CTRI/2026/02/104111 [Registered on: 17/02/2026] Trial Registered Prospectively
Last Modified On:
26/08/2026
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug Biological
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
To Evaluate the Effectiveness, Safety, Pharmacokinetic and Immunogenicity of Intravenous Infusion of Pembrolizumab (Sun Pharmaceutical Industries Limited) in comparison with Reference Medicinal Product (Keytruda) in treatment of Patients with Non-Squamous Metastatic Non-Small Cell Lung Carcinoma
Scientific Title of Study
A Prospective, Multicenter, Randomized, Parallel Group, Double-Blind, Comparative, Active-Controlled, Phase 3 Study to Evaluate the Efficacy, Safety, Pharmacokinetic and Immunogenicity of Intravenous Infusion of Pembrolizumab (Sun Pharmaceutical Industries Limited) in comparison with Reference Medicinal Product (Keytruda) in treatment of Patients with Non-Squamous Metastatic Non-Small Cell Lung Carcinoma
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
ICR/25/012, Version No. 2.0 Dated 14/JAN/2026
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Pravin Ghadge
Designation
AVP and Head – India Clinical Research
Affiliation
Sun Pharma Laboratories Limited
Address
Sun house, Plot No. 201, B/1,
Western Express Highway, Goregaon east. Mumbai (Suburban)
MAHARASHTRA India
Mumbai (Suburban) MAHARASHTRA 400063 India
Phone
9819767704
Fax
02243244324
Email
pravin.ghadge@sunpharma.com
Details of Contact Person Scientific Query
Name
Dr Supriya Sonowal
Designation
Senior Manager 1
Affiliation
Sun Pharma Laboratories Limited
Address
Sun house, Plot No. 201, B/1,
Western Express Highway, Goregaon east. Mumbai (Suburban)
MAHARASHTRA India
Mumbai (Suburban) MAHARASHTRA 400063 India
Phone
9427003728
Fax
Email
Supriya.Sonowal1@sunpharma.com
Details of Contact Person Public Query
Name
Chaitali Bornare
Designation
Senior Manager 2 – Medical Affairs & Clinical Research
Affiliation
Sun Pharma Laboratories Limited
Address
Sun house, Plot No. 201, B/1,
Western Express Highway, Goregaon east. Mumbai (Suburban)
MAHARASHTRA India
Mumbai (Suburban) MAHARASHTRA 400063 India
Phone
7710005651
Fax
Email
Chaitali.Bornare1@sunpharma.com
Source of Monetary or Material Support
Sun Pharmaceutical Industries Limited (SPIL)
Sun House, Plot No. 201 B/1, Western Express Highway,
Goregaon (E), Mumbai 400 063, Maharashtra, India.
Primary Sponsor
Name
Sun Pharmaceutical Industries Limited (SPIL)
Address
Sun House, Plot No. 201 B/1, Western Express Highway,
Goregaon (E), Mumbai 400 063, Maharashtra, India
Type of Sponsor
Pharmaceutical industry-Indian
Details of Secondary Sponsor
Name
Address
Sun Pharmaceutical Industries Limited SPIL
SPARC, Tandalja, Vadodara - 390 012, Gujarat, India
Ground Floor, Department of Oncology,
Aakash Healthcare Super Speciality Hospital, Hospital Plot, Road No. 201, Dwarka Sector-3, Dwarka, Delhi-110075
South West DELHI
9811775324
drpraveen.jain@aakashhealthcare.com
Dr Parida Prasant Kumar
Acharya Harihar Post Graduate Institute of Cancer
Mangalabag, Cuttack, Odisha 753007 Cuttack ORISSA
9583388288
drprasantdm@gmail.com
Dr Sushant Mittal
Action Cancer Hospital
Room No 824, Third Floor Department of Medical Oncology Third Floor A4 Paschim Vihar New Delhi 110063 India. New Delhi DELHI
9818930805 4 Sushantmittal80@gmail.com
Dr Deepam Pushpam
All India institute of medical science
BRA IRCH, Department of Medical Oncology, All India institute of medical science, Ansari Nagar, New Delhi, South Delhi, Delhi, 110029 India South DELHI
9650629370
deepampushpam@gmail.com
Dr Aparna Sharma
All India Institute of Medical Science - National Cancer Institute
Room no 110, First Floor, Department of medical oncology, Badsa, Badli, Jhajjar, Haryana, 124105, India Jhajjar HARYANA
7895683095
Aparna96@gmail.com
Dr Amit Kumar
All India Institute of Medical Sciences
Department of Medical Oncology,Gate No.04,B-Block,Basement,Room No.01,G.E. Road,Tatibandh,Raipur -492099 (C.G.) Raipur CHHATTISGARH
8853858850
amitmedoncoraipur@gmail.com
Dr Amit Sehrawat
All India Institute of Medical Sciences(AIIMS)
Department of Medical Oncology Hematology, Virbhadra Road Rishikesh, Dist-Dehradum-249203. Uttrakhand, India Dehradun UTTARANCHAL
7898167435
amit.monc@aiimsrishikesh.edu.in
Dr Pavithran Keechilat
Amrita Institute of Medical Sciences
AIMS Ponekkara P0,
Kochi - 682041, Kerala, India
Ernakulam KERALA
9895367090
pavithrank@aims.amrita.edu
Dr Shilpa Kandipalli
Andhra Medical College
Department of Medical Oncology, Andhra Medical College, King George Hospital Maharanipeta, Visakhapatnam- 530002, Andhra Pradesh, India Visakhapatnam ANDHRA PRADESH
9440731463
drkshilpamedicaloncology@gmail.com
Dr Ajay Kumar Singh
Apollo Spectra Hospital Apollo Specialty Hospital Pvt. Ltd.
Department of Medical Oncology, Block-1, 1st floor, Basavatarakam Indo American Cancer Hospital RI Road No 10, Banjara Hills, Hyderabad, Telangana- 500034, India Hyderabad TELANGANA
9866154503
mvtkm@yahoo.com
Dr Jasuja Sandeep Kumar
Birla cancer centre- SMS hospital
Department of Medical Oncology & BMT, RK Birla Cancer Center, JLN Marg, SMS Hospital, Jaipur,302004, Rajasthan India Jaipur RAJASTHAN
9660121475
sandeepjasuja@gmail.com
Dr Ishi Sandeep Vithoba
Chopda Medicare and Research Centre Pvt. Ltd
Department of Oncology, Ground Floor OPD, Chopda Medicare and Research Centre Pvt. Ltd Magnum Heart Institute, 3/5, Patil Lane No. 1, Laxmi Nagar, Near K.B.H. Vidyalaya, Canada Corner, Nashik-422005, Maharashtra, India Nashik MAHARASHTRA
8655321807
dr.sandeepishi@gmail.com
Dr Ketan Chandrakanth Shirsath
Darakh Nursing Home & Kidney Stone Centre
1st Floor, Room No. 102, Darakh Nursing Home & Kidney Stone Centre, Raghuveer Nagar, Jalna Road, Chhatrapati Sambhaji Nagar, Maharashtra – 431001 Aurangabad MAHARASHTRA
9028050872
shir60ketan@gmail.com
Dr Deshmukh Chetan Dilip
Deenanath mangeshkar hospital and research Center
Ground floor, Oncology Department, Annex Building, Deenanath mangeshkar hospital and research Center, Erandwane
Pune – 411004.
Pune MAHARASHTRA
9850811449
drchetandeshmukh@rediffmail.com
Dr Chandragouda Dodagoudar
Dr. B.L.Kapur Memorial Hospital
Pusa Road, New Delhi-110005, India New Delhi DELHI
9671004610
doctorsb1kkcr@gmail.com
Dr Amit Pandey
Dr. Ram Manohar Lohia Institute of Medical Sciences
Department of Medical Oncology,
Vibhuti Khand, Gomti Nagar, 226010, Lucknow, Uttar Pradesh, India
Lucknow UTTAR PRADESH
9984657104
vivsonu.pandey@gmail.com
Dr Narayan Adhikari
GBH General Hospital & GBH Memorial Cancer Hospital
Cancer Hospital, Bedwas, Udaipur
GBH General Hospital & GBH Memorial Cancer Hospital
Near Transport Nagar, Airport Road
Bedwas, Udaipur, Rajasthan – 313002, India
Udaipur RAJASTHAN
9654188624
drnarayan.onco@gmail.com
Dr Vandanaben Laljibhai Gohel
Harmony Hospital
301, 401, 402 Puskar Icon, Near Shukan Cross Road, Nikol – Naroda Road, above Croma,
New India Colony, Nikol, Ahmedabad, Gujarat – 382350, India
Ahmadabad GUJARAT
7698702239
vandvgohel@gmail.com
Dr Aman Sondoule
HCG Manavata Cancer Centre
Manavata Health Campus ,Mumbai Naka, Nashik, Maharashtra, 422002, India. Nashik MAHARASHTRA
8087096386
draman@mcrinasik.com
Dr Ankit Batra
Himalayan Institute of Medical Sciences
Himalayan Institute of Medical Sciences
Swami Rama Himalayan University
Swami Rama Nagar, Jolly Grant
Dehradun – 248016, Uttarakhand, India
Dehradun UTTARANCHAL
Indira Gandhi institute of Medical Sciences – state cancer institute
Department of Medical Oncology
Indira Gandhi Institute of Medical Sciences, Indira Gandhi institute of Medical Sciences, Sheikhpura Patna-800014, Bihar, India
Patna BIHAR
9572240838
dralokranjansciigims@gmail.com
Dr Pratap Kishore Das
Indraprastha Apollo Hospital
Sarita Vihar, Delhi Mathura Road, New Delhi-110076 New Delhi DELHI
9810444600
drpratapdas@gmail.com
Dr Subhash Chand Bairwa
Jaipur National University Institute for Medical Sciences and Research Centre
Near New RTO Office, Agra Road, Jagatpura, Jaipur, Rajasthan, 302017 Jaipur RAJASTHAN
Kiran Multi Super Speciality Hospital and Research Center
Basement 2, Clinical Research Department, Near Sumul Dairy, Surat, Gujarat 395004 Surat GUJARAT
9428638448
drpriyalsavaliya@outlook.com
Dr Kannan Jayaraman
Madras Medical College - Rajiv Gandhi Government General Hospital
Department of Oncology, 4th Floor, Room Number: 542, GH Post Office, Poonamallee High Road, 3, Southern Trunk Road, Park Town, Near Chennai Central, Chennai, Tamil Nadu- 600003 Chennai TAMIL NADU
9444143950
Drjkannan.research@gmail.com
Dr Praveen Kumar Shenoy V P
Malabar Cancer Centre, (PGIOSR)
Moozhikkara P O Thalassery, Kannur Kerala, India 670103 Kannur KERALA
Room No 16. /1st floor, Department of Medical Oncology, 98, Old Airport Road, Bangalore, 560017, India Bangalore KARNATAKA
9880463958
amitrauthan@yahoo.com
Dr Amol Shankar Dongre
Max Super Speciality Hospital
(A unit of Alexis Multispeciality Hospital Pvt Ltd) Clinical Research Department, Basement Floor Survey no. 232, House no. 1313, Mankapur Square Koradi Road, Nagpur – 440030 Maharashtra, India Nagpur MAHARASHTRA
9823311569
amolpgi@yahoo.co.in
Dr Ketan Dang
Max Super Speciality Hospital
Mohali (A Unit of Hometrail Buildtech Pvt. Ltd.), Oncology Department, Basement-2
Near Civil Hospital, Phase-6, Mohali, Punjab – 160055, India
Fatehgarh Sahib PUNJAB
9971902111
ketan.dang@maxhealthcare.com
Dr Peush Bajpai
Max Super Speciality Hospital
Dwarka (A Unit of Muthoot Hospitals Pvt. Ltd.), Room No. C5, 1st Floor,
Plot No. 1, Sector 10, Dwarka, New Delhi – 110075.
New Delhi DELHI
8527207978
peush.bajpai@maxhealthcare.com
Dr Swarnabindu Banerjee
Medical College & Hospital
Kolkata, 88, College Street, Kolkata, West Bengal, 700073 Kolkata WEST BENGAL
9830955686
dr.swarnabindubanerjee@gmail.com
Dr Vyas Vinay
Medipulse Hospital
E4, MIA, Basni II Phase, Opposite AIIMS Link Rd, Jodhpur, Rajasthan 342005 Jodhpur RAJASTHAN
9413063148
vinay25vyas@gmail.com
Dr Krishna Kumar Rathnam
Meenakshi Mission Hospital and Research Centre
Lake area, Melur road, Madurai. Tamil Nadu-625107 Madurai TAMIL NADU
9380417299
kkrathnam@grnail.com
Dr Ranade Anantbhushan Anil
MMFHA, Joshi Hospital
778, Shivaji Nagar, Opposite Kamala Nehru Park, Pune,411004
Maharashtra, India
Pune MAHARASHTRA
9890716263
drranadeaa@gmail.com
Dr Dhamne Nilesh Ashok
MOC Cancer Care & Research Centre
517/A/1, Plot no 04, ‘E’ ward, Station Road, Tararani Chowk, Shivaji Park, beside Hotel International, Kolhapur, Maharashtra 416002 Kolhapur MAHARASHTRA
7738245698
dr.nilesh.gmc@gmail.com
Dr Murtaza Bohra
National Cancer Institute
CRS Department, 1st floor National Cancer Institute Khasara No 25, Outer Hingna Ring Road, Mouza, Jamtha, Nagpur- 441108, Maharashtra India Nagpur MAHARASHTRA
9687657952
Murtubohra52@gmail.com
Dr GUNDETI SADASHIVUDU
Nizams Institute of Medical Sciences
Room no 26, Out Patient Block, Ground floor Department of Medical Oncology, Nizams Institute of Medical Sciences, Panjagutta, Hyderabad 500082 Telanagana Hyderabad TELANGANA
9440911865
drssgundeti@yahoo.com
Dr Bellala Ravi Shankar
Omega Hospital
Omega Hospital, Chinnagadhili, Health City, Arilova, Visakhapatnam 530040, Andhra Pradesh, India Visakhapatnam ANDHRA PRADESH
9849123256
drbravishankarresearch@gmail.com
Dr Amit Badola
Oncocare Cancer & Super Speciality Hospital
Near Joya Toll Plaza, NH-24, Amroha, Uttar Pradesh – 244222, India Jyotiba Phule Nagar UTTAR PRADESH
9758449955
dramitbadola58@gmail.com
Dr Manoj U Mahajan
Pacific Medical College & Hospital
Bhillo Ka Bedla, NH 27, Pratapura,
Udaipur, Rajasthan – 313001
1st Floor, 8th Block, Department of Oncology Udaipur RAJASTHAN
9829645117
clinical.research.pmch@gmail.com
Dr Pawan kumar singh
PDIMS Sharma Postgraduate institute of medical Sciences
PDIMS Sharma Postgraduate institute of medical Sciences, Near Delhi Bye Pass, rohtak-124001, Haryana. India. Rohtak HARYANA
01262281307
director.pgims@uhsr.ac.in
Dr Abhinav Dewan
Rajiv Gandhi Cancer Institute and Research Centre
Sir Chotu Ram Marg,
Rohini Institutional Area, Sector 5, Rohini Delhi -110085
North West DELHI
8860100008
drabhinavdewan@gmail.com
Dr Surender Kumar Beniwal
S. P. Medical College and AG of Hospitals,
Department of Medical Oncology, Ground Floor, RCC,S. P. Medical College and AG of Hospitals,Bikaner, 334003, Rajasthan Bikaner RAJASTHAN
9414370484
Beniwal.surendra@gmail.com
Dr Aniket Thoke
Sanjeevani CBCC USA Cancer Hospital
In front of Jain Mandir, Dawada Colony, Pachpedi Naka, Raipur, Chhattisgarh 492001, India Raipur CHHATTISGARH
9752292974
drthoke@gmail.com
Dr Venkata Pradeep Babu Koyyala
Shankara Cancer and Research Institute
3rd Floor, Dorika Hospital,
Near RO Motors, Tezpur,
Assam, India – 784154
Sonitpur ASSAM
8297761776
pradeepbabu.koyyala@gmail.com
Dr Panasara Keyur Hasmukhbhai
Shankus Hospitals
Bunker Area, Room No.– 05, B/h Divine Child School, Near Shankus Water Park,
Ahmedabad–Mehsana Highway,
Baliyasana, Mehsana, Gujarat – 382732, India
Mahesana GUJARAT
9725497992
kpanasara@gmail.com
Dr Nishant Sinha
Shri Guru Ram Rai Institute of Medical & Health Sciences & Shri Mahant Indiresh Hospital
Patel Nagar, Dehradun, Uttarakhand – 248001, India Dehradun UTTARANCHAL
#35, H. Siddaiah Road, Wilson Garden, Bengaluru 560027, Karnataka, India. Bangalore KARNATAKA
8971609070
drlokeshsrv@gmail.com
Dr Abhinav Narvariya
Subharti Medical College & Hospital
Department of Oncology, Subharti Medical College & Hospital, Subhartipuram, NH-58, Delhi-Haridwar Bypass Road, Meerut-
250005. UP. India
Meerut UTTAR PRADESH
9755577441
abhinavnarwariya842@gmail.com
Dr Puranik Reshma Nitin
Sushrut Hospital
4612/12, Paud Road, Mahaganesh Colony,Kothrud, Pune – 411038, Maharashtra Pune MAHARASHTRA
02035320000
admin@sushruthospitalpune.com
Dr Ramkumar Bakthavachalam
Tamil Nadu Government Multi Super Specialty Hospital
Department of Medical Oncology, 1st Floor, Omandurar Government Estate, Anna Salai,
Chennai – 600002, India
Chennai TAMIL NADU
9444018665
drramkumarb.research@gmail.com
Dr Kumar Prabhash
Tata Memorial Centre
OPD No 204, 2nd Floor, Homi Bhabha Block, Tata Memorial Centre, Dr. Ernest Borges Road, Parel, Mumbai - 400012 Mumbai MAHARASHTRA
9167760576
Kprabhash1@gmail.com
Dr Akash Dineshbhai Patel
Trisha Multispeciality Hospital
1,5,6,7 Floor, Dream Square, Nirnaynagar Under Bridge, Nr Nava Vadaj Bus Stop, Nirnaynagar, Ahmedabad 380013 Ahmadabad GUJARAT
8826001414
adpatel5887@gmail.com
Dr Wategaonkar Ravikumar Narayan
Vedant Multispeciality Hospital
ground floor, GP 83, Opp Rotary Club. Sambhaji Nagar, MIDC. Chinchwad, Pune-411019 Pune MAHARASHTRA
9823602626
rnwategaonkar@gmail.com
Dr Kaushal Karla
VMMC & Safdarjung Hospital
Old SIC building hematology and medical oncology block, VMMC & Safdarjung Hospital, New Delhi 110029 India New Delhi DELHI
Ethics Committee S.M.S. Medical College and Attached Hospitals
Submittted/Under Review
ETHICS COMMITTEE, S.P. MEDICAL COLLEGE
Approved
IEC King George hospital
Submittted/Under Review
IEC-MMC and RI and Associated Hospital
Submittted/Under Review
IEC-Vedant Multispeciality Hospital
Submittted/Under Review
Institute Ethics Committee All India Institute of Medical Sciences
Submittted/Under Review
Institute Ethics Committee, AIIMS, Raipur
Submittted/Under Review
Institute Ethics Committee, All India Institute of Medical Sciences
Submittted/Under Review
Institute Ethics Committee, All India Institute of Medical Sciences
Submittted/Under Review
Institutional Ethics Committee
Submittted/Under Review
Institutional Ethics committee
Submittted/Under Review
Institutional Ethics Committee
Submittted/Under Review
Institutional Ethics Committee
Submittted/Under Review
INSTITUTIONAL ETHICS COMMITTEE
Submittted/Under Review
Institutional Ethics Committee
Submittted/Under Review
Institutional Ethics Committee for Human Research
Submittted/Under Review
Institutional Ethics Committee I.
Submittted/Under Review
Institutional Ethics Committee Max Healthcare Ethics Committee
Approved
Institutional Ethics Committee Max Super Speciality Hospital Nagpur A Unit of Alexis Multispeciality Hospital Pvt Ltd
Approved
Institutional Ethics Committee VMMC and SJH
Submittted/Under Review
Institutional Ethics Committee, IGIMS
Submittted/Under Review
Institutional Ethics Committee, Max Super Speciality Hospital
Approved
Institutional Ethics Committee, Omega Hospital
Approved
Institutional Ethics Committee, Sparsh Hospital
Submittted/Under Review
Institutional Ethics Committee-Malabar Cancer Centre
Submittted/Under Review
Institutional Review Board
Submittted/Under Review
Instutional Ethics Committee-Clinical Studies
Submittted/Under Review
Kiran Hospital Ethics Committee
Approved
Madras Medical College
Submittted/Under Review
Mahalaxmi Health Care Pvt Ltd
Approved
Manavata Clinical Research Institute Ethics Committee
Approved
Mangala Institutional Ethics Committee
Submittted/Under Review
Medipulse Hospital Institutional Ethics Committee
Approved
National cancer Institute Ethics Committee
Submittted/Under Review
NIMS Institutional Ethics Committee
Submittted/Under Review
Ranchi Urology Centre Institutional Ethics Committee
Submittted/Under Review
Sangini Hospital Ethics Committee
Approved
Sanjeevani Cancer Hospital Ethics Committee
Submittted/Under Review
Subharti Medical College and Hospital
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
Comparator Agent
Keytruda® (Pembrolizumab) injection (100mg/4mL) of Merck Sharp & Dohme (MSD)/Merck& Co
Keytruda® (Pembrolizumab) injection 200 mg every 3 weeks as intravenous infusion till EOT along with pemetrexed and platinum therapy
Intervention
Pembrolizumab Injection (100mg/4mL) of Sun Pharmaceutical Industries Limited (SPIL)
Pembrolizumab Injection 200
mg every 3 weeks as intravenous infusion till EOT along with pemetrexed and platinum therapy
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
1) Male or female, aged 18 to 65 years (both inclusive) at the time of signing informed consent
2) Histologically or cytologically confirmed diagnosis of Non-Squamous type of metastatic (stage IV) NSCLC
3) Patients expressing PD-L1 with no EGFR or ALK genomic tumour aberration
4) Has measurable disease at screening based on RECIST 1.1
5) 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.]
6) Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status at screening and randomization.
7) Life expectancy of at least 6 months.
8) Patients with following laboratory parameters at screening
• Absolute neutrophil count (ANC) more than equal to 2.0 X 109/L
• WBC more than equal to 3.5 X 109/L
• Hemoglobin more than equal to 9.0 g/dL
• Platelets more than equal to 100 X 109/L
• AST and ALT levels less than equal to 2.5 X ULN (less than equal to 5 X ULN, in case of liver metastases)
• Serum total bilirubin less than equal to 1.5 x ULN
• calculated creatinine clearance (CrCl) more than equal to 60 mL/min (calculated using the Cockcroft-Gault Method)
• International Normalized Ratio (INR) or Prothrombin Time (PT) less than equal to 1.5 X ULN unless the subject is receiving anticoagulant Therapy
•Activated Partial Thromboplastin Time (aPTT) or Partial Thromboplastin Time (PTT) less than equal to 1.5 X ULN unless the subject is receiving anticoagulant therapy
• TSH or FT3 and FT4 are within normal limit
9) Women of childbearing potential must have a negative urine pregnancy test at Screening and Randomization and agree to use highly effective methods of contraception to prevent pregnancy throughout the study and for at least 4 months after end of treatment with Pembrolizumab (such contraception may include hormonal birth control e.g. combined estrogen and progestogen containing [oral, intravaginal, or transdermal] or progesterone only [oral, injectable, or implantable] hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone releasing system OR bilateral tubal occlusion, vasectomized partner, or total sexual abstinence OR non-hormonal contraception [e.g. condoms with spermicide]). [Note: Women with childbearing potential are defined as: those who are not (1) surgically sterile (bilateral oophorectomy, hysterectomy, or bilateral tubal ligation) or (2) post-menopausal. Postmenopausal woman will be defined as: Woman not using hormonal replacement therapy and have had at least 12 continuous months of natural (spontaneous) amenorrhea and be greater than 45 years of age]
10) Male Patients and their female partners of childbearing potential should agree to use contraceptive measures throughout the study and for at least 4 months after end of treatment with Pembrolizumab. (Note: Acceptable methods of contraception: A. Male: Vasectomy, Condoms, Total abstinence; B. Females: hormonal birth control e.g., combined estrogen and progestogen containing [oral, intravaginal, or transdermal] or progesterone only [oral, injectable, or implantable], intrauterine devices, intrauterine hormone releasing system, bilateral tubal occlusion, or total sexual abstinence)
ExclusionCriteria
Details
1) Patient with history of hypersensitivity reactions to any of the study drugs including background chemotherapy or its excipients or platinum containing components or immune related reactions to monoclonal antibodies
2) Patients with predominantly squamous cell histology NSCLC.
[Mixed tumors will be categorized by the predominant cell type; if small cell elements are present, then subject is ineligible
3) Patients who have received prior antineoplastic biological therapy (e.g., erlotinib, crizotinib, cetuximab)
4) Patients who have received radiation therapy to the lung that is more than 30 Gy within 6 months prior to randomization.
5) Patients completing palliative radiotherapy within 7 days prior to randomization
6) Has received a live-virus vaccination prior to 30 days of randomization. Seasonal flu vaccines that do not contain live virus are permitted.
7) Has clinically active diverticulitis, intra-abdominal abscess, GI obstruction, abdominal carcinomatosis.
8) Has a known history of prior malignancy except if the subject has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy. (criteria applicable for malignancy other than NSCLC)
9) Patient with active CNS metastases and/or carcinomatous meningitis
10) Patients on chronic steroid use. Patients with asthma that require intermittent use of bronchodilators, inhaled steroids, or local steroid injections would not be excluded from the study.
11) Is unable or unwilling to take folic acid or vitamin B12 supplementation.
12) Has an active infection requiring therapy
13) Patients with positive result of human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) at screening visit.
14) Has a history or current evidence of any medical condition, psychiatric condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject’s participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating Investigator or Sponsors medical monitor.
15) Known or suspected abuse of alcohol or recreational drugs
16) Patient with symptomatic ascites or pleural effusion. [A patient who is clinically stable following treatment for these conditions (including therapeutic thoraco - or paracentesis) is eligible.]
17) Is pregnant or breastfeeding, or expecting to conceive or father children during the study.
18) Patients with a history of Interstitial Lung Disease
19) Participation in any clinical study of an investigational product within the previous 3 months
20) Employee of the Sponsor or Investigator or study centre with direct involvement in the proposed study or other studies under the direction of that Investigator or study centre, as well as family members of the employees of Sponsor or the Investigator.
Method of Generating Random Sequence
Stratified randomization
Method of Concealment
Centralized
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
Proportion of patients with progression free survival
at week 24 and week 36 and 52
Secondary Outcome
Outcome
TimePoints
Objective Response Rate
up to week 24 and week 36 and week 52
Overall survival rate
at week 24 and week 52
Best overall response
at week 24 and week 52
Duration of progression free survival
at week 24 and week 52
changes in health-related quality-of-life assessments from baseline to each visit
Pharmacokinetic
up to cycle 6
Incidence of TEAE
at week 24 and week 52
Proportion of patients with ADA and Nab
at baseline and week 24 and week 52
Target Sample Size
Total Sample Size="237" Sample Size from India="237" 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)
23/02/2026
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="0" 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
This is a randomized, multi-centric, double-blind, active-controlled, parallel, comparative, phase III study.The study will be conducted in approximately up to 20 centres from various parts of India, having qualified Investigators. The study will be initiated only afterthe receipt of regulatory and ethics committee (EC) approval.
The total duration of the screening period will be of maximum 2 weeks (14 days).