CTRI/2025/01/079282 [Registered on: 23/01/2025] Trial Registered Prospectively
Last Modified On:
17/08/2026
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Biological
Study Design
Randomized, Parallel Group, Multiple Arm Trial
Public Title of Study
A Study to Compare Efficacy, Safety, and Immunogenicity of GME751 and EU-authorized Keytruda in Adult Participants with Untreated Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC)
Scientific Title of Study
A randomized, double-blind, parallel-group study to compare efficacy, safety, and immunogenicity of GME751 (proposed pembrolizumab biosimilar) and EU-authorized Keytruda(R) in adult participants with untreated metastatic non-squamous non-small cell lung cancer (NSCLC)
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
2023-506882-70-00
EudraCT
CGME751A12301, Version 1.0, dated: 24-Jul-2023
Protocol Number
NCT06159790
ClinicalTrials.gov
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Parexel International Clinical Research Private Limited
CoWrks, RMZ EcoWorld, Ground Floor, Bay Area Adjacent to Building 6A, Outer Ring Road, Devarabeesanahalli Village, BENGALURU 560103, Karnataka, INDIA
Countries of Recruitment
Bosnia and Herzegovina Brazil Georgia Germany India Japan Malaysia Philippines Romania Serbia Spain Taiwan Thailand Turkey United States of America Viet Nam
Sites of Study
No of Sites = 22
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Shailesh Bondarde
Apex Wellness Hospital
Survey No. 799, Plot No. 187, behind Prakash Petrol Pump, Govind Nagar, Nasik 422009, Maharashtra, India Nashik MAHARASHTRA
2532470999
Shaileshbondarde@yahoo.com
Dr Vijay Agarwal
Apollo Hospitals
154/11, Opp. IIM, Bannerghatta road, Bangalore, Karnataka-560076, India. Bangalore KARNATAKA
08026304050
drvijay-agarwal@apollohospitals.com
Dr Manak Gujrani
Department of Pulmonary Medicine, S. P. Medical College and AG of Hospitals
Bikaner, Rajasthan-334003, India Bikaner RAJASTHAN
01512226300
drmanakgujrani@gmail.com
Dr Chandragouda Dodagoudar
Dr B L Kapur Memorial Hospital
Pusa Road, New Delhi-110005, India New Delhi DELHI
01130403040
drchandru1976@yahoo.co.in
Dr Raj Nagarkar
HCG Manavata Cancer Centre
Behind Shivang Auto, Mumbai Naka, Nashik, Maharashtra-422002, India Nashik MAHARASHTRA
2536661111
drraj@manavatacancercentre.com
Dr Satheesh C T
Healthcare Global Enterprises Limited
8, P Kalinga Rao Road, HCG Towers, Sampangi Ram Nagar, Bengaluru, Karnataka-560027, India Bangalore KARNATAKA
8040206000
drsatheeshct@gmail.com
Dr Sandip Abhaykumar Shah
Hemato Oncology Clinic Ahmedabad Pvt. Ltd.
Ground floor and First floor, Near Samved Hospital, Stadium Commerce College Road, Navrangpura, Ahmedabad, Gujarat-380009, India Ahmadabad GUJARAT
7940042223
SANDIP60@GMAIL.COM
Dr Maheshkumar Kalloli
KLES Dr Prabhakar Kore Hospital and Medical Research Centre
Nehru Nagar, Belagavi, Karnataka-590010, India Belgaum KARNATAKA
08312473777
mahesh.kalloli@gmail.com
Dr Chetan Dilip Deshmukh
LMMFs Deenanath Mangeshkar Hospital and Research center
Erandawane, Pune, Maharashtra-411004, India Pune MAHARASHTRA
02040151000
drchetandeshmukh@gmail.com
Dr Akhil Kapoor
Mahamana Pandit Madan Mohan Malaviya Cancer Centre
Department of Medical Oncology, Sundar Bagiya, Near Nariya Gate, Banaras Hindu University Campus, Varanasi, Uttar Pradesh-221005 India Varanasi UTTAR PRADESH
05422225022
kapoorakhil1987@gmail.com
Dr Balaji Keshavrao Shewalkar
Marathwada Regional Cancer Center and Research Institute,
G.M.C.H. Near Jama masjid, Front of aam khas maidan, Aurangabad, Maharashtra-431001, India. Aurangabad MAHARASHTRA
9850632639
drbalajishewalkar482@gmail.com
Dr Sandeep Batra
Max Super Speciality Hospital, Saket (A Unit of Devki Devi Foundation)
2, Press Enclave Road, Saket, New Delhi -110017, India New Delhi DELHI
9811035061
sandeepriya2000@yahoo.com
Dr Anand Bhaskarrao Pathak
National Cancer Institute
Khasar No.25, outer Hingna Ring Road, Mouza, Jamtha, Nagpur, Maharashtra-441108, India Nagpur MAHARASHTRA
18002330033
abpathak21@gmail.com
Dr Sadashivudu Gundeti
Nizams Institute of Medical Sciences,
Department of Medical Oncology
Panjagutta, Hyderabad, Telangana-500082, India
Hyderabad TELANGANA
4023489360
drssgundeti@yahoo.com
Dr Minish Jain
Noble Hospital Pvt Ltd
Ground Floor, OPD-Room No. 18, 153 Magarpatta City Road, Hadapsar Pune-411013, Maharashtra, India Pune MAHARASHTRA
Amravati Ethics Committee, Sujan Surgical Cancer Hospital and Amravati Cancer Foundation, 52/B Shankar Nagar, Main Road, Amravati, Maharashtra-444605, India
Submittted/Under Review
ApexEthicsCommittee
Approved
Dr. B. L. Kapur Memorial Hospital Ethics Committee Dr. B.L.Kapur Memorial Hospital, Pusa Road, New Delhi-110005, India
Approved
Ethics Committee of CIMS, Care Institute of Medical Science, Opp. Panchamrut Bunglows, Nr. Shukan Mall, off Science City Road, Sola, Ahmedabad, Gujarat-380060, India
Approved
Ethics Committee Sir Ganga Ram Hospital Room No-1643, 6th floor, old building, Sir Ganga Ram Hospital, Rajinder Nagar, New Delhi-110060, India.
Submittted/Under Review
Ethics Committee, S. P. Medical College and AG of Hospitals, Pawanpuri, Bikaner, Rajasthan-334003, India
Submittted/Under Review
GCRI/GCP Ethics Committee The Gujarat Cancer & Research Institute M.P. Shah Cancer Hospital, Civil Hospital Campus, Asarwa, Ahmedabad 380016 Gujarat India
Approved
HCG Central Ethics Committee N0.8, P Kalinga Rao Road, HCG Towers, Sampangi Ram Nagar, Bengaluru, Karnataka-560027, India
Approved
IEC I & II: Institutional Ethics Committee, Clinical Research Secretariat, 3rd Floor, Main Building, Tata Memorial Hospital, Dr. Ernest Borges Road, Parel, Mumbai – 400012, Maharashtra, India
Approved
Institutional Ethics Committee (IEC), Devki Devi Foundation Service Floor, Office of Ethics Committee, East block, Next to Conference Room, Max Super Speciality Hospital, Saket (A Unit of Devki Devi Foundation) 2, Press Enclave Road, Saket, New Delhi – 110017, India
Submittted/Under Review
Institutional Ethics committee, (IMC-GMCA), Department of Pharmacology, Government medical college, Aurangabad, Maharashtra-431001, India.
Submittted/Under Review
Institutional Ethics Committee, Deenanath Mangeshkar Hospital & Research Centre, off Karve Road, Erandawane, Pune, Maharashtra-411004, India
Submittted/Under Review
Institutional Ethics Committee, Indira Gandhi Institute of Medical Sciences, Sheikhpura Raja Bazar, Patna Bihar-800014, India
Submittted/Under Review
Institutional Ethics Committee, KLE Academy of Higher Education and Research (KAHER), JNMC Campus, Nehru Nagar, Belagavi, Karnataka-590010, India.
Approved
Institutional Ethics Committee, MPMMCC & HBCH, Varanasi, Mahamana Pandit Madan Mohan Malaviya Cancer Centre, Sundar Bagiya, Near Nariya Gate, Banaras Hindu University Campus, Varanasi, Uttar Pradesh-221005. India
Approved
Institutional Ethics Committee, PD Hinduja Hospital and Medical Research Centre, Veer Savarkar Marg, Mahim, Mumbai, Maharashtra-400016, India.
Approved
Institutional Ethics Committee, Sparsh Hospital, & Critical Care (P) Ltd, A/407, Saheed nagar, Bhubaneswar, Odisha-751007, India
Approved
Institutional Ethics Committee- Clinical Studies, Apollo Hospitals, 154/11, Opp. IIM, Bannerghatta road, Bangalore, Karnataka-560076, India.
Approved
Manavata Clinical Research Institute Ethics Committee, HCG Manavata Cancer Centre, Behind Shivang Auto, Mumbai Naka, Nashik, Maharashtra-422002, India
Approved
National Cancer Institute Ethics Committee Khasar No.25, outer Hingna Ring Road, Mouza, Jamtha, Nagpur, Maharashtra-441108, India
Approved
NIMS-Institutional Ethics Committee 2nd floor, SRC, NIMS old block, Panjagutta, Hyderabad, Telangana-500082, India
Approved
Noble Hospital Institutional Ethics committee, Noble Hospital Pvt. Ltd Room no. 5, Clinical Research Department, Noble Annex, 153 Magarpatta city road, Hadapsar, Pune-411013, Maharashtra, India.
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
Intervention
GME751
GME751 Concentrate for solution for infusion, Biologic, Liquid in vial, 100 mg, 200 mg every 3 weeks, i.v. infusion Drug: Pemetrexed (i.v. infusion) Drug: Carboplatin or Cisplatin (i.v. infusion)
Comparator Agent
Keytruda-EU
Keytruda-EU Concentrate for solution for infusion, biologic, liquid in vial, 100 mg, 200 mg every 3 weeks, i.v. infusion Drug: Pemetrexed (i.v. infusion) Drug: Carboplatin or Cisplatin (i.v. infusion)
Inclusion Criteria
Age From
18.00 Year(s)
Age To
95.00 Year(s)
Gender
Both
Details
1. At least 18 years of age
2. Untreated metastatic NSCLC
3. Absence of tumor activating EGFR mutations and absence of ALK gene rearrangements
4. Measurable disease according to RECIST 1.1
5. Adequate organ function
6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
ExclusionCriteria
Details
1. Squamous cell or mixed histology in NSCLC
2. Known history of hypersensitivity (grade 3) to pembrolizumab, chemotherapy or their excipients
3. Active autoimmune disease that has required chronic systemic treatment in the past 2 years.
4. Received live vaccine more than 30 days before the first study treatment
5. Prior treatment with pembrolizumab or any other anti-PD-1, or anti-PD-L1 or anti-PD-L2, or anti-CTLA-4 agent or any antibody targeting other immune-regulatory receptors or mechanisms for lung cancer.
Method of Generating Random Sequence
Other
Method of Concealment
Other
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
To demonstrate efficacy equivalence (BOR as per RECIST 1.1) between GME751 and Keytruda-EU in participants with untreated metastatic non-squamous NSCLC (irrespective of PD-L1 status and with no EGFR or ALK mutations) with background platinum-based chemotherapy.
The primary endpoint is the BOR of either CR or PR according to RECIST 1.1 up to 9 months.
Secondary Outcome
Outcome
TimePoints
Progression free survival - similarity between GME751 & Keytruda-EU
52 weeks
Overall survival - similarity between GME751 & Keytruda-EU
52 weeks
Duration of response in terms of Progression free survival - similarity between GME751 & Keytruda-EU
52 weeks
Safety in terms of TEAEs & SAEs - evaluate & compare between GME751 & Keytruda-EU
52 weeks
Pembrolizumab serum concentrations - To evaluate & compare between GME751 & Keytruda-EU.
Compare descriptively Ctrough of GME751 & Keytruda-EU at Week 1, 2, 4, 16 to 49 & 52 weeks
Immunogenicity - evaluate & compare between GME751 & Keytruda-EU
Development of binding & neutralizing ADAs up to 52 weeks.
Target Sample Size
Total Sample Size="720" Sample Size from India="91" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
The purpose of this study is to
investigate the efficacy, safety, and immunogenicity
of GME751 compared with Keytruda® (pembrolizumab) in participants
with untreated metastatic non-squamous NSCLC (irrespective of PD-L1 status),
without sensitizing EGFR or ALK mutations.
Eligible
participants will be randomized in a 1:1 ratio to receive either GME751, or
European Union (EU)-authorized pembrolizumab (Keytruda-EU) in combination with
chemotherapy. The maximum study duration for a participant will be
approximately 56 weeks including screening.
Treatment duration
is 52 weeks (17 treatment cycles of study treatment GME751 or Keytruda-EU in
combination with chemotherapy, each cycle with a duration of 3 weeks).
Participants will
discontinue study participation in case of disease progression, unacceptable
toxicity or other reasons.
Participants who are
benefiting from treatment with pembrolizumab without signs of progression or
unacceptable toxicity will be eligible for continued pembrolizumab treatment
via most suitable option based on the respective country regulations.