Health Condition 1: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung Health Condition 2: null- Stage IIIB/IV Non-squamous Non-Small Cell Lung Cancer (NSCLC)
Conditions
Interventions
Intervention1: MB02 (Bevacizumab Biosimilar Drug) in Combination With Carboplatin and Paclitaxel: MB02 (bevacizumab biosimilar drug) to be administered as an IV infusion at an intended dose of 15 mg/k
Sponsors
mAbxience
Eligibility
Inclusion criteria
Inclusion criteria: 1. Males and female subjects aged >=18 years to 2. Signed informed consent must be obtained before initiation of any study-specific procedures or treatment as confirmation of the subjectâ??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 7. Subjects must have adequate hepatic, renal and hematologic function defined as: --Hepatic function: bilirubin level --Renal function: serum creatinine level 30 mL/min (Cockroft-Gault formula), urine protein to creatinine ratio 1 may be enrolled if they have -- Hematological function: Absolute neutrophil count >1.5Ã?109 /L; platelets >100Ã?109 /L, hemoglobin (Hb) >9 g/dL. -- Adequate coagulation parameters such as: INR anticoagulation therapy. 8. Eligible subjects must have a systolic blood pressure of 9. Women of childbearing potential, and their partners, must agree to adhere topregnancy prevention methods throughout the duration of the study (including the Follow-up visits, where applicable). Women of childbearing potential are defined as those who are not surgically sterile (did not underwent bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) and not postmenopausal. Subjects and their partners must agree to use a highly effective method of contraception, to avoid women becoming pregnant throughout the course of the study. Medically acceptable forms of birth control can include the following, with approval of the treating physician: -- Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral,intravaginal, or transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised partner, sexual abstinence. 10. Non fertile women can be included, that is, those who are physiologically incapable of becoming pregnant, because of: -- Hysterectomy. -- Bilateral oophorectomy (ovariectomy). -- Bilateral tubal ligation or, -- Postmenopausal women defined as: Subjects not using HRT and have experienced total cessation of menses for >=1 year and be gr
Exclusion criteria
Exclusion criteria: 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 angin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate: Objective response (OR) will be assigned for a subject if the subject displays either complete response (CR) or partial response (PR) per RECIST version 1.1Timepoint: 18 Weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of Safety profile (incidence, nature, and severity of adverse events (AEs) graded according to NCI-CTCAE; v4.03 Timepoint: Week 1 to week 52;To assess PFS and OS compared with those of Avastin®.Timepoint: at Week 18 and at Week 52;To assess the potential immunogenicity of MB02 compared with Avastin® assessed through determination of antidrug antibodies (ADA).Timepoint: Through 52 weeks after first study drug administration;Tumor AssessmentsTimepoint: At intervals of 6 weeks, from Cycle 1 Day 1 until the end of Cycle 6 (ie, 18 weeks after first study drug administration). after Cycle 6, tumor assessments will be performed at intervals of 9 weeks until evidence of disease progression and/or the start of new antitumor treatment, death, or Week 52 (End-of-Study Visit), whichever occurs first | — |
Countries
Brazil, Bulgaria, Chile, Georgia, Greece, Hungary, India, Jordan, Lebanon, Malaysia, Mexico, Oman, Peru, Philippines, Russian Federation, Serbia, South Africa, Spain, Thailand, Turkey, Ukraine
Contacts
Public ContactAbhishek Tyagi
Kendle India Pvt. Ltd.
Outcome results
None listed