CTRI/2015/08/006109 [Registered on: 19/08/2015] Trial Registered Prospectively
Last Modified On:
06/06/2022
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Biological
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
Safety, tolerability and efficacy of bevacizumab (Zydus Cadila) in nonsmall
cell lung cancer (NSCLC)
Scientific Title of Study
A Prospective, Randomized, Multi-Center Study to Compare the Safety,
Tolerability and Efficacy of Bevacizumab (Zydus Cadila) With
Bevacizumab (Avastin®) in Non-Small Cell Lung Cancer (NSCLC)
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
BEV.14.001.02.PROT, version 2.0 , dated 29th April 2015
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)
Name
Dr Deven Parmar
Designation
Vice president
Affiliation
Zydus Research Centre
Address
Zydus Research Center,
Survey No. 396/403, Sarkhej-Bavla National Highway No.8A
Moraiya,
Institute of Respiratory Diseases, SMS medical College and Attached Hospital, Subhash nagar shopping centre, shashtrinagar,Jaipur-302016
Jaipur RAJASTHAN
9829017619
dmkhippal@rediffmail.com
Aloke Ghosh Dastidar
IPGME&R, SSKM
Department for Radiotherapy
244, AJC Bose Road
Kolkata 700020 Kolkata WEST BENGAL
9831118494
alokeghoshdastidar@gmail.com
Dr Siddharth Basu
IPGME&R, SSKM
Department for Radiotherapy
244, AJC Bose Road
Kolkata 700020
Kolkata WEST BENGAL
Mandhaniya cancer Hospital and Research Institute, A-101, 1st floor, Neeti Gaurav Complex, 20 Central bazar Road, Adjacent to Hotel centre Point,Nagpur-440010
Nagpur MAHARASHTRA
9868315368
sushilnagpur001@yahoo.co.in
Dr Sunil Kumar
Om Research Centre
Om Research Centre, Om Surgical Center and Maternity Home,SA-17/3, P-4, Sri Krishna Nagar, Paharia, Ghazipur Road, Varanasi-221007,Uttar Pradesh,India
Varanasi UTTAR PRADESH
8127413678
sun.1980pgi@gmail.com
Dr Aniket Thoke
Sanjeevani CBCC Cancer Hospital
In front of Jain Mandir, Dawada colony,Pachpedi naka, Raipur, C.G. 492001 Raipur CHHATTISGARH
Supe Heart and diabetes Hospital and Research Centre
Supe Heart and diabetes Hospital and Research Centre, Opp. Adharashram, Gharpure Ghat, Near Rungtha School, Ashok Stambh,Nasik-422002
Nashik MAHARASHTRA
9823061929
drsulabhchandra@yahoo.co.in
Dr Asha S Aanand
The Gujarat Cancer and Research Institute
The Gujarat Cancer and Research Institute,NCH campus, Asarwa, Ahmadabad 380016
Ahmadabad GUJARAT
9924718992
gcriad1@bsnl.in
Dr Shamsuddin Virani
Unique hospital Multispeciality and Research Institute
Unique hospital Multispeciality and Research Institute,Opp. Kiran Motor,Near Canal Civil Hospital Char rasta Sosyo circle lane,off ring Road,Surat-395002,Gujarat
Surat GUJARAT
9879855522
virani13@gmail.com
Dr Prabagar Manickam
VGM Cancer Care
VGM Cancer Care (A unit of VGM Hospital), No. 2100, Trichy Road, Rajalakshmi mills stop,Coimbatore-641005
Coimbatore TAMIL NADU
(1) ICD-10 Condition: C349||Malignant neoplasm of unspecifiedpart of bronchus or lung, non-squamous non-small cell
lung cancer,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Bevacizumab (Reference Product, Avastin®)
Dosage:-Bevacizumab 15 mg/kg (IV infusion) plus paclitaxel 175 mg/m2 and carboplatin (AUC 5 mg/mL×min). Frequency:Day 01, Day 22, Day 43, Day 64, Day 85 and Day 106. route:-Intravenous
Intervention
Bevacizumab (Test-Zydus)
Dosage:-Bevacizumab 15 mg/kg (IV infusion) plus paclitaxel 175 mg/m2
and carboplatin (AUC 5 mg/mL×min).
Frequency:Day 01, Day 22, Day 43, Day 64, Day 85 and Day 106.
route:-Intravenous
Inclusion Criteria
Age From
18.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
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
ExclusionCriteria
Details
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 ≥1.5 × upper limit of normal (ULN)
14. Aspartate-aminotransferase(AST) and alanine-aminotransferase (ALT) levels ≥2.5 × ULN (≥5
× ULN for patients with liver metastases)
15. Alkaline phosphatase level ≥5 × 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
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 cancer
Time Point :-Day 127
Secondary Outcome
Outcome
TimePoints
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 Product
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.
Target Sample Size
Total Sample Size="222" Sample Size from India="222" Final Enrollment numbers achieved (Total)= "248" Final Enrollment numbers achieved (India)="248"
This is an A Prospective, Randomized, Multi-Center Study to Compare the Safety,Tolerability and Efficacy of Bevacizumab (Zydus Cadila) With Bevacizumab (Avastin®) in Non-Small Cell Lung Cancer (NSCLC) with Immunogenicity Assessment Extension study
The purpose of this study is to determine safety, tolerability, efficacy of bevacizumab (Test Product, Zydus) vs. bevacizumab (Reference Product, Roche/Genentech), in patients with unresectable, recurrent or metastatic non-squamous non-small cell lung cancer (NSCLC).