Safety, tolerability and efficacy of bevacizumab (Zydus Cadila) in nonsmallcell lung cancer (NSCLC)

Phase 3

Completed

• Conditions: Health Condition 1: C349- Malignant neoplasm of unspecifiedpart of bronchus or lungHealth Condition 2: null- non-squamous non-small celllung cancer

• Registration Number: CTRI/2015/08/006109
• Lead Sponsor: Cadila Healthcare Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2017-03-23
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 248

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

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 �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 (�1/2 tsp red blood) or hematuria or hematemesis within 3 months

10. Absolute neutrophil count <1500/mm3

11. Platelets <100000/mm3

12. Creatinine level �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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of best overall response rate (ORR) following bevacizumab (Test Product, Zydus) <br/ ><br>and bevacizumab (Reference Product) treatment in patients with non-squamous non-small cell <br/ ><br>lung cancerTimepoint: Time Point :-Day 127

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics of bevacizumab following IV infusions of bevacizumab (Test Product, Zydus) <br/ ><br>and bevacizumab (Reference Product, Roche/Genentech) till Day 22 after cycle 6 with <br/ ><br>bevacizumab in patients with non-squamous non-small cell lung cancer (NSCLC) after single <br/ ><br>dose. <br/ ><br>To assess the safety, tolerability and immunogenicity of bevacizumab (Test Product, Zydus) and <br/ ><br>bevacizumab (Reference ProductTimepoint: Pharmacokinetics of bevacizumab following IV infusions of bevacizumab (Test Product, Zydus) <br/ ><br>and bevacizumab (Reference Product, Roche/Genentech) till Day 22 after cycle 6 with <br/ ><br>bevacizumab in patients with non-squamous non-small cell lung cancer (NSCLC) after single <br/ ><br>dose.