Health Condition 1: C343- Malignant neoplasm of lower lobe,bronchus or lung
Conditions
Interventions
Intervention1: BP01 (Bevacizumab): Concentrate for solution for infusion 400 mg/16 mL
Control Intervention1: Avastin®-EU: Concentrate for solution for infusion 400 mg/16 mL
Sponsors
CURATEQ BIOLOGICS PRIVATE LIMITED India
AXIS Clinicals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Signed informed consent obtained prior to initiation of any study specific procedures 2.Male and or female subjects aged 18 years to 70 years inclusive of both 3.Subjects with histologic or cytologic diagnosis of nsNSCLC with negative or unknown sensitizing epidermal growth factor receptor mutation and documented negative or unknown anaplastic lymphoma kinase translocation 4.Subjects with newly diagnosed or recurrent Stage IIIB or IV ns NSCLC 5.Subjects must have at least 1 Uni dimensional measurable target lesion as per RECIST v1.1 6.Subjects with ECOG PS 0 or 1 at the time of screening and prior to first infusion 7.Subjects who are newly diagnosed should not have received any prior chemotherapy or targeted therapy 8.Subjects should not have received any immunotherapy or biological therapy for their disease 9.Subjects received prior adjuvant chemotherapy for NSCLC is permitted if completed 6 months prior to randomization 10.Subjects received prior radiation therapy if completed 4 weeks prior to randomization 11.Subjects must have a baseline scan of the chest abdomen and other disease sites as clinically indicated to assess disease burden performed within 21 days prior to randomization 12.Subjects with life expectancy of at least 6 months 13.Subjects must have adequate hepatic renal and hematologic function defined as 14.Subjects who has liver and/ or bone metastasis must have adequate organ function 15.Female subjects of child-bearing potential must be non-lactating and have a negative serum pregnancy test at the time of screening 16.Female subjects of childbearing potential agree to pregnancy prevention throughout the duration of study 17.Female subjects must agree to use of an effective method of contraception during study like Barrier methods Intrauterine device Hormone contraceptives
Exclusion criteria
Exclusion criteria: 1. Inability to comply with protocol procedures. 2. Subjects in another clinical trial or treatment with another investigational agent within 4 weeks of randomization, or five half-lives of investigational agent if longer than 4 weeks. 3. Subjects with known hypersensitivity to the active ingredients or any of the excipients or Chinese Hamster Ovary (CHO) cell products, or other recombinant human or humanized antibodies and combination chemotherapy. 4. Subjects who are having Central Nervous System (CNS) disease including brain and spinal cord metastases. 5. Subjects are on corticosteroids therapy except as premedication (must be off corticosteroids for at least 4 weeks prior to randomization). 6. Subjects are on anticoagulation treatment for thromboembolism. 7. Subjects were previously treated with vascular endothelial growth factor receptor (VEGFR) directed therapy. 8. Subjects have predominantly squamous cell histology NSCLC and Small Cell Lung Cancer (SCLC). 9. Subjects have concomitant systemic disorder (Hepatitis B, Hepatitis C, or human immunodeficiency virus). 10. Female subjects who are pregnant or breastfeeding. 11. Subjects with prior major surgery, open biopsy, open pleurodesis, or significant traumatic injury within 4 weeks prior to randomization or have an anticipated need for major surgery during study. 12. Subjects having core biopsy, other minor surgical procedure, excluding placement of vascular access device, closed pleurodesis, thoracentesis, mediastinoscopy, taken within 1 week of randomization. 13. Subjects have history of stroke or transient ischemic attack with-in 6 months prior to randomization. 14. Subjects have prior history of hypertensive crisis or hypertensive encephalaopathy. 15. Subjects with previous malignancy within 5 years of randomization (other than superficial basal cell and superficial squamous cell cancer, or uterine, cervix, bladder, or prostate cancer). 16. Subjects with uncontrolled hypertension (defined as systolic blood pressure >150 and/or diastolic > 100 mm Hg on antihypertensive medications). 17. Subjects with clinically significant cardiovascular disease: history of myocardial infarction, angina, or heart disease by NYHA Class II, III, or IV, within 6 months prior to randomization 18. Subjects with a history of significant vascular event within 6 months prior to randomization (including, but not limited to myocardial infarction and stroke or transient ischemic attack). 19. Subjects with known bleeding diathesis or significant coagulopathy within 3 months prior to randomization. 20. Subjects with a history of abdominal fistula, gastro-intestinal perforation, intraabdominal abscess within 6 months of randomization. 21. Subjects with a non-healing wound, active ulcer, inflammatory bowel disease or untreated bone fracture. 22. Subjects with history of hemoptysis (approximately > 2.5 mL or a half teaspoon) within three months prior to randomization. 23. Subjects with tumour invading or compressing major blood vessels. 24. Subjects with history or presence of arterial/venous thromboembolic events. 25. Subjects with history or presence of Posterior Reversible Encep-halopathy Syndrome (PRES). 26. Subjects with presence of Osteonecrosis of the jaw. 27. Subjects with known current alcohol/ drugs of abuse th
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The overall response rate (ORR) assessed according to RECIST v1.1 at the completion of Induction phase. Primary efficacy assessment will be based on the investigators assessment and as well as the independent central radiological assessment results, but for the efficacy conclusion, data determined by an independent central radiological assessment will be considered.Timepoint: time point response will be Estimated at every 8 weeks during induction period | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free survival (PFS), Overall Survival (OS), Duration of Response (DOR) and Disease Control Rate (DCR), Safety Profile, Immunogenicity and population pharmacokinetics (Ctrough) of BP01 (Bevacizumab) as compared to Avastin®-EU.Timepoint: Response will be Estimated after 6th cycle | — |
Countries
Bosnia and Herzegovina, Bulgaria, Hungary, India, Macedonia, Russian Federation
Contacts
Public ContactDr Subhra Lahiri
AXIS Clinicals Ltd
Outcome results
None listed