Health Condition 1: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung Health Condition 2: null- non-squamous non-small cell lung cancer
Conditions
Interventions
Intervention1: Bevacizumab (Test-Zydus): Dosage:-Bevacizumab 15 mg/kg (IV infusion) plus paclitaxel 175 mg/m2
and carboplatin (AUC 5 mg/mLÃ?â??min).
Frequency:Day 01, Day 22, Day 43, Day 64, Day 85 an
Sponsors
Cadila Healthcare Limited
Eligibility
Inclusion criteria
Inclusion criteria: Patient of both sex aged � 18 years 2. Patient with history of histologically or cytologically confirmed non-squamous non-small cell lung cancer (defined as stage IIIB with malignant pleural effusion, stage IV, or recurrent disease) 3. Patients with advanced, unresectable or metastatic non-squamous NSCLC suitable for treatment with Bevacizumab, carboplatin and paclitaxel (BV and CP) therapy as a first line therapy 4. Bidimensionally measurable lesion according to RECIST 1.1 criteria 5. Patients with Eastern Cooperative Oncology Group (ECOG) performance status score of �2 6. Life expectancy of 12 weeks or more 7. Patients able to understand the investigational nature of this study and give written informed consent prior to the participation in the trial 8. Able to comply with study requirement in opinion of Principal Investigator
Exclusion criteria
Exclusion criteria: Pregnant and lactating women 2. Patient who have received prior chemotherapy or biotherapy, radiotherapy to an area measurable disease (unless disease progression is documented following completion of the therapy) or radiotherapy within past 2 weeks 3. History of clinically significant cardiac diseases (e.g., uncontrolled hypertension, myocardial infraction, unstable angina, NYHA ââ?°Â¥2 congestive heart failure, or serious cardiac arrhythmia) in past six months 4. History of serious or severe arterial thrombotic events and/or venous thromboembolic events (cerebral infarction, myocardial infarction, stroke, active symptomatic peripheral vascular disease; deep vein thrombosis, pulmonary embolism or proven coagulopathy in past three months. 5. Recent or current use of aspirin or oral and/or parental anticoagulants (except low dose Coumadin 1 mg), known hypersensitivity to any components of the study medications and ingredients 6. History of surgery in past 4 weeks or planned elective surgery, fine needle biopsy, or an open biopsy within past one week 7. Any other medical conditions (including mental illness, substance abuse, social situations) deemed by the clinician 8. Patients with CNS metastasis 9. Gross hemoptysis (ââ?°Â¥1/2 tsp red blood) or hematuria or hematemesis within 3 months 10. Absolute neutrophil count 11. Platelets 12. Creatinine level ââ?°Â¥1.5 mg/dL 13. Bilirubin level ââ?°Â¥1.5 Ã?â?? upper limit of normal (ULN) 14. Aspartate-aminotransferase(AST) and alanine-aminotransferase (ALT) levels ââ?°Â¥2.5 Ã?â?? ULN (ââ?°Â¥5 Ã?â?? ULN for patients with liver metastases) 15. Alkaline phosphatase level ââ?°Â¥5 Ã?â?? ULN Cadila Healthcare Limited CLINICAL TRIAL PROTOCOL BEV.14.001.02.PROT CONFIDENTIAL PAGE 7 OF 80 Prepared by: Dr. Jayeshkumar Bhatt Approved by: Dr. R. H. Jani Protocol No. BEV.14.001.02.PROT Version No.: 2.0 16. Patient with non-healing wounds, ulcers or bone fractures 17. History of serious and / or severe infections such as Hepatitis C virus, hepatitis B virus, HIV infections, tuberculosis, etc. 18. Simultaneous participation in other clinical trials, previous participation in other clinical trials within 3 months before entering into the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of best overall response rate (ORR) following bevacizumab (Test Product, Zydus) and bevacizumab (Reference Product) treatment in patients with non-squamous non-small cell lung cancerTimepoint: Time Point :-Day 127 | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics of bevacizumab following IV infusions of bevacizumab (Test Product, Zydus) and bevacizumab (Reference Product, Roche/Genentech) till Day 22 after cycle 6 with bevacizumab in patients with non-squamous non-small cell lung cancer (NSCLC) after single dose. To assess the safety, tolerability and immunogenicity of bevacizumab (Test Product, Zydus) and bevacizumab (Reference ProductTimepoint: Pharmacokinetics of bevacizumab following IV infusions of bevacizumab (Test Product, Zydus) and bevacizumab (Reference Product, Roche/Genentech) till Day 22 after cycle 6 with bevacizumab in patients with non-squamous non-small cell lung cancer (NSCLC) after single dose. | — |
Countries
India
Contacts
Public ContactDr Deven Parmar
Zydus Research Centre
Outcome results
None listed