Health Condition 1: null- Patients with inoperable or advanced non-squamous non-small-cell lung cancer.
Conditions
Interventions
Intervention1: BCD-021 (INN bevacizumab, CJSC BIOCAD, Russia): After signing the informed consent form and completing screening procedures, patients will be stratified depending on performance status
Sponsors
BIOCAD INDIA PVT LTD
Eligibility
Inclusion criteria
Inclusion criteria: 1. Written informed consent; 2. Newly diagnosed histologically or cytologically confirmed NSCLC excluding squamous NSCLC (mixed cancer types should be classified according to the prevalent cell type); 3. IIIb or IV stage of NSCLC (TNM classification version 6); 4. Age >= 18 years and age 5. ECOG performance status 0, 1 or 2, (not declining within 2 weeks prior to the first dose of investigational product); 6. Life expectancy - 12 weeks or more from the moment of randomization; 7. Presence of at least 1 measurable tumour with a size not less than 1 cm (revealed with CT slice thickness not more than 5 mm), as defined by modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria (specifically, no ascites, pleural, or pericardial effusions, osteoblastic bone metastases, or carcinomatous lymphangitis of the lung as only lesion; 8. Patients should be able to follow the Protocol procedures (according to Investigatorâ??s assessment); 9. Patients must implement reliable contraceptive measures during all the study treatment, starting 4 weeks prior to the administration of the first dose of investigational product until 6 months after the last dose of investigational product. This requirement does not apply to participants who have undergone surgical sterilization, or patients who are postmenopausal (documented) for the past 2 years. Reliable contraceptive measures include two methods of contraception, including one barrier method.
Exclusion criteria
Exclusion criteria: 1. Squamous NSCLC; 2. Proven coagulopathy, clinically significant hemorrhage in the past including nasal hemorrhage; 3. ANC (absolute neutrophil count) 4. Platelets 5. Hemoglobin 6. Creatinine level >=1.5 mg/dL; 7. Bilirubin level >=1.5 Ã? upper limit of normal (ULN); 8. AST and ALT levels >=2.5 Ã? ULN (>=5 Ã? ULN for patients with liver metastases); 9. Alkaline phosphatase level >=5 Ã? ULN; 10. Current therapeutic anticoagulation treatment, aspirin (more than 325 mg/day), NSAIDs, antiplatelet agents or protracted treatment with these drugs less than 1 month before entering the study; 11. Uncontrolled hypertension comprising all cases of arterial hypertension when no decrease in blood pressure could be achieved despite treatment with a combination of 3 antihypertensive drugs including one diuretic and non-medical correction methods (low salt diet, physical exercise); 12. Any previous anticancer therapy (chemotherapy, radiation therapy, surgery etc.) of metastatic NSCLC; 13. Radiation or hormone therapy within 21 days prior to randomization; 14. Major surgery 28 days before inclusion into the study; 15. Previous antiangiogenic therapy; 16. Hypersensitivity to taxanes, platinum agents, recombinant murine proteins, contrast agents, premedication agents specified by Protocol (dexamethasone, diphenhydramine, ranitidine) or excipients of investigational products; 17. CNS metastases excluding metastases non-progressing without glucocorticosteroids within 4 weeks before inclusion into the trial; 18. Cardiovascular system pathology (CHF stage III-IV according to NYHA classification); 19. Pregnancy or lactation; 20. Conditions limiting patientâ??s adherence to Protocol requirements (dementia, neurologic or psychiatric disorders, drug addiction, alcoholism and others); 21. Stage II-IV neuropathy according to CTCAE v.4.03; 22. Simultaneous participation in other clinical trials, previous participation in other clinical trials within 30 days before entering into the trial, previous participation in the same trial; 23. Any other concomitant cancer revealed within 5 years prior to screening, except curatively treated intraductal carcinoma in situ, curatively treated cervical carcinoma in situ or curatively treated basal cell or squamous cell carcinoma; 24. Acute or active chronic infections; 25. HCV, HBV, HIV, or syphilis infections; 26. Obstacles in intravenous administration of study drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The therapy efficacy will be evaluated using contrast-enhanced computed tomography (CT) data. Contrast-enhanced CT will be performed at screening, after 3 therapy cycles and after 6 therapy cycles. If a complete or partial response is shown by CT after 3 or 6 therapy cycles, an additional CT will be performed after 4 weeks (28±3 days) to confirm the results.All CT results will be sent to CJSC BIOCAD.Timepoint: Contrast-enhanced CT will be performed at screening, after 3 therapy cycles and after 6 therapy cycles | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Efficacy evaluation 2. Safety Evaluation 3. Pharmacokinetics Evaluation Timepoint: PK- 0, 1.5 ,3 ,4.5, 6, 24,96,168,336, 504,prior to 3rd inf,prior to 4th inf, prior to 5th inf, prior to 6th inf, 1.5, 3,4.5,6, 24,96, 168, 336 and 504 after 6th infusion Efficacy -Contrast-enhanced CT will be performed at screening, after 3 therapy cycles and after 6 therapy cycles | — |
Countries
India
Contacts
Public ContactDr Mrutyunjaya Ganiger
BIOCAD INDIA PVT LTD
Outcome results
None listed