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CTRI Number  CTRI/2026/03/106344 [Registered on: 16/03/2026] Trial Registered Prospectively
Last Modified On: 16/03/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Clinical study of QL2107 versus Keytruda® in participants with lung cancer 
Scientific Title of Study   A Randomized, Double Blind, Multicenter, Pharmacokinetic Equivalence Clinical Trial of QL2107 (Keytruda® Biosimilar Candidate) in Comparison with Keytruda® (Pembrolizumab) for Adjuvant Therapy to Demonstrate Pharmacokinetic Similarity in Subjects with Resected Non Small Cell Lung Cancer 
Trial Acronym  Qilu PK Study 
Secondary IDs if Any  
Secondary ID  Identifier 
2024 519883 42 00  EudraCT 
QL2107-102 Version 1.0 dated 03 March 2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ghanashyam Biswas 
Designation  Principal Investigator 
Affiliation  Sparsh Hospital and Critical Care P Ltd 
Address  Department of Oncology, A-407 Saheed Nagar Bhubaneswar
Orissa India
Khordha
ORISSA
751007
India 
Phone  9937500878  
Fax  9937500878  
Email  drgbiswas@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sumit Gupta  
Designation  Director 
Affiliation  Syneos Health India private Limited 
Address  4th Floor Block 2 DLF Downtown DLF City Phase 3 Rd Ambience Island DLF Phase 3 Sector 24 Gurugram Haryana

Gurgaon
HARYANA
122022
India 
Phone  9560453771  
Fax    
Email  sumit.gupta@syneoshealth.com   
 
Details of Contact Person
Public Query  
Name  Ataur Rahman 
Designation  Manager, Clinical Operations 
Affiliation  Syneos Health India private Limited 
Address  4th Floor Block 2 DLF Downtown DLF City Phase 3 Rd Ambience Island DLF Phase 3 Sector 24 Gurugram Haryana

Gurgaon
HARYANA
122022
India 
Phone  8532011805  
Fax    
Email  ataur.rahman@syneoshealth.com  
 
Source of Monetary or Material Support  
Qilu Pharmaceutical Co., Ltd. 
 
Primary Sponsor  
Name  Qilu Pharmaceutical Co., Ltd. 
Address  8888 Lvyou Road, Jinan, Shandong, China 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
Syneos Health India Pvt Ltd  4th Floor Block -2, DLF Downtown, Commercial Site, Block-V, DLF City, Phase III Sector 25A, Gurugram DLF Qe Gurugram (India) - 122002 
 
Countries of Recruitment     Bosnia and Herzegovina
China
Georgia
Greece
Hungary
India
Jordan
Poland
Romania
Spain
Thailand
Turkey
Viet Nam
Ukraine  
Sites of Study  
No of Sites = 8  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Nirmal Vivek Raut   Bhaktivedanta Hospital and Research Institute  Dept. of Oncology, Srishti Complex, Bhaktivedanta Swami Marg, Mira Road East, Thane
Thane
MAHARASHTRA 		 9930398156

drnirmalraut@gmail.com 
Dr Deepam Pushpam  Dr BRA Institute Rotary Cancer Hospital  Room No.229, Department of Medical Oncology, 2nd floor, Dr BRA Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, Anasari Nagar, New Delhi-110029
New Delhi
DELHI 		 9550629370

deepampushpam@gmail.com 
Dr Mukesh Chaudhari  HCG Manavata Cancer Centre  Dept. of Oncology, Behind Shivang Auto, Mumbai Naka, Nashik 422002
Nashik
MAHARASHTRA 		 9096920416

drmukesh@mcrinasik.com 
Dr Vijith Vittal Shetty  Justice K S Hegde Charitable Hospital  Department of Oncology, Department Number- 50, Mangalore University Road, Deralakatte, Mangalore-575018
Dakshina Kannada
KARNATAKA 		 8861796017

vshettyonco@gmail.com 
Dr Anshul Rajendraprasad Agarwal  Nirmal Hospital Pvt Ltd  Dept. of Oncology, Ring Road, Surat-395002, Gujarat, India
Surat
GUJARAT 		 9377113143

dranshulragarwal@gmail.com 
Dr Dipen Bhuva   PP Maniya Hospital Private Limited  Dept. of Medical Oncology, PP Maniya Hospital Private Limited, , Mamta Park Society-1, Opp. Dharuka College, Kapodra, Varachha Main Road, Surat - 395006
Surat
GUJARAT 		 7043516734

dipen.oncology@gmail.com 
Dr Shyam Aggarwal  Sir Ganga Ram Hospital  Block-E,5th floor, Ganga Ram Marg Old Rajinder Nagar New Delhi-110060
New Delhi
DELHI 		 9811075870

drshyam_aggarwal@yahoo.com 
Prof Ghanashyam Biswas  Sparsh Hospital & Critical Care (P) Ltd  Dept. of Oncology,A/407, Saheed Nagar, Bhubaneswar, Odisha, India, 751007
Khordha
ORISSA 		 9937500878

drgbiswas@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 8  
Name of Committee  Approval Status 
Bhaktivedanta Hospital Ethics Committee, Bhaktivedanta Hospital and Research institute Srishti Complex, Bhaktivedanta Swami Marg Mira Road (E) Thane Maharashtra - 401107  Approved 
Central Ethics Committee Nitte Deemed to be University University Enclave, Medical Science Complex, Mangalore-575018  Approved 
Institute Ethics Committee All India Institute of Medical Sciences, Old OT Block, Room No. 102, AIIMS Hospital, Ansari Nagar, New Delhi, Delhi -110029   Approved 
Institutional Ethics Committee Sparsh Hospitals and Critical Care Private Limited Plot No-A/407, Saheed Nagar, Bhubaneswar Khordha, Orissa - 751007  Approved 
Manavata Clinical Research Institute Ethics Committee, HCG Manavata Cancer Centre Behind Shivang Auto Mumbai Naka Nashik Nashik Maharashtra - 422002   Approved 
Nirmal Hospital Pvt Ltd Ethics Committee, Nirmal Hospital Pvt Ltd, Ring Road, Surat-395002, Gujarat,   Approved 
PP Maniya Hospital Ethics Committee PP Maniya Hospital Private Limited, Mamta Park Society 1, Opp Dharuka College, Kapodra, Varachha Main Road, Surat-395006   Approved 
Sir Ganga Ram Hospital Ethics Committee, room no.1643,6th floor, casualty Building, Sir Ganga Ram Hospital, SGRH Marg, Rajinder Nagar, New Delhi-110060  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J984||Other disorders of lung,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Keytruda®   Dose - 200 mg pembrolizumab per cycle Frequency - Once every 3 weeks (Q3W) for up to 17 cycles Route of Administration -Intravenous infusion Total Duration of Treatment -Approximately 12 months (17 cycles)  
Intervention  QL2107   Dose - 200 mg pembrolizumab per cycle Frequency - Once every 3 weeks (Q3W) for up to 17 cycles Route of Administration - Intravenous infusion Total Duration of Treatment- Approximately 12 months (17 cycles)  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Subjects who voluntarily participate have read understood and signed the informed consent form and are able to comply with the study procedures.
Adult subjects male or female more than equal to 18 years of age on the day of signing the informed consent form.
Disease status Subjects with completely resected histologically or cytologically confirmed Stage II or IIIA NSCLC as per the American Joint Committee on Cancer Eighth Edition. Complete resection R0 is achieved when resection margins are free systematic or lobe specific nodal dissection has been performed the highest lymph node station harvested is negative and there is no extracapsular nodal involvement.
Patients will be eligible to participate regardless of the level of PDL1 status. Patients should provide PDL1 reports or provide archived or fresh tissue samples for PDL1 tests which may be performed locally or in central laboratory. A tumor tissue sample obtained at surgical resection is preferred. Tumor samples obtained before NSCLC surgery are allowed only if the most recent biopsy tumor sample cannot be collected.
Treatment with platinum based chemotherapy. Chemotherapy must have begun within 12 weeks after the resection surgery. The last chemotherapy dose must have been completed at least 3 weeks and no more than 12 weeks before the subject is randomized.
No evidence of disease NSCLC for the post surgery baseline assessment must be documented by full chest abdomen pelvis computed tomography CT and or magnetic resonance imaging MRI and brain CT MRI within 12 weeks prior to the randomization date.
Eastern Cooperative Oncology Group performance status of 0 or 1. 
 
ExclusionCriteria 
Details  Surgical related adverse events or chemotherapy related toxicity not resolved to Grade One with the exception of Grade Two or less alopecia fatigue neuropathy and lack of appetite or nausea.
Subjects who have received systemic corticosteroids greater than ten milligrams prednisone daily or equivalent or other immunosuppressive drugs such as cyclophosphamide azathioprine methotrexate thalidomide or tumor necrosis factor alpha inhibitors within two weeks prior to the first dose. Note Inhaled or topical steroids and adrenal replacement steroids are permitted in the absence of an active autoimmune disorder.
Subjects with known epidermal growth factor receptor EGFR sensitive mutations or anaplastic lymphoma kinase ALK gene translocations are not allowed. Subjects must provide EGFR and ALK reports from previous histological or cytological tests. If no prior EGFR or ALK test has been performed archived tissue samples should be provided for EGFR and ALK tests which may be performed.
Received prior therapy with an anti cytotoxic T lymphocyte antigen four monoclonal antibody for example ipilimumab anti programmed cell death one PD One anti programmed cell death ligand one PD L One or anti programmed cell death ligand two PD L Two agent or agent directed to another stimulatory or co inhibitory T cell receptor.
Prior or planned neoadjuvant or adjuvant radiotherapy and or neoadjuvant chemotherapy for the current malignancy. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To demonstrate PK similarity in exposure after the initial dose and at steady state of QL2107 compared with Keytruda®
 		 Week 1
Week 19-22 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the maximum (peak) serum concentrations after the initial dose and at steady state as well as serum trough concentrations of QL2107 compared with Keytruda®  Week 1
Week 19
Week 4, 10, 13, 16, 19 and 28 
 
Target Sample Size   Total Sample Size="146"
Sample Size from India="20" 
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)   15/04/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/09/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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 is a randomized, double blind, parallel group, active controlled, multicenter study comparing QL2107 (pembrolizumab biosimilar candidate) with Keytruda as adjuvant monotherapy in subjects with resected Stage II to Stage IIIA non small cell lung cancer to demonstrate pharmacokinetic similarity at initial dose (area under the curve over the dosing interval at single dose) and steady state (area under the curve over the dosing interval at steady state). Dosing is 200 milligrams intravenously every three weeks for up to seventeen cycles, approximately one year. Secondary objectives include maximum concentration, trough concentration, immunogenicity, and safety; exploratory endpoint includes fifty two week disease free survival. Approximately one hundred forty six subjects across approximately fifty sites in Europe, Middle East, North Africa, and Asia (India planned).
 
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