name: Potential immunogenicity of MB02 compared with that of Avastin®;Timepoints: During study ;Measure: Antidrug antibodies ;Name: Progression-free survival and Overall survival ;Timepoints: Week 18 and Week 52 ;Measure: Recist 1.1 tumor assessment | — |
Countries
Brazil, Bulgaria, Chile, Georgia, Greece, Hungary, India, Lebanon, Malaysia, Mexico, Peru, Philippines, Republic of Serbia, Russian Federation, South Africa, Spain, Thailand, Turkey, Ukraine
Contacts
Public ContactDr. Pavel Tyan
INC Research
Outcome results
None listed