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CTRI Number  CTRI/2019/08/020665 [Registered on: 09/08/2019] Trial Registered Prospectively
Last Modified On: 09/06/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to compare the efficacy and safety of INTP24 against Avastin® in patients with lung cancer. 
Scientific Title of Study   A randomized, double-blind, multicentre, multinational comparative clinical study to compare the efficacy and safety of INTP24 against Avastin® in patients with unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer. 
Trial Acronym   
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
0586-18, Version no. 1.1, Date: 25 Jul 2019  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mr Prashant Modi 
Designation  General Manager 
Affiliation  Lambda Therapeutic Research Ltd 
Address  Lambda House, Department of Project Management & Regulatory Affairs, Plot No. 38, Survey No. 388
Near Silver Oak Club, S. G. Highway, Gota
Ahmadabad
GUJARAT
382481
India 
Phone  07940202375  
Fax  07940202021  
Email  prashantmodi@lambda-cro.com  
 
Details of Contact Person
Scientific Query

Modification(s)  
Name  Dr Naman Shah 
Designation  General Manager 
Affiliation  Lambda Therapeutic Research Ltd 
Address  Lambda House, Department of CTM Medical Services, Plot No. 38, Survey No. 388
Near Silver Oak Club, S. G. Highway, Gota
Ahmadabad
GUJARAT
382481
India 
Phone  07940202389  
Fax  07940202021  
Email  namanshah@lambda-cro.com  
 
Details of Contact Person
Public Query
 
Name  Mr Prashant Modi 
Designation  General Manager 
Affiliation  Lambda Therapeutic Research Ltd 
Address  Lambda House, Department of Project Management & Regulatory Affairs, Plot No. 38, Survey No. 388
Near Silver Oak Club, S. G. Highway, Gota
Ahmadabad
GUJARAT
382481
India 
Phone  07940202375  
Fax  07940202021  
Email  prashantmodi@lambda-cro.com  
 
Source of Monetary or Material Support  
Intas Pharmaceuticals Ltd. (Biopharma Division), Plot No: 423/P/A, Sarkhej-Bavla Highway, Moraiya, Sanand, Ahmedabad, Gujarat, India 382213. Tel: 02717660100, Fax: 02717660105 
 
Primary Sponsor  
Name  Intas Pharmaceuticals Ltd Biopharma Division 
Address  Plot No: 423/P/A, Sarkhej-Bavla Highway, Moraiya, Sanand, Ahmedabad, Gujarat, India 382213. Tel: 02717660100, Fax: 02717660105 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NA  NA 
 
Countries of Recruitment     India
Germany
Poland
Romania
Spain  
Sites of Study
Modification(s)  
No of Sites = 57  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ajay Sharma  Action Cancer Hospital   Department of clinical research,Room No NA,A-4, Paschim Vihar - 110063
New Delhi
DELHI 
09999379838

ajaysharma04@rediffmail.com 
Dr Rambha Pandey  All India Institute of Medical Sciences  Department of clinical research, Room No. NA,Ansari Nagar, East, Gautam Nagar - 110029.
New Delhi
DELHI 
09310012026

rambha151@gmail.com 
Dr Saroj Kumar Das Majumdar  All India Institute of Medical Sciences  Department of Radiotherapy,Sijua, Patrapada, Po- Dumduma, Bhubaneswar-751019,
Khordha
ORISSA 
09438884066

sarojmajumdar@gmail.com 
Dr Prashant Mehta  Asian Institute of Medical Sciences  Department of clinical research, Room No NA,Sector 21A, Near Badkal Flyover Road -121001,
Faridabad
HARYANA 
09013590847

prashantcipher7@gmail.com 
Dr Arun Kumar L  Care Hospital  Department of clinical research, Room No NA,Hi-Tech City, Old Mumbai Highway, Near Cyberabad Police Commissionerate-500032
Hyderabad
TELANGANA 
07382348479

arunreddy.thipparthi@carehospitals.com 
Dr Padmaj S Kulkarni  Deeenanath Mangeshkar Hospital and Research Centre  Department of clinical research, Room No NA,Erandwane-411004
Pune
MAHARASHTRA 
09923391255

drpskoncologist@gmail.com 
Dr Pragnya Shukla  Delhi State Cancer Institute  Department of clinical research, Room No NA,Dilshad Garden, East-110095
East
DELHI 
09560390107

pragyaonco@gmail.com 
Dr Ashish Singhal  Dr. Ram Manohar Lohia Institute of Medical Sciences  Department of Surgical Oncology,Room No NA, Vibhuti Khand, Gomtinagar,- 226010
Lucknow
UTTAR PRADESH 
09453077109

ashishpgi@yahoo.co.in 
Dr K Velavan  Erode Cancer Centre  Department of clinical research, Room No 1/393, Velavan Nagar, Perundurai Road, Thindal-638012,
Erode
TAMIL NADU 
09842334222

kvels@rediffmail.com 
Dr Ashok Kumar Diwan  Government Medical College & Hosiptal,  Department of clinical research, Room No NA,Medical Square road-440003,
Nagpur
MAHARASHTRA 
09822816608

tinuad76@gmail.com 
Dr Ashish Kaushal  HCG Cancer Centre  Department of clinical research, Room No Sola-Science City Road, Near Sola Bridge, S.G. Highway-380060
Ahmadabad
GUJARAT 
09978297842

drashish4@yahoo.co.in 
Dr VS N Rao  HCG City Cancer Centre  Department of clinical research, Room No 33-25-33,Ch Venkata Krishnayya street, suryarao pet, Vijayawada-520002
Krishna
ANDHRA PRADESH 
09849121050

vsnrao@yahoo.co.in 
Dr Rajnish Nagarkar  HCG Manavata Cancer Centre  Department of clinical research, Room No NA Behind Shivang Auto,Mumbai Naka-422001
Nashik
MAHARASHTRA 
09823061929

drraj@manavatacancercentre.com 
Dr Vijay Aditya  HCG Pinnacle Cancer Centre,  Department of clinical research, Room No NA ,Plot No 10, Survey No: 13P, APIIC,Health City, Chinagadili-530040
Visakhapatnam
ANDHRA PRADESH 
07675945176

yvamail@gmail.com 
Dr Kakali Choudhury  Health Point Hospital  Department of clinical research, Room No 21, Prannath Pandit Street, Opposite Lansdowne Padmapukur-700025
Kolkata
WEST BENGAL 
09883083052

mailkakalichoudhury@gmail.com 
Dr Narendra Khippal  Institute of Respiratory Diseases, SMS Medical College and Hospital  Department of clinical research, Room No,B-2 Subhash Nagar Shopping Center, Shashtri Nagar-302016
Jaipur
RAJASTHAN 
09829017619

drnkhippal@rediffmail.com 
Dr Mangesh Mekha  Jehangir Clinical Development Centre Pvt. Ltd.  Department of clinical research, Room No NA,Jehangir Hospital Premises, 32 sassoon road-411001,
Pune
MAHARASHTRA 
08149364641

mangesh.mekha@gmail.com 
Dr Guru Prasad Mohanty  Kailash Cancer Hospital and Research Centre  Department of clinical research, Room No NA,Muni Seva Ashram, Goraj, Waghodia-391760
Vadodara
GUJARAT 
09427432383

Guru.prasad@greenashram.org 
Dr Rajendra Kumar  King Georges Medical University  Department of Radiotherapy, Shah Mina Rd, Chowk,Shatabdi Phase II-226003
Lucknow
UTTAR PRADESH 
09369918180

drrkumar10@gmail.com 
Dr S P Shrivastav  Kiran Hospital Multi Super Speacility Hospital and Research center  Department of clinical research, Room No NA,Vasta Devdi Roadnear sumul dairy,Katargam,--395004
Surat
GUJARAT 
09824196710

communication@kiranhospital.com 
Dr Mahesh Kumar Kalloli  KLES Dr. Prabhakar Kore Hospital & MRC  Department of clinical research, Room No NA,Nehru Nagar, Belgavi-590010,
Belgaum
KARNATAKA 
09945014996

mahesh.kalloli@gmail.com 
Dr Rashmi Anand Gudur  Krishna Institute of Medical Sciences   Pune-Banglore Highway-4, Department of clinical research, Room No: NA, Malkapur, Karad-415110
Satara
MAHARASHTRA 
9860249027

rashmiagudur@gmail.com 
Dr Rakesh Reddy  Mahatma Gandhi Cancer Hospital & Research Institute  Department of clinical research, Room No 1/7,MVP Colony-530017
Visakhapatnam
ANDHRA PRADESH 
09013355935

drrakeshreddyboya@yahoo.com 
Dr Manu Prasad  Malabar Cancer Centre  Department of clinical research, Room No NA,Moozhikara, Kodiyeri, Thalassery-670103
Kannur
KERALA 
08589957229

manuprasadmcc@gmail.com 
Dr Balaji Shewalkar  Marathwada Regional Cancer Centre & Research Institute  Department of clinical research, Room No NA,Near Jama Masjid, Aam Khas Maidan Road-431001
Aurangabad
MAHARASHTRA 
09850632639

drbalajishewalkar@gmail.com 
Dr Gautam Goyal  Max Super Speciality Hospital  Mohali-A, Unit of Hometrail Buildtech Pvt. Ltd.,Near Civil Hospital,Phase-6,Mohali-160055
Rupnagar
PUNJAB 
08195849111

gautam3636@gmail.com 
Dr Kirushna Kumar Kosanam Subramanian  Meenakshi Mission Hospital & Research Centre  Department of clinical research, Room No NA,Lake Area, Melur Road-625107
Madurai
TAMIL NADU 
09787713004

drkskk@yahoo.com 
Dr Mukul Goyal  Metro Asian Cancer Research Institute,Metro Mas Hospital  Department of clinical research, Room No NA Shipra Path, Near Technology Park, Mansarovar-302020
Jaipur
RAJASTHAN 
09530370043

drmukulgoyal@yahoo.in 
Dr Suman Kalyan  MIOT International Multi Speciality Hospital  Department of clinical research, Room No 4/112, Mount Poonamalle High Road, Manapakkam -600089
Chennai
TAMIL NADU 
07708866883

mailsumankalyan@gmail.com 
Dr Parimkayala Radhika  MNJ Institute of Oncology & Regional Cancer Centre  Red Hills-500004, India
Hyderabad
TELANGANA 
9848792682

radhika.parimkayala@gmail.com 
Dr Ashish Joshi  Mumbai Oncocare Centre  Department of clinical research, Room No NA 2nd Floor, Majithia Apartments, Gods gift premises Co.op.Soc.Ltd, S.V.Road, Vileparle(W)-400056
Mumbai
MAHARASHTRA 
09167009042

ashjoshi44@mocindia.co.in 
Dr Bhushan Nemade  Navsanjeevani Hospital (Sankalp Speciality Healthcare Pvt. Ltd.)  Plot No.8, Department of clinical research, Room No NA, Motkari Nagar, Behind Tupsakbare Lawns, Tidke Colony, Mumbai Naka-422002
Nashik
MAHARASHTRA 
9766126162

drtnemade@yahoo.co.in 
Dr Ghanshyam Patel  Nirmal Hospital Pvt. Ltd.  Department of clinical research, Room No NA, Ring Road-395002,
Surat
GUJARAT 
9376913131

drgnpatelonco@gmail.com 
Dr Amol Dumbare  Noble Hospital Pvt. Ltd  Department of clinical research, Room No 153,Magarpatta City Road-411013
Pune
MAHARASHTRA 
09970410590

dramol2003@yahoo.com 
Dr Deepak Kumar Mandal  North East Cancer Hospital and Research Institute  Department of clinical research, Room No NA,11th Mile, Amerigog, Jorabar,Guwahati,781023
Kamrup
ASSAM 
09435004872

mandal.dk69@yahoo.com 
Dr Rakesh neve  P.D.E.A.s, Ayurved Rugnalaya & Sterling Multispeciality Hospital  Department of clinical research, Room No NA,Sector No. 27, Near Bhel Chowk, Nigdi Pradhikaran,-411044
Pune
MAHARASHTRA 
09881143140

rakesh.neve23@gmail.com 
Dr K R Madhava  Prakriya Hospital  Department of clinical research, Room No NA,Service Road , 8th Mile , Nagasandra-560073
Bangalore
KARNATAKA 
09686724368

krmadhava1@gmail.com 
Dr Adwite Gore  Prince Aly Khan Hospital, Aga Hall  Department of clinical research, Room No NA,Nesbit Road,Mazagaon-400010,
Mumbai
MAHARASHTRA 
09821262618

adygore@gmail.com 
Dr Ullas Batra  Rajiv Gandhi Cancer Institute and Research Centre  Department of clinical research, Room No NA,Rohini, Sector-5-110085
New Delhi
DELHI 
09711080001

ullasbatra@gmail.com 
Dr Vaibhav Choudhary  Rashtra Sant Tukdoji Regional Cancer Hospital & Research Centre  Department of clinical research, Room No NA,Manewada Square, Tukdoji Square-440027
Nagpur
MAHARASHTRA 
09833621049

dr.vaibhav155@gmail.com 
Dr Dinesh Kumar Sinha  Regional Cancer Center, Indira Gandhi Institute of Medical sciences  Department of clinical research, Room No NA,Sheikhpura - 800014
Patna
BIHAR 
09771433132

drdineshkumarsinha@gmail.com 
Dr Minish Jain  Ruby Hall Clinic  Department of clinical research, Room No 40, Sassoon Road-411001,
Pune
MAHARASHTRA 
09823133390

minishjain009@gmail.com 
Dr Abhishek Kakroo  Sangini Hospital  Department of clinical research, Room No 1st floor and office No. 708, Santorini Square, B/H, Abhishree complex, opp. Star bazar, Nr. Jodhpur cross roads, satelite-380015
Ahmadabad
GUJARAT 
09974911291

kakrooabhishek@yahoo.com 
Dr Aniket Thoke  Sanjeevani CBCC USA Cancer Hospital  Department of clinical research, Room No NA,Infront of Jain Mandir Dawada Colony Pachpedi Naka- 492001
Raipur
CHHATTISGARH 
09752929741

drthoke@gmail.com 
Dr Akash Tiwari  Shalby Hospital Indore  Department of clinical research, Room No Part 5 & 6, R.S. Bhandari Marg , Near Janjeerwala,Square-452003
Indore
MADHYA PRADESH 
09968721696

akash07tiwari@gmail.com 
Dr Tushar Patil  Shree Hospital   Department of clinical research, Room No NA,Siddharth Mansion nagar-411006
Pune
MAHARASHTRA 
09552522556

tussipats@hotmail.com 
Dr Ghanshyam Biswas  Sparsh Hospital & Critical Care(P) Ltd.  Department of clinical research, Room No A/407, Saheed Nagar, Bhubaneswar, 751007
Khordha
ORISSA 
09937500878

drgbiswas@gmail.com 
Dr Suresh Sudaliandi  Sri Ramachandra Medical Center  Department of clinical research, Room No 13, East Spur Tank Road, Chetpet-600031,
Chennai
TAMIL NADU 
09841217666

drsureshonco@gmail.com 
Dr Lokanatha Dasappa  Sri Venkateshwara Hospital,  Department of clinical research, Room No # 86, Hosur Main Road, Madiwala- 560068
Bangalore
KARNATAKA 
09845695589

drlok61@gmail.com 
Dr Rajendra Arora  Sujan Surgical Cancer Hospital & Amravati Cancer Foundation  Department of clinical research, Room No 52/B Shankar Nagar, Main Road-444606
Amravati
MAHARASHTRA 
09823097973

dr_rsarora@rediffmail.com 
Dr S H Advani  Sushrut hospital & Research Centre  Department of clinical research, Room No NA,Chambur(E), 365 Swastik Park, 400071
Mumbai
MAHARASHTRA 
09821157706

shadvani2000@yahoo.com 
Dr Bhavesh Poladia  Thangam Hospital and Thangam Cancer,  Department of clinical research, Room No 54, Dr.Sankaran Road, Near BSNL Office, K K Nagar,-637001
Namakkal
TAMIL NADU 
09819151554

bhaveshpoladia@gmail.com 
Dr Kiran Kattimani  The Karnataka Cancer Therapy & research Institute, Padmashree, Dr. R. B. Patil Cancer Hospital  Padmashree, Department of clinical research, Room No NA, Dr. R. B. Patil Cancer Hospital,Navanagar,Hubli-580025
Dharwad
KARNATAKA 
9480616656

kctrihubli@gmail.com 
Dr Tanveer Maksud  Unique Hospital-Multispecialty & Research Institute  Department of clinical research, Room No NA,opp. Kiran Motor, Near canal road, Civil Char Rasta, Sosyo Circle Lane-395002
Surat
GUJARAT 
09909918887

tanveermaksud@gmail.com 
Dr P Vijaya Veeran  Universal cancer Hospital Limited  No.-370, Department of clinical research, Kondalampathy Roundana-630010
Salem
TAMIL NADU 
9843535362

drvijayaveeran@gmail.com 
Dr Amit Jain  Valentis Cancer Hospital  Department of clinical research,Room No NA,Mussoorie, Mawana Road, -250001
Meerut
UTTAR PRADESH 
09410816252

dramit2001@gmail.com 
Dr Nikhil Ghadyalpatil  Yashoda Hospital  Department of clinical research, Room No NA,Raj Bhavan Road, Soamjiguda-500082
Hyderabad
TELANGANA 
08008037474

nikhilghadyal@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 57  
Name of Committee  Approval Status 
Amravati Ethics Committee Sujan Surgical Cancer Hospital and Amravati Cancer Foundation,Dr Rajendra Arora  Approved 
Asian Institute of Medical Sciences Ethics Committee,Dr. Prashant Mehta  Approved 
Care Hospital, Institutional Ethics Committee,Dr. Arun Kumar L  Approved 
Delhi State Cancer Institute IEC ,Dr. Pragya Shukla  Approved 
Ethics Committee - Sterling Hospital ,Dr. Rakesh Neve  Approved 
Ethics Committee of SMS Medical College & Attached Hospital,,Dr. Narendra Khippal  Approved 
Ethics Committee V S Hospital ,Dr. Suresh Sudalaiandi  Approved 
Ethics Committee, HCG Pinnacle Oncology Pvt. Ltd.,Dr Vijaya Aditya  Approved 
Ethics Committee, Sanjeevani Cancer Hospital,Dr. Aniket Thoke  Approved 
Ethics Committee, Shalby Hospital Indore, Dr. Akash Tiwari  Approved 
Ethics Committee, Shree Hospital,Dr. Tushar Patil  Submittted/Under Review 
Ethics Committee, Unique Hospital- Multispeciality & Research Institute,Dr. Tanveer Maksud  Approved 
Ethics Committee,All India Institute of Medical Sciences,Dr. Rambha Pandey  Approved 
Ethics Committee,Jehangir Clinical Development Centre Pvt. Ltd,Dr. Mangesh Mekha  Approved 
Ethics Committee,Nirmal Hospital Pvt. Ltd, Dr. Ghanshyam Patel  Approved 
HCG Multispeciality Ethics Committee,HCG Multi Speciality Hospital,Dr. Ashish Kaushal  Approved 
Health Point Ethics Committee, Dr. Kakali Choudhury  Approved 
Institutional Ethics Commiittee of Krishna Institute of Medical Sciences, Dr. Rashmi Anand Gudur  Approved 
Institutional Ethics Committee Meenakshi Mission Hospital & Research Centre,Dr. Kirushna Kumar Kosanam Subramanian  Approved 
Institutional Ethics Committee ,Malabar cancer Centre, Dr. Manu Prasad  Approved 
Institutional Ethics Committee ,Universal Hospital (A Unit of Universal Cancer Hospital Limited),Dr. P. Vijaya veeran  Approved 
Institutional Ethics Committee Government Medical college,Dr. Balaji Shewalkar  Approved 
Institutional Ethics Committee King Georges Medical University,,Dr. Rajendra Kumar  Submittted/Under Review 
Institutional Ethics Committee, Dr. A P J Abdul Kalam Education & Research Centre ,Dr. S H Advani  Approved 
Institutional Ethics Committee, Dr. Ram Manohar Lohia Institute of Medical Sciences,Dr. Ashish Singhal  Approved 
Institutional Ethics Committee, Indira Gandhi Institute of Medical Sciences, Dr Dinesh Kumar Sinha  Approved 
Institutional Ethics Committee, KAHER, JNMC Campus ,Dr. Mahesh Kumar Kalloli   Approved 
Institutional Ethics committee, Noble Hospital Pvt. Ltd., Dr. Amol Dumbare  Approved 
Institutional Ethics Committee, Prince Aly Khan Hospital,Dr. Adwite Gore  Approved 
Institutional Ethics Committee, Rashtra Sant Tukdoji Regional Cancer Hospital & Research Centre,Dr. Vaibhav Choudhary  Approved 
Institutional Ethics committee, Valentis Cancer Hospital,Dr. Amit Jain  Approved 
Institutional Ethics Committee,Action Cancer Hospital,Dr. Ajay Sharma  Approved 
Institutional Ethics Committee,All India Institute of Medical Sciences, Dr. Saroj Kumar Das Majumdar  Approved 
Institutional Ethics Committee,deenanath Mangeshkar Hospital and Research Centre,,Dr. Padmaj S. Kulkarni  Submittted/Under Review 
Institutional Ethics Committee,Dr. Bhavesh Poladia  Approved 
Institutional Ethics Committee,Erode Cancer Centre,Dr. K. Velavan  Approved 
Institutional Ethics Committee,GMC,Dr. Ashok Kumar Diwan  Approved 
Institutional Ethics Committee,HCG Curie City Cancer Centre,Dr. V.S. N. Rao  Approved 
Institutional Ethics Committee,Kailash Cancer Hospital and Research Centre,Dr. Guru Prasad Mohanty  Approved 
Institutional Ethics Committee,MahaMahatma Gandhi Cancer Hospital & Research Institute,Dr. Rakesh Reddy  Approved 
Institutional Ethics Committee,Max Super speciality Hospital,Dr. Gautam Goyal  Approved 
Institutional Ethics Committee,North East cancer hospital and Research Institution,Dr. Deepak Kumar Mandal  Approved 
Institutional ethics committee,Sparsh hospital,Dr. G. Biswas  Approved 
INSTITUTIONAL ETHICS COMMITTEE,THE KARNATAK CANCER THERAPY AND RESEARCH INSTITUTE, Dr. Kiran Kattimani  Approved 
Institutional Ethics Committee,Yashoda Hospital,Dr. Nikhil Ghadyalpatil  Approved 
Institutional Review Board Rajiv Gandhi Cancer Institute and Research Centre, Dr. Ullas Batra  Submittted/Under Review 
Kiran Hospital Ethics Committee, Dr. S P Shrivastav  Approved 
Manavata Clinical research Institute Ethics Committee,Dr. Rajnish Nagarkar  Approved 
Metro-ACRI Ethics Committee, Metro Mas Hospital, Dr Mukul Goyal  Submittted/Under Review 
MIOT Institutional Ethics Committee,Dr. Suman Kalyan  Approved 
MNJ Institute of Oncology & Regional Cancer Centre Ethics Committee, Dr. Parimkayala Radhika  Approved 
Mumbai Oncocare Centre, Institutional Ethics Committee, Dr. Ashish Joshi  Approved 
Navsanjeevani Hospital Ethics Comminee, Dr. Bhushan Nemade  Approved 
People Tree Hospitals Ethics Committee,Dr K R Madhava  Approved 
Poona Medical Research Foundation, Institutional Ethics Committee,Dr. Minish Jain  Approved 
Sangini Hospital Ethics Committee,Dr.Abhishek Kakroo  Approved 
Sri Venkateshwara Hospital Ethics Committee, Dr Lokanatha Dasappa   Approved 
 
Regulatory Clearance Status from DCGI
Modification(s)  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C349||Malignant neoplasm of unspecifiedpart of bronchus or lung,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Avastin of Roche Registration Limited, United Kingdom  Dose: 15 mg/kg on day 1 of each 21-day chemotherapy cycle; Frequency: every 3 weeks (18 cycles); Mode of Administration: Intravenous infusion; Duration of treatment: 54 weeks 
Intervention  INTP24 Of Intas Pharmaceuticals Ltd., India  Dose: 15 mg/kg on Day 1 of each 21-day chemotherapy cycle; Frequency: every 3 weeks (18 cycles); Mode of Administration: Intravenous infusion; Duration of treatment: 54 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Patient of either gender and aged greater than or equal to 18 years
2. Patient having histologically or cytological confirmed predominately nonsquamous, non-small cell lung cancer.
3. Patients with locally advanced, unresectable or metastatic non-small cell lung cancer or recurrent non-small cell lung cancer according to The Union for International Cancer Control (UICC) staging system.
4. At-least one measurable lesion according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 or higher criteria.
5. For patients with recurrent disease, at least 6 months must have elapsed since
completing adjuvant or neoadjuvant treatment
6. ECOG performance status less than or equal to 2.
7. Patient should be eligible to receive study treatment of bevacizumab, paclitaxel, and carboplatin for the treatment of locally advanced or recurrent or metastatic non-squamous NSCLC.
8. Patient must have an adequate bone marrow, renal and hepatic function
9. Women of childbearing potential and partners of sexually active males must agree to use an accepted and effective method of contraception (oral, transdermal, or implanted contraceptives [any hormonal method in conjunction with a
secondary method], intrauterine device, female condom with spermicide, diaphragm with spermicide, absolute sexual abstinence, / and if males, absolute sexual abstinence, use of condom with spermicide by sexual partner or
temporarily sterile [at least 6 months prior to study drug administration] sexual partner) for the duration of the study and for at least 6 months after the last dose of the study treatment or permanently sterile.

Female patients who are not of childbearing potential should have undergone a documented hysterectomy and/or bilateral oophorectomy or have achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause (status may be confirmed at Investigator discretion by having a serum follicle stimulating hormone (FSH) level)
10. Patients able to understand the investigational nature of this study and give
written informed consent prior to the participation in the trial and able to comply
with study requirement in the opinion of Principal Investigator. 
 
ExclusionCriteria 
Details  1. Patient who has documented evidence of sensitizing epidermal growth factor receptor (EGFR) mutations or EML4-ALK translocation positive mutations.
2. Prior systemic therapy for non-small cell lung cancer (adjuvant or neoadjuvant therapy in case of recurrent disease will be allowed).
3. Prior immunotherapy or bevacizumab therapy.
4. Concurrent treatment with other anticancer therapies (excluding that defined in the protocol). Bone directed therapies like bisphosphonates and denosumab will be allowed.
5. Pregnant and breast-feeding women. Male patients with current pregnant partners will not be eligible.
6. History of local radiation therapy for bone metastases within last 1 month prior to the day of randomization.
7. Patients with a history of gross haemoptysis (defined as bright red blood of 1/2 teaspoon (2.5 ml) or more) or haemorrhage within last 3 months
8. Evidence of bleeding diathesis or coagulopathy (in the absence of therapeutic
Anticoagulation)
9. Current or recent (within 10 days of randomization) use of aspirin (greater than 325 mg/day) or treatment with dipyramidole, ticlopidine, clopidogrel, and cilostazol
10. Current use of oral or parenteral anticoagulants or thrombolytic agents for
therapeutic purposes that has not been stable for greater than 2 weeks prior to randomization
and INR/aPTT is within therapeutic limits (as per the local medical standards)
11. Therapeutic anticoagulation and/or coagulation abnormalities (e.g., INR greater than 1.5 and aPTT greater than ULN unless on prophylactic anticoagulation).
12. Patient with known brain metastases. A CT/MRI brain is required to confirm if it
was not done within 4 weeks prior to study entry.
13. Patients with non-healing wound ulcer, or bone fracture, or major surgical procedure, open biopsy, or significant traumatic injury within last 28 days or anticipation of need for major surgical procedure during the study.
14. Patients with history of gastrointestinal perforation, tracheoesophageal fistula or any grade 4 fistula
15. Patients with clinically significant cardiac diseases like New York Heart Association (NYHA) Grade II or greater, congestive heart failure (multigated acquisition [MUGA] or echocardiogram [ECHO]), unstable angina pectoris, myocardial infarction, cardiac arrhythmia, cerebral infarction, or transient ischemic attacks.
16. Uncontrolled hypertension (systolic blood pressure [BP] greater than 140 or diastolic BP
greater than 90 mmHg) (Patients with hypertension controlled by antihypertensive therapies are eligible).
17. Patients with a prior history of hypertensive crisis and hypertensive encephalopathy
18. Patient with ongoing or active infection (patient should be off anti-infective to be
eligible for participation).
19. A known case of or positive test for human immunodeficiency virus (HIV) infection or hepatitis B or hepatitis C virus (HCV).
20. History of thrombotic events like stroke, active symptomatic peripheral vascular disease within last 6 months.
21. Peripheral motor or sensory neuropathy of grade greater than 2.
22. Known hypersensitivity to any components of the study medications / chemotherapy / supportive medications or its ingredients that can impact treatment.
23. Past or current history of neoplasm other than the entry diagnosis with the exception of treated non-melanoma skin cancer or carcinoma in situ of the cervix, or other cancers cured by local therapy alone and patient having a disease-free survival greater than or equal to 5 years.
24. The receipt of an IMP, or participation in a drug research study within a period of 30 days (or as per the respective national regulations) prior to the first dose of the IMP (Elimination half-life of the study drug should be taken into consideration for inclusion of the patient in the study).
25. Any other medical conditions (including mental illness, substance abuse, social situations) deemed by the clinician to be likely to interfere with a subject ability to provide informed consent, cooperate, or participate in the study, or to interfere with the interpretation of the results. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Comparision of efficacy and establishment of therapeutic equivalence of INTP24 (bevacizumab) with Avastin.
 

Every 6 weeks until 18 weeks and thereafter every 9 weeks until 1 year 
 
Secondary Outcome  
Outcome  TimePoints 
Comparision of safety and immunogenicity of INTP24 and Avastin.

Comparision of the pharmacokinetics of INTP24 and Avastin. 
For Safety
Through out the study

For Immunogenicity
screening, at randomization and at 3, 6, 9, 12, 18, 24, 33, 42, 51 and 54 weeks

For Pharmacokinetic
At 3, 6, 9, 12, 18, 24, 33, 42, 51 and 54 weeks 
 
Target Sample Size   Total Sample Size="594"
Sample Size from India="544" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   15/09/2019 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  02/12/2019 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Yet Recruiting 
Recruitment Status of Trial (India)  Other (Terminated) 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  
Lung cancer remains a major cause of morbidity and mortality worldwide, accounting for more deaths than any other cancer cause. Lung cancer has been the most common cancer in the world for several decades. Risk factors for lung cancer are smoking, genetic mutation/predisposition, and occupational/environmental exposure. Biosimilarity of a monoclonal antibody can be established by demonstrating comparable clinical efficacy of the biosimilar and the reference medicinal product in adequately powered, randomised, parallel group comparative clinical trial(s), by using efficacy end points in a study population that is representative of approved therapeutic indication(s) of the reference product and is sensitive for detecting potential differences between the biosimilar and the reference product. To establish the biosimilarity between the test and reference bevacizumab, Intas Pharmaceuticals Limited, India will be conducting this comparative clinical study with the aim of comparing the efficacy and safety of INTP24 (biosimilar bevacizumab) with that of Avastin (Roche Registration Limited, United Kingdom) in patients with advanced, unresectable or metastatic non-squamous non-small cell lung cancer. The study will be a randomized, double-blind, multicentre, multinational, parallelgroup, active-controlled, comparative clinical trial. The study will enrol female or male patients aged greater than or equal to 18 years and having histologically or cytologically-confirmed locally advanced, unresectable or recurrent or metastatic non-squamous non-small cell lung cancer with Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2. Each enrolled patients will be randomized to receive either bevacizumab manufactured by Intas Pharmaceuticals Limited, India or Avastin of Roche Registration Limited, United Kingdom as per randomization schedule generated. All patients will receive intravenous injection of 15 mg/kg of bevacizumab in 21-day cycles. 594 patients will be enrolled.


 
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