CTRI

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CTRI Number

CTRI/2025/03/083471 [Registered on: 26/03/2025] Trial Registered Prospectively

Last Modified On:

07/07/2025

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Drug

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

Study to evaluate efficacy, safety, immunogenicity and pharmacokinetics of Lupin Nivolumab (LUBT022) with Innovator Nivolumab of Patients with locally advanced or metastatic non-small cell lung cancer

Scientific Title of Study

A randomized, double-blind, multi-center, active-control, parallel group study to compare efficacy, safety, immunogenicity and pharmacokinetics of Lupin Nivolumab (LUBT022) with Innovator Nivolumab in patients with locally advanced or metastatic non-small cell lung cancer

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
LRP/ LUBT022/2024/002 version 1.1dated9 Dec 2024	Protocol Number

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Chirag Shah
Designation	Vice President
Affiliation	Lupin Ltd
Address	1st floor A Wing Green Building NDDD CRU Survey No 46A 47A Village Nande Tal Mulshi Pune MAHARASHTRA 412115 India
Phone	02066749068
Fax
Email	chiragshah@lupin.com

Details of Contact Person
Scientific Query

Name	Dr Chirag Shah
Designation	Vice President
Affiliation	Lupin Ltd
Address	1st floor A Wing Green Building NDDD CRU Survey No 46A 47A Village Nande Tal Mulshi Pune MAHARASHTRA 412115 India
Phone	02066749068
Fax
Email	chiragshah@lupin.com

Details of Contact Person
Public Query

Name	Dr Neelam Kardekar
Designation	Assistant Director
Affiliation	Lupin Ltd
Address	1st floor A Wing Green Building NDDD CRU Survey No 46A 47A Village Nande Tal Mulshi Pune MAHARASHTRA 412115 India
Phone	02066747372
Fax
Email	neelamkardekar@lupin.com

Source of Monetary or Material Support

Lupin Limited, Lupin Research Park,46A/47A, Village Nande, Taluka Mulshi, Pune 412115, Maharashtra, India

Primary Sponsor

Name	Lupin Limited
Address	Gate No: 1156, Village-Ghotawade, Taluka-Mulshi, Pune. Pin: 412115 Maharashtra, India
Type of Sponsor	Pharmaceutical industry-Indian

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study
Modification(s)

No of Sites = 59
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Dipti Rani Samantha	Acharya Harihar Postgraduate Institute of Cancer	PI chamber 4th floor Medical Oncology department room no 024 ground floor Cuttack Odisha India 753003 Cuttack ORISSA	9437032728 diptiranisamanta@rediffmail.com
Dr Sandip Barik	AIIMS Bhubaneshwar	Ground Floor Dept of Radiation OPD Cubicle 1 Sijua Patrapada Bhubaneshwar Odisha India 751019 Cuttack ORISSA	9450381454 sandip.barik1@gmail.com
Dr Ishu Gupta	Amerix Cancer Hospital	society of Unique Hospital and reserach institute sector 19, opp. welcome hotel Dwarka 110075 New Delhi New Delhi DELHI	9899258492 ishuguptamd@gmail.com
Dr K Pavithran	Amrita Institute of Medical Sciences	First floor A block Tower 1 AIMS Ponekkara PO Kochi 682041 Kerala Ernakulam KERALA	9895367090 pavithrank@aims.amrita.edu
Dr Prabagar Manickam	Ashwin Multispeciality Hospital	Sathy Road, 1, Alamu Nagar rd, Near GP Theatre, Gandhipuram, TamilNadu 641012 India Coimbatore TAMIL NADU	9443681554 drprabagar.acr@gmail.com
Dr Magesh Padmanabha Kamath	BGS Global Institute of Medical Sciences	Department of Medical Oncology BGS Global Institute of Medical Sciences No 67, BGS Health & Education City Uttarahalli Road Kengeri Bangalore 560060 Karnataka India Bangalore KARNATAKA	9900587736 mangeshk.research@gmail.com
Dr Tanmoy Mondal	Binayak Multi Speciality Hospital	Binayak Enclave 59 Kalicharan Ghosh Road West Bengal Kolkata 700050. Kolkata WEST BENGAL	9051238499 tanmoy.nrs@gmail.com
Dr Kuntal Ray	Charnock Hospital	Ground floor BMC 195 Biswa Bangla Sarani Teghoria Newtown Kolkata– 700157 India Kolkata WEST BENGAL	9775281345 kuntal.1911@gmail.com
Dr Kalyan Kusum Mukherjee	Chittaranjan National Cancer Institute	Room no. 303 3rd floor Research building Chittranjan National Cancer Institute 37 SP Mukherjee Road Kolkata West Bengal 700026 India Kolkata WEST BENGAL	9830115905 kkmukherjee4u@hotmail.com
Dr Akash Tiwari	DNS Hospital Pvt. Ltd	Basement 14 Anoop Nagar LIG Square AB Road Indore MP-452008 Indore MADHYA PRADESH	9968721696 akash07tiwari@gmail.com
Dr Sanjay Rai	ESIC Medical College & Hospital	4th floor DAV College Road Near Saheed Bhagat Singh College New Industrial Township Faridabad Haryana 121001 India Faridabad HARYANA	8766316202 drrai_s@yahoo.com
Dr Rajat Bajaj	Fortis Hospital Noida	B-22, Sector 62, Noida- 201301, Uttar Pradesh, INDIA Gautam Buddha Nagar UTTAR PRADESH	9953183797 rajatb.mamc@gmail.com
Dr Shantanu Pendse	HCG Cancer Center	Ground floor Mouja Wanjri Khasra No 50 51 Ring Road Near Automotive Square Kalam Bande Nawaz Nagar Binaki Nagpur 440017 Maharashtra India Nagpur MAHARASHTRA	8600863057 drshantanu.s@hcgel.com
Dr Sanketh Kotne	HCG Cancer Centre	OPD-2 Ground floor plot no 10 survey no 13P APIIC Health City Arilova Chinnagadili Vishakhapatnam Andhrapradesh 530040 Visakhapatnam ANDHRA PRADESH	7013222831 drsanketh.k@hcgel.com
Dr K Lakshmi Priyadarshini	HCG City Cancer Centre	Ground floor 33 25 33 CH Venkata krishnayya street Surya Rao Pet Vijayawada 520002 Andhra Pradesh India Krishna ANDHRA PRADESH	996030988 priyadarshini006@gmail.com
Dr Mukesh Chaudhari	HCG Manavata Cancer Center	Department of Medical Oncology first floor behind shivang auto Mumbai Naka-422004 Maharashtra India Nashik MAHARASHTRA	9096920416 drmukesh@mcrinasik.com
Dr Chirag Desai	Hemato Oncology Clinic Ahmedabad Pvt. Ltd.	Nirmaya Complex” Ground Floor to Third Floor, Beside Pandit Dindayal Upadhyay Auditorium, Rajpath Club Road, Off S G Highway,Ahmedabad-380054, Gujarat. Ahmadabad GUJARAT	7600598812 chiragdesai.oncology@gmail.com
Dr Alok Ranjan	Indira Gandhi Institute of Medical Science	1st floor Room No112 Sheikhpura Patna 800014 Bihar India Patna BIHAR	8521861068 dralokranjansciigims@gmail.com
Dr Vijay Bhargava	Jawaharlal Nehru Cancer Hospital and Research Centre	Idgah Hills PB No 32 Bhopal Madhya Pradesh 462001 India Bhopal MADHYA PRADESH	9512965930 drvijayoncologist@gmail.com
Dr Ameya Koranne	Kailash Cancer Hospital and Research Centre	Department of Medical Oncology Kailash Cancer Hospital and Research Centre Muni Seva Ashram Goraj Waghodia Vadodara 391760 Gujrat India Vadodara GUJARAT	7874361520 ameya.koranne@gaeenash ram.org
Dr Keshav Garg	Kainos Super Speciality Hospital	Kheri Sadh Bypass, Delhi road Rohatak, 124001, Haryana India Rohtak HARYANA	9729179012 garg488keshav@gmail.com
Dr Saurabh Prasad	KIMS-Kingsway Hospitals	Room number 501 5th floor KIMS Kingsway Hospitals Medisearch Lifesciences Pvt Ltd 44 Parwana Bhavan, Kingsway Road Kasturchand Park Nagpur440001 Maharashtra India Nagpur MAHARASHTRA	7066580511 drsaurabhprasad@gmail.com
Dr Priyanka Das	Kiran Multi Super Speciality Hospital and Research Center	Cluster-G OPD room no2 1st floor Near Sumul Dairy Surat 395004 Gujarat India Surat GUJARAT	9987239416 drpriyankagdas@gmail.com
Dr Rohan Bhise	KLEs Dr. Prabhakar Kore Hospital and Medical Research Centre	Cancer building Ground floor OPD number C3 NH Service Road Nehru Nagar Belagavi Karnataka 590010 India Belgaum KARNATAKA	9448866712 rohanbhise30@gmail.com
Dr Ashwin Rajbhoj	Life Point Multispecialty Hospital	No. 145, Sr, 1, Mumbai Pune Bypass Rd, Near Sayaji Hotel, Wakad, Pune, Maharashtra 411057 Pune MAHARASHTRA	8793398680 rajbhojashwin11@gmail.com
Dr Poulami Basu	Lifeline Diagnostic Centre Cum Nursing Home	Department of oncology 4A Wood Street Kolkata- 700016 West Bengal India Kolkata WEST BENGAL	6290073778 poulamibasu18386@gmail.com
Dr Anuj Gupta	Mahamana Pandit Madan Mohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital	OPD 33 Ground floor D and T Block Madan Mohan Malaviya Cancer Centre MPMMM and Homi Bhabha Cancer Hospital (HBCH), Sundar Bagiya Near Nariya Gate BHU Campus Varanasi 221005 Uttar Pradesh India Varanasi UTTAR PRADESH	9588229594 dr.anuj.gupta24@gmail.com
DrRajanipriya Yedla	Mahatma Gandhi Cancer Centre	Vizag Plot No1 Sector7 MVP Colony Visakhapatnam Andhra Pradesh 530017 Visakhapatnam ANDHRA PRADESH	9640953911 drrajinipriya@gmail.com
Dr Lalit Mohan Sharma	Mahatma Gandhi Medical College and Hospital	4th floor Clinical research room Sri Ram Cancer Centre SRCC annex building Sri Ram Cancer and Superspeciality Centre, Mahatma Gandhi Medical College and Hospital RIICO Institutional Area Tonk Road Sitapura Jaipur 302022 Jaipur RAJASTHAN	9928602244 drlalit2003@gmail.com
Dr Saju S V	Meenakshi Mission Hospital & Research Centre	1st floor main building Lake Area Melur Road Madurai Tamil Nadu 625107 Madurai TAMIL NADU	7904423513 drsajusr@gmail.com
Dr Ketan Shirsath	MGM Medical College and Hospital	Gate No 2 MGM Campus n 6 CIDCO Chhatrapati Sambhajinagar Aurangabad Maharashtra 431003 Basement room no.22 Aurangabad MAHARASHTRA	9028050872 drketan.mgmmcha@gmail.com
Dr P Radhika	MNJ Institute of Oncology and Regional Cancer Center	Department of medical oncology AC Gaurds roads Hydrabad 500004 Telangana India Hyderabad TELANGANA	9848792682 radhika.parimkayala@gmail.com
Dr Kshitij Joshi	MOC, Cancer Care& Research centre	Ville parle, Mumbai, Maharashtra, 400057 Mumbai MAHARASHTRA	9833662891 drkshitijjoshi@mocindia.co.in
Dr Abhishek Anand	Narayana cancer center	Rd no. 0, Indrapuri, Keshri, Nagar, Patana, Bihar 800024 Patna BIHAR	8105502481 drabhishek2508@gmail.com
Dr Meher Lakshmi Konatam	Nizam’s Institute of Medical Science	Ground floor RoomNo25 Punjgutta Hyderabad 500082 Telangana India Hyderabad TELANGANA	9440592569 drmeherlak@gmail.com
DrRushabh Kothari	Oncowin Cancer Center	Room no OPD 2 7th Floor HR Elanza Vikas Gruh Road Nr Mahalaxmi Five Roads Paldi Ahmedabad-380007 Ahmadabad GUJARAT	9167196692 rushabhkothari13@yahoo.com
Dr Anshul Agarwal	PP Maniya Hospital Private LTD	OPD-5 1st floor Mamta Park Society-1 opp Dharuka College Kapodra Varachha Main Road Surat Gujarat- 395006 INDIA Surat GUJARAT	8657068668 anshul.oncology@gmail.com
Dr Sandeep Jasuja	R K Birla Cancer Center SMS Medical College	Jaipur 302004 Rajasthan India Jaipur RAJASTHAN	9660121475 sandeepjasuja99@gmail.com
Dr Lokesh K N	Radhakrishna Multispeciality Hospital And IVF Center	OPD no 6or 7 Ground Floor Radhakrishna Multispecialty Hospital & IVF Center 3-4 Sunrise Towers, 1st phase Girinagar Banashankari 3rd Stage Bengaluru Karnataka 560085 Bangalore KARNATAKA	8971609070 drlokeshkn.rmh@gmail.com
Dr Kannan Jayaraman	Rajiv Gandhi Government General Hospital Madras Medical College	6th floor Tower 3 G H Post office Poonumalle High Road 3 Grand southern Tank Road Park Town Chennai 600 003. Chennai TAMIL NADU	8921219255 drjkannan.research@gmail.com
Dr Aditi Harsh Thanky	Rajkot Cancer Society	5th floor Nathalal Parekh Cancer Institute Near Hanuman Madhi Chowk 1 Tirupati Nagar Rajkot 360007 Gujarat India Rajkot GUJARAT	9925025381 aditik2008@yahoo.com
Dr Aniket Thoke	Sanjeevani CBCC USA Cancer Hospital	Unit I ground floor Department of Medical Oncology Sanjeevani CBCC USA Cancer Hospital Infront Jain Mandir Dawada Colony Pachpedi Naka Raipur 492001 India Raipur CHHATTISGARH	9752929741 drthoke@gmail.com
Dr Bhushan Tapiram Nemade	Sankalp Specialty Hospital	OPD room no 1 Ground floor Dhanvantari Marg Vallabh Nagar Behind Chhan Hotel Mumbai Agra Highway Mumbai Naka Nashik Maharashtra India- 422009 Nashik MAHARASHTRA	9766126162 drvknemade@yahoo.co.in
Dr Surender Beniwal	Sarder Patel Medical College and Hospital	Sardar Patel Colony Bikaner Rajasthan 334001 India Bikaner RAJASTHAN	9414370484 beniwal.surendra@gmail.com
Dr Kausadikar Shripad Rameshrao	Seth Nandlal Dhoot Hospital	Ground floor A1 A2 MIDC Chikalthana Jalna road Near Airport Aurangabad Maharashtra India 431210 Aurangabad MAHARASHTRA	9909928993 drsrkausadikar.research@gmail.com
Dr Viraj Lavangia	Shalby Hospital	9th Floor Clinical research department Opp Karnvati Club SG Highway Ahmedabad-380015 Gujarat India Ahmadabad GUJARAT	9908711057 drvirajlavingia@gmail.com
Dr Alpesh Kikani	Shashwat Haemato Onco Assocaites	2nd Floor CIGIS Hospital NrBalaji Hall 150 Feet Ring Road Rajkot 360004 Gujarat India Rajkot GUJARAT	9601649096 alpesh.kikani@shashwat.one
Dr Satheesh C T	Spandana Oncology Centre	Room no 1 consultant ground floor 919 New No 68 28th Main Road 9th block Jayanagar Bangalore-560068 Bangalore KARNATAKA	9242698750 drsatheeshct@gmail.com
Dr Ghanshayam Biswas	Sparsh Hospital & Critical care Pvt. Ltd	Ground floor old building A/407 Saheed Nagar Khordha Bhubaneshwar Odisha-751007 India Khordha ORISSA	9937500878 drgbiswas@gmail.com
Dr Karthikeyan S	SRM Medical College Hospital and Research Center	SRM Nagar, Kattankulathur 603203, Chengalpattu district, TamilNadu, India. Chennai TAMIL NADU	9964839602 drkarthikssmc@gmail.com
Dr Sathiyamoorthy PN	Stanley Hospital and Medical College	Unnamed Road, seven wells north, old washermanpet, chennai Chennai TAMIL NADU	9444221535 drpnsathiyamoorthy.research@gmail.com
Dr Javvid Muzamil	Super speciality govt medical college	Department of oncology Ground floor Karan nagar Srinagar Jammu and Kashmir 190010 Srinagar JAMMU & KASHMIR	7006787372 javvidmd@gmail.com
Dr Neha Gupta	Swami Harshankaranand Ji Hospital and Research Centre	Room no 9 Ground floor N 8 237 Newada BHU DLW Road Sunderpur Varnasi 221004 Uttar Pradesh India Varanasi UTTAR PRADESH	8004354185 drneha_500@yahoo.com
Dr Premkumar Devadoss	Tamil Nadu Government Multi Super Speciality Hospital	1st floor Depart of Clinical Research Omandurar Government Estate Opp the Hindu Mount Road Anna Salai Chennai Tamil Nadu 600002 Chennai TAMIL NADU	8792567193 drpremkumar.tngmssh@gmail.com
Dr Rakesh Taran	Taran Onco Care	Ground floor 1 Ravindra Nagar Near Patrakar Square Indore MP 452018 Indore MADHYA PRADESH	9009779517 rakeshtaran@yahoo.com
Dr Vanita Noronha	Tata Memorial Hospital	OPD 303 Homi Babha Building Dr Ernest Borges Rd Parel East Parel Mumbai Maharashtra 400012 India Mumbai MAHARASHTRA	9769328047 vanita.noronha@gmail.com
Dr Ankit Patel	Unique Hospital Multispeciality and Research Insititute	Ground floor OPD 1and 2 OPP Kiran Motors Nr Canal Civil Hospital Char Rasta Sosyo circle lane Off Ring Road Surat 395002 Surat GUJARAT	9825404202 dr.ankitoncologist@gmail.com
Dr Kaushal Kalra	VMMC and safdarjung Hospital	New delhi-110029 New Delhi DELHI	9968663394 kaushalkalra@yahoo.com
Dr Harish Kancharla	Yashoda Super Specialty Hospital	Raj Bhavan Road Somajiguda Hydrabad 500082 Telangana India Hyderabad TELANGANA	9781812244 harik486@gmail.com

Details of Ethics Committee
Modification(s)

No of Ethics Committees= 59
Name of Committee	Approval Status
Aurangabad healthcare and research LLP IEC	Submittted/Under Review
Charnock Ethics Committee Charnock Hospital Pvt. Ltd.	Approved
Ethics comittee for research on human subjects	Submittted/Under Review
Ethics Comittee SMS Medical College and attached hospital	Submittted/Under Review
Ethics Committee , S.P. Medical College	Submittted/Under Review
Ethics Committee, Sanjeevani Cancer Hospital	Submittted/Under Review
Ethics Committee, Unique Hospital	Submittted/Under Review
Fortis Hospital Institutional Ethics Committee	Submittted/Under Review
Good Society For Ethical Research	Submittted/Under Review
HCG NCHRI cancer center Institutional ethics Committee	Submittted/Under Review
Human Ethics Committee, Regional Cancer Center	Submittted/Under Review
IEC Lifeline diagnostic center cum nursing homr	Submittted/Under Review
Independent EC Namaste Integrated Services	Submittted/Under Review
Institutional Ethics Comittee Acharya Harihar post graduate institute of cancer	Submittted/Under Review
Institutional Ethics Comittee BGS	Approved
Institutional Ethics Comittee for ESIC Faridabad	Submittted/Under Review
Institutional ethics comittee KLE University	Submittted/Under Review
Institutional Ethics Comittee MPMMCC	Submittted/Under Review
Institutional Ethics Comittee-II TMC	Submittted/Under Review
Institutional Ethics Committee Ethics Committee - Shalby Limited	Submittted/Under Review
Institutional Ethics Committee IGIMS	Submittted/Under Review
Institutional Ethics Committee Amrita Institute of Medical Sciences AIMS	Submittted/Under Review
Institutional Ethics Committee BGS Institute	Approved
Institutional Ethics Committee Chittaranjan National Cancer Institute	Submittted/Under Review
Institutional Ethics Committee Government Stanley Medical College and Hospital	Submittted/Under Review
Institutional Ethics Committee HCG Cancer Centre	Submittted/Under Review
Institutional Ethics Committee Human, Gokul Lifecare Private Limited	Submittted/Under Review
Institutional Ethics Committee Human, Gokul Life Care Pvt Ltd.	Submittted/Under Review
Institutional Ethics Committee Kainos Super Speciality Hospital	Submittted/Under Review
Institutional Ethics Committee Manavata Clinical Research	Submittted/Under Review
Institutional Ethics Committee Spandana Oncology Centre	Approved
Institutional Ethics Committee Sparsh Hospital and Critical Care Private limited	Submittted/Under Review
Institutional Ethics Committee VMMC And SAFDARJUNG HOSPITAL	Submittted/Under Review
Institutional Ethics Committee, Madras Medical College, Rajiv Gandhi Government Hospital	Submittted/Under Review
Institutional Ethics Committee, AIIMS	Submittted/Under Review
Institutional Ethics Committee, Ashwin Hospital Ashwin Hospital	Submittted/Under Review
Institutional Ethics Committee, BSL Eye Care	Submittted/Under Review
Institutional Ethics Committee, itcucurie city, cancer center	Submittted/Under Review
Institutional Ethics Committee, KCHRC, Muni Seva Ashram	Submittted/Under Review
Institutional Ethics Committee, Mahatama Gandhi Medical College and Hospital	Submittted/Under Review
Institutional Ethics Committee, Meenakshi Mission Hospital and Research Centre	Submittted/Under Review
Institutional Ethics Committee-TNGMSSH	Submittted/Under Review
Institutional Ethics CommitteeSuper speciality govt medical college Karan nagar Srinagar	Submittted/Under Review
Institutional Review Board Mahatama Gandhi Cancer Hospital,Research Institute	Submittted/Under Review
Instiutional Ethics Committee,GKMC	Submittted/Under Review
Kingsway Hospital Ethics Committee	Submittted/Under Review
Kiran Hospital Ethics Committee (Kiran Hospital Multi Super Speciality Hospital and Research Center	Submittted/Under Review
Lifepoint Research- Ethics Committee	Submittted/Under Review
MNJ Institute of Oncology & Regional Cancer Center, Ethics Committee	Submittted/Under Review
Mumbai Oncocare Centre IEC Cellcure-Cancer Centre Private Limited	Submittted/Under Review
Navsanjeevani Hospital Ethics Committee	Approved
NIMS Institutional Ethics Committee	Submittted/Under Review
PP Maniya Hospital Ethics Committee PP Maniya Hospital Pvt Ltd	Submittted/Under Review
Rectitude Ethics commitee, DNS Hospital	Submittted/Under Review
Rectitude Ethics commitee, DNS Hospital Pvt. Ltd	Submittted/Under Review
Sangani Hospital Ethics Committee	Submittted/Under Review
SRM Medical College Hospital and Research Centre	Submittted/Under Review
Swarnim Ethics Committee	Submittted/Under Review
Yashoda Academy of Medical Education and Research	Submittted/Under Review

Regulatory Clearance Status from DCGI

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	Innovators Nivolumab (Opdivo®/Opdyta®)	dose is 3 mg/kg every 14 days 30 - minute intravenous infusion for upto 12 cycles
Intervention	Lupin Nivolumab (LUBT022)	dose is 3 mg/kg every 14 days 30 - minute intravenous infusion for upto 12 cycles

Inclusion Criteria

Age From	18.00 Year(s)
Age To	99.00 Year(s)
Gender	Both
Details	Male or female 18 years of age Patient with histologically or cytologically confirmed diagnosis Patients must have experienced disease recurrence or progression after one first line therapy Patients must have received at least 2 cycles of chemotherapy Patients who received adjuvant neoadjuvant or definitive chemoradiation therapy within 6 months Patients with recurrent disease greater than 6 months Presence of at least one measurable target lesion as per RECIST criteria version 1.1 ECOG performance status of 0 or 1 8 Screening laboratory values that meet the ANC Platelets Hemoglobin Serum bilirubin AST and ALT Serum creatinine creatinine clearance criteria as per protocol

ExclusionCriteria

Details

Patients with CNS metastases are eligible only if the metastases are adequately treated Patient with a condition requiring systemic treatment with either corticosteroids Patient with active known or suspected autoimmune disease All toxicities attributed to prior anti-cancer therapy Prior therapy with anti-tumor vaccines or other immuno-stimulatory antitumor agents Prior radiotherapy or radiosurgery received within 2 weeks prior to screening Patients with interstitial lung disease Prior therapy History of other primary malignancy Positive test result for HIV Hepatitis B Hepatitis C History of allergy or intolerance History of hypersensitivity reactions Major surgical procedure or significant traumatic injury within 28 days prior to screening Received any therapy Pregnant or lactating women & all men who not follow contraceptive measure

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

On-site computer system

Blinding/Masking

Participant, Investigator and Outcome Assessor Blinded

Primary Outcome

Outcome	TimePoints
Overall Response Rate (ORR)	Overall Response Rate (ORR) at Baseline, Cycle 5, Cycle 9, EOS,

Secondary Outcome

Outcome

TimePoints

Efficacy:
• Disease control rate (DCR)
Safety:
• Incidence of TEAEs
Immunogenicity:
• Proportion of patients with binding and
neutralizing antibodies at the end of Cycle 4, 8,
and 12
Pharmacokinetics:
• Descriptive assessment of PK parameters in subgroup

Efficacy:
• Disease control rate (DCR) at the end of Cycle 12
Safety:
• Incidence of TEAEs baseline to End of study till cycle 12
Immunogenicity:
• immunogenicity will be collected pre-dose at Cycle 1, at the end of Cycle 4 (pre-dose of Cycle 5), Cycle 8 (pre-dose of Cycle 9),
and at end of Cycle 12 (pre-dose of EOS)
• Descriptive assessment of PK parameters in subgroup at C1D1,C1D2,C1D3,C1D7, C4D1, C6D1, C8D1, C10D1,
C12D1 and at EOS

Target Sample Size

Total Sample Size="202"
Sample Size from India="202"
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)

07/04/2025

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="1"
Months="6"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

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

Response - NO

Brief Summary

The proposed study is a randomized, double blind, parallel arm clinical trial to compare the efficacy, safety, immunogenicity and pharmacokinetics in patients with previously treated locally advanced or metastatic non-small cell lung cancer (NSCLC) following exposure cycle 12 (24 weeks). This is a monotherapy. The trial will include a screening period (upto 4 weeks), and a double-blind treatment period. The eligible patient will be randomized and receive test or reference arm. Patient will be dosed on 3 mg/kg solution by intravenous (IV) route every 2 weeks till cycle 12 (week 24-last dose) or until disease progression or discontinued from the study due to any other reasons. Overall response rate will be assessed (radiological assessment) as per RECIST 1.1 criteria. PK parameters will be evaluated as Cmax, AUC, terminal phase half-life.