CTRI

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CTRI Number

CTRI/2025/07/090716 [Registered on: 11/07/2025] Trial Registered Prospectively

Last Modified On:

22/04/2026

Post Graduate Thesis

No

Type of Trial

Interventional

Type of Study

Biological

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

Effectiveness and safety study of Inj. Pembrolizumab in patients with Lung cancer

Scientific Title of Study

A Prospective, Randomized, Double Blind, Multiple Dose, Multicenter, Active Controlled, Comparative, Parallel Study to Evaluate the Efficacy, Safety, Pharmacokinetic and Immunogenicity of Intravenous Infusion of Hetero-Pembrolizumab (Hetero Biopharma Ltd, India) and Reference Medicinal Product (Pembrolizumab, Merck Sharp & Dohme B.V) in Patients with Non- Squamous Type of Metastatic Non-Small Cell Lung Carcinoma (mNSCLC).

Trial Acronym

Nil

Secondary IDs if Any

Secondary ID	Identifier
HCR/III/PEMBNSCLC/06/2024; version 1.0, Date: 16-Aug-2024	Protocol Number

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

Name	Dr Shubhadeep Sinha
Designation	Senior Vice President and Head
Affiliation	Hetero Biopharma Limited
Address	7-2-A2, Hetero Corporate, Industrial Estates, Sanath Nagar Hyderabad Hyderabad TELANGANA 500018 India
Phone	04023704923
Fax
Email	sd.sinha@hetero.com

Details of Contact Person
Scientific Query

Name	Dr Sreenivasa Chary S
Designation	Senior General Manager
Affiliation	Hetero Biopharma Limited
Address	7-2-A2, Hetero Corporate, Industrial Estates, Sanath Nagar Hyderabad Hyderabad TELANGANA 500018 India
Phone	04023704923
Fax
Email	sreenivasa.chary@hetero.com

Details of Contact Person
Public Query

Name	Dr Shubhadeep Sinha
Designation	Senior Vice President and Head
Affiliation	Hetero Biopharma Limited
Address	7-2-A2, Hetero Corporate, Industrial Estates, Sanath Nagar Hyderabad Hyderabad TELANGANA 500018 India
Phone	04023704923
Fax
Email	sd.sinha@hetero.com

Source of Monetary or Material Support

Hetero Biopharma Limited 7-2-A2, Hetero Corporate, Industrial Estates, Sanath Nagar Hyderabad

Primary Sponsor

Name	Hetero Biopharma Limited
Address	7-2-A2, Hetero Corporate, Industrial Estates, Sanath Nagar Hyderabad
Type of Sponsor	Pharmaceutical industry-Global

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study
Modification(s)

No of Sites = 28
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Vamshi Krishna M	AIG Hospitals	Oncology Department, Basement 3, Tower A, Room No.6, Survey No 136, Plot No 2/3/4/5, Mindspace Road, Gachibowli, 500032, INDIA Hyderabad TELANGANA	9959778112 drmvkrishnaonco@gmail.com
Dr A Ravi Sankar	Aster Narayanadri Hospital	Department of Medical Oncology, Room No. 1, Basement floor Chittoor ANDHRA PRADESH	8919880170 arigela.ravisankar@gmail.com
Dr MVT Krishna Mohan	Basavatarakam Indo-American Cancer Hospital and Research Institute	Room No:367, 3rd Floor Road No-10 Banjara hills, 500034, India. Hyderabad TELANGANA	9866154503 mvtkm@yahoo.com
Dr Tanmoy Kumar Mandal	Binayak Multispeciality Hospital	Oncology Department, Clinical Trial Room, 1st Floor, Room No.1 Kolkata WEST BENGAL	9073361042 tanmoy.m@gmail.com
Dr Chandrani Khatri	Charak Hospital and Research Centre	Department of Medical Oncology, Room No:1, 1st Floor, Dubagga, 226003, India Lucknow UTTAR PRADESH	9971328328 drchandranikhatri@gmail.com
Dr Kalyan Kusum Mukherjee	Chittaranjan National Cancer Institute	Room No: 3, 3rd Floor, Clinical Research Room, 37 S.P. Mukherjee Road, 700026, ndia Kolkata WEST BENGAL	9830115905 Kkmukherjee4u@hotmail.com
Dr Shuchita Pathak	Dayanand Medical College & Hospita	Department of Medical Oncology, Room No. 6, Cancer Centre Basement, Ludhiana PUNJAB	9680119691 shuchi1104@gmail.com
Dr Sachin Sharadchandra Hingmire	Deenanath Mangeshkar Hospital	1st floor, Oncology Research Department, LMMFS, Erandawane, Pune 411004 Pune MAHARASHTRA	9324517648 sshingmare@yahoo.com
Dr Sachin Khurana	Dr. BR Ambedkar Institute Rotary Cancer Hospital, All India Institute of Medical Sciences	1st floor, Room No. 160A, Ansari Nagar, 110029, India New Delhi DELHI	9769030180 dr.sachinkhurana@gmail.com
Dr Kavi Sankar Venkatachalam	Erode Cancer Centre	Department of Medical Oncology, Ground Floor, Room No: 33 Erode TAMIL NADU	9944585824 eccmedonco@gmail.com
Dr K Lakshmi Priyadarshini	HCG City Cancer Centre	Department of Medical Oncology, Room No. 01, Ground Floor, HCG City Cancer Centre, 33-25-33, Ch Venkata Krishnayya Street, Suryaraopet, 520002, India. Krishna ANDHRA PRADESH	9966030988 priyadarshini006@gmail.com
Dr Alok Ranjan	Indira Gandhi Insitute of Medical Sciences	Department of Medical Oncology, Room No.225, 2nd floor, State Cancer Institute, 800014, India Patna BIHAR	9572240838 dralokranjansciigims@gmail.com
Dr Tushar Patil Vishvasrao	Integrated Cancer Treatment & Research Centre	Department of Medical Oncology, Room No: OPD 3, Ground Floor Pune MAHARASHTRA	9552522556 tussipats@hotmail.com
Dr Rajani Priya Yedla	Mahatma Gandhi Cancer Hospital & Research Institute	Department of Medical Oncology, Room No. 13, Ground floor Visakhapatnam ANDHRA PRADESH	9640953911 drrajinipriya@gmail.com
Dr Srinivasa Tejaswini Adada	Mallareddy Narayana Multispeciality Hospital	Department of Medical Oncology, Oncology OPD Room No: 02, Ground Floor Hyderabad TELANGANA	9676629345 drtejaswini8588@gmail.com
Dr Satya Pal Kataria	Medanta-The Medicity	Department of Medical Oncology, Room No. 19, 10th Floor Gurgaon HARYANA	9868818541 spkataria@yahoo.com
Dr P Radhika	MNJ Institute of Oncology & Regional Cancer Centre	Department of Medical Oncology, Ground Floor Red Hills, 500004, India Hyderabad TELANGANA	9848792682 radhika.parimkayala@gmail.com
Dr Vikas L	Mysore Medical College & Research Institute	Medical Oncology Department, Room No.1, 1st Floor Mysore KARNATAKA	9663099774 vikilaxman@gmail.com
Dr Rachan Shetty K S	Omega Hospitals (P) Ltd	Department of Medical Oncology, Oncology OPD Room No: B11, Floor Basement Dakshina Kannada KARNATAKA	9008753317 drrachanshetty.medoncology@gmail.com,
Dr Kannan Jayaraman	Rajiv Gandhi General Government Hospital.	Department of Medical Oncology, Tower 1,4th Floor, Madras, Park Town, Chennai Central, 600003, India Chennai TAMIL NADU	9444143950 drjkannan.research@gmail.com
Dr Vikas T Talreja	Regency Hospital Ltd.	Department of Medical Oncology, Room No: 2, 1st floor Kanpur Nagar UTTAR PRADESH	9769890961 vikastalreja@gmail.com
Dr Arun Kumar Lingutla	Sai Sindhu Foundation-Sindhu Hospitals,	Oncology Department Room no:132, Second Floor, Cluster - 3, Sy.no: 41/14/2, Khanamet(V), Serilingampalli(M), Ranga Reddy, 500084, India Hyderabad TELANGANA	7382348479 drarunkl@yahoo.co.in
Dr Anita Ramesh	Saveetha Medical College and Hospital	Department of Medical Oncology, 6th floor, Room No.4, Saveetha Nagar, Thandalam, 602 105, India Chennai TAMIL NADU	9840758567 anitachandra100@hotmail.com
Dr Amol Shankar Dongre	Siddharth Gupta Memorial Cancer Hospital	Department of Medical Oncology, Ground Floor, Room No.3, Sawangi, Meghe,442107, India Wardha MAHARASHTRA	93229 78781 amolpgi@yahoo.co.in
Dr Ghanashyam Biswas	Sparsh Hospital	Department of Radiotherapy, A/407, Shaheed Nagar, Bhubaneswar, 751007, India. Cuttack ORISSA	9937500878 drgbiswas@gmail.com
Dr Prem Kumar Devdoss	Tamil Nadu Government Multi Super Speciality Hospital	Room No. 1014, 1st floor, Omandurar Estate, 600002, India Chennai TAMIL NADU	9043964072 drpremkumar.tngmssh@gmail.com
Dr Ankit Patel	Unique Hospital	Opp. Kiran Motors, nr. Canal, Civil char rasta, sosyo circle lane, off. Ring road, 395002, India. Surat GUJARAT	9825404202 drankitoncologist@gmail.com
Dr Kaushal Kalra	Vardhman Mahavir Medical College and Safdarjung hospital	Room No.701, 7th floor old SIC, Medical oncology Block, 110029, India. New Delhi DELHI	9968663394 kaushalkalra@yahoo.com

Details of Ethics Committee
Modification(s)

No of Ethics Committees= 28
Name of Committee	Approval Status
Saveetha Medical College & Hospital Institutional Ethics Committee,	Approved
"Institutional Ethics Committee Sparsh Hospitals and Critical Care Private Limited"	Approved
"Medanta Institutional Ethics Committee Medanta-The Medicity"	Approved
Drug Trial Ethics Committee, Dayanand Medical College and Hospital	Approved
Ethics Committee Mysore Medical College and Associated hospital	Approved
Ethics committee, Unique Hospital	Approved
Insitutional Ethics Committee, Aster Narayandri Hospital	Approved
Institutional Ethics Committee VMMC and Safdarjung Hospital	Submittted/Under Review
Institutional Ethics committee Deenanath Mangeshkar Hospital And Research Centre	Submittted/Under Review
Institutional Ethics Committee Erode Cancer Centre Private Limited	Approved
Institutional Ethics Committee HCG Curie City Cancer Centre	Approved
Institutional Ethics Committee MNJ Institute of Oncology and Regional Cancer	Approved
Institutional Ethics Committee of DMIHER Datta Meghe Institute Of Higher Education And Research	Approved
Institutional Ethics Committee, Charak Hospital and Research Centre	Approved
Institutional Ethics Committee, Chittaranjan National Cancer Institute	Submittted/Under Review
Institutional Ethics Committee, IGIMS	Approved
Institutional Ethics committee, All India Institute of Medical Sciences	Approved
Institutional Ethics Committee, Basavatarakam Indo-American Cancer Hospital and Research Institute	Submittted/Under Review
Institutional Ethics Committee, Binayak Multispeciality Hospital	Approved
Institutional Ethics Committee, Madras Medical College	Approved
Institutional Ethics Committee, Malla Reddy Medical College for Women	Approved
Institutional Ethics Committee, Sai Sindhu Foundation-Sindhu Hospitals	Approved
Institutional Ethics Committee, TNGMSSH Tamil Nadu Govt. Multi Super Specialty Hospital	Submittted/Under Review
Institutional Ethics Committee- Asian Institute of Gastroenterology	Approved
Institutional Review Board, Mahatma Gnadhi Cancer Hospital & Research Institute	Approved
Omega Ethical Committee, Omega Hospital	Approved
Regency Hospital Ethics Committee, Regency Hospital	Approved
Supreme Independent Ethics Committee, Ingenious Health Care	Approved

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	Hetero-Pembrolizumab (Hetero Biopharma Ltd, India)	200 mg of Pembrolizumab will be administered as intravenous infusion over 30 minutes every 3 weeks
Comparator Agent	RMP Pembrolizumab (Merck Sharp & Dohme B.V)	200 mg of Pembrolizumab will be administered as intravenous infusion over 30 minutes every 3 weeks

Inclusion Criteria

Age From	18.00 Year(s)
Age To	65.00 Year(s)
Gender	Both
Details	1. Male or female patients of 18 - 65 years of age. 2. Histologically or cytologically confirmed diagnosis of Non Squamous type of metastatic NSCLC. 3. Tumor with PD-L1 positive (Expression greater than or equal to 50 percent) determined by immunohistochemistry and without any EGFR, ALK positive mutations. 4. Have not received prior systemic treatment for their advanced/metastatic NSCLC. [Patients who received adjuvant or neoadjuvant therapy are eligible if the adjuvant/neoadjuvant therapy was completed at least 12 months prior to the development of metastatic disease.] 5. Patients with Eastern Cooperative Oncology Group (ECOG) Score 0 – 1. 6. Patients with screening laboratory tests within the following criteria: a. Haemoglobin greater than or equal to 9.0 g/dL b. WBC greater than or equal to 3.5 X 109/L c. Neutrophils greater than or equal to 2.0 X 109/L d. Platelets greater than or equal to 100 X 109/L e. Serum transaminase levels greater than or equal to 2.5 X ULN (less than or equal to 5 X ULN, in case of liver metastases) f. Serum Bilirubin less than or equal to 1.5 x ULN in the absence of liver metastases g. Serum creatinine levels less than or equal to 1.5 mg/dL h. Calculated creatinine clearance greater than or equal to 60 mL/min (Cockcroft-Gault formula) i. PT/ aPTT /INR less than or equal to 1.5 X ULN unless the patient is receiving anticoagulant therapy j. Thyroid Stimulating Hormone (TSH) – Within normal limits

ExclusionCriteria

Details

1. Predominantly squamous cell histology NSCLC. [Mixed tumors will be categorized by the predominant cell type; if small cell elements are present, the patient is ineligible]
2. Patient with symptomatic ascites or pleural effusion.
3. Patient is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose less than or equal to 1.3 g per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam).
4. Patients with interstitial lung disease or prior pneumonitis required systemic corticosteroid therapy.
5. Received radiation therapy to the lung that is greater than or equal to 30 Gy within 6 months of the first dose of trial treatment.
6. Has received a live-virus vaccination within 30 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted.
7. Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti- CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (any antibody or drug specifically targeting Tcell co-stimulation or checkpoint pathways).
8. Patient with renal impairment (creatine clearance less than or equal to 60 mL/min) or receiving dialysis.
9. Patients undergone major surgery within 3 weeks prior to fist dose.
10. Patient with a known history of prior malignancy except if the patient has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy.
11. Participation in any clinical study of an investigational product within the previous 3 months.

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Centralized

Blinding/Masking

Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

Primary Outcome

Outcome	TimePoints
Objective response rate (ORR) at the end of cycle 8 (Week 24)	Screening and end of Cycle 8 (Week 24)

Secondary Outcome

Outcome	TimePoints
Objective Response Rate (ORR) at end of Cycle 4 (Week 12), Cycle 12 (Week 36) and Cycle 17 (Week 52)	Baseline, at end of Cycle 4 (Week 12), Cycle 12 (Week 36) and Cycle 17 (Week 52)
Progression-free Survival (PFS) at the end of Cycle 8 (Week 24), Cycle 12 (Week 36) and Cycle 17 (Week 52)	Baseline at the end of Cycle 8 (Week 24), Cycle 12 (Week 36) and Cycle 17 (Week 52)
Overall Survival (OS) at the end of Cycle 17 (Week 52)	Baseline end of Cycle 17 (Week 52)
Pharmacokinetic parameters o Primary – AUC0-tau. ss at Cycle 6 o Secondary – Cmax & Ctrough.ss at Cycle 1 & 6, as applicable	AUC0-tau. ss at Cycle 6 Cmax and Ctrough.ss at Cycle 1 & 6
Comparative incidence and titers of anti-Pembrolizumab antibodies at Baseline, end of Cycle 4 (Week 12), Cycle 8 (week 24), Cycle 12 (Week 36) and Cycle 17 (Week 52)	Baseline, end of Cycle 4 (Week 12), Cycle 8 (week 24), Cycle 12 (Week 36) and Cycle 17 (Week 52)
Comparative treatment emergent adverse events by monitoring significant clinical signs and symptoms and laboratory abnormalities till end of Cycle 17 (Week 52)	Baseline and end of Cycle 17 (Week 52)

Target Sample Size

Total Sample Size="228"
Sample Size from India="228"
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)

21/07/2025

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="3"
Months="0"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Open to Recruitment

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

This study is a double blind, randomized, active controlled, parallel group clinical study to evaluate the efficacy, safety, pharmacokinetics and Immunogenicity of Intravenous Infusion of Hetero – Pembrolizumab and Reference-Pembrolizumab in Patients with Non-Squamous Type of Metastatic Non-Small Cell Lung Carcinoma (NSCLC). The study will consist of up to 21-days screening period, 24 weeks of treatment period followed by primary analysis. Approximately 228 patients will be enrolled in Hetero-Pembrolizumab or Reference-Pembrolizumab. Patients with histologically or cytologically confirmed with Non-Squamous type of metastatic NSCLC with PD-L1 positive (Expression greater than or equal to 50 percentage) determined by immunohistochemistry, without any EGFR, ALK positive mutations, measurable disease based on RECIST 1.1, not received prior systemic treatment for their advanced/metastatic NSCLC and ECOG score of 0-1 will be enrolled in this study. All patients will be administered either Hetero-Pembrolizumab or Reference-Pembrolizumab for 17 cycles along with standard chemotherapeutic regimen of Carboplatin and Pemetrexed.