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Pharmacokinetic Study of QL2107 Versus Keytruda® for Adjuvant Therapy of Non-Small Cell Lung Cancer (NSCLC)
Sponsor: Qilu Pharmaceutical Co., Ltd.
Summary
The primary purpose of this study is to demonstrate Pharmacokinetic similarity in exposure after the initial dose and at steady state of QL2107 compared with Keytruda.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
146
Start Date
2025-11-21
Completion Date
2027-11-15
Last Updated
2026-10-22
Healthy Volunteers
No
Conditions
Interventions
QL2107
IV infusion.
Keytruda®
IV infusion.
Locations (84)
Clinical Center University of Sarajevo, Oncology Department
Sarajevo, Federation of BiH, Bosnia and Herzegovina
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, China
Peking University People's Hospital
Beijing, Beijing Municipality, China
Chinese People's Liberation Army Army Characteristic Medical Center)
Chongqing, Chongqing Municipality, China
Lanzhou University Second Hospital
Lanzhou, Gansu, China
Hainan Cancer Hospital
Haikou, Hainan, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Henan Provincial Chest Hospital
Zhengzhou, Henan, China
Hunan Cancer Hospital
Changsha, Hunan, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
First Affiliated Hospital of Gannan Medical University
Ganzhou, Jiangxi, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
Liaoning Cancer Hospital
Shenyang, Liaoning, China
Second Affiliated Hospital of the Air Force Medical University of the People's Liberation Army
Xi'an, Shaanxi, China
Shandong Province Qianfo Mountain Hospital
Jinan, Shandong, China
Affiliated Hospital of Jining Medical University
Jining, Shandong, China
Weifang People's Hospital
Weifang, Shandong, China
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
Shanxi Cancer Hospital
Taiyuan, Shanxi, China
Shanxi Provincial People's Hospital
Taiyuan, Shanxi, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Tianjin Chest Hospital
Tianjin, Tianjin Municipality, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
Yunnan Cancer Hospital
Kunming, Yunnan, China
Taizhou Center Hospital (Taizhou University Affiliated Hospital)
Taizhou, Zhejiang, China
Ltd "High Technology Hospital Medcenter"
Batumi, Adjara, Georgia
Ltd "Israel-Georgian Medical Research Clinic Helsicore"
Tbilisi, Georgia
Ltd "Todua Clinic"
Tbilisi, Georgia
Ltd "Tbilisi State Medical University and Ingorokva High Technology University Clinic
Tbilisi, Georgia
JSC "Vian"
Tbilisi, Georgia
General Hospital of Thessaloniki Papageorgiou
Thessaloniki, Central Macedonia, Greece
General Hospital of Thessaloniki G. Papanikolaou
Thessaloniki, Central Macedonia, Greece
Matrai Gyogyintezet, Matrahaza
Mátrahaza, Heves County, Hungary
Farkasgyepui Tudogyogyintezet
Farkasgyepü, Veszprém megye, Hungary
Nirmal Hospital Pvt Ltd - Clinical Research
Surat, Gujarat, India
P P Maniya Hospital Pvt Ltd
Surat, Gujarat, India
Justice K S Hegde Charitable Hospital
Mangalore, Karnataka, India
HCG Manavta Cancer Centre
Nashik, Maharashtra, India
Bhakti Vedanta Hospital and Research Institute
Thane, Maharashtra, India
All India Institute of Medical Science (AIIMS)
New Delhi, National Capital Territory of Delhi, India
Sir Ganga Ram Hospital
New Delhi, National Capital Territory of Delhi, India
Sparsh Hospitals Critical Care
Bhubaneswar, Odisha, India
Warmińsko-Mazurskie Centrum Chorób Płuc w Olsztynie
Olsztyn, Warmian-Masurian Voivodeship, Poland
NZOZ Neuromed M. i M. Nastaj Spółka Partnerska
Lublin, Poland
ARENSIA Exploratory Medicine, Oncology Institute Cluj-Napoca
Cluj-Napoca, Cluj, Romania
Centrul de Oncologie Sfantu Nectarie
Craiova, Dolj, Romania
ARENSIA Exploratory Medicine Bucharest, Romania
Bucharest, Romania
AI Clinical Research SRL
Sibiu, Romania
Complejo Hospitalario de Jaen
Jaén, Andalusia, Spain
Hospital Quirónsalud Málaga, Edificio Sur de Hospitalización
Málaga, Andalusia, Spain
Hospital Regional Universitario de Malaga
Málaga, Andalusia, Spain
Hospital Universitario Virgen del Rocio
Seville, Andalusia, Spain
Institut Catala d'Oncologia - Hospital Universitari Germans Trias i Pujol,
Badalona, Barcelona, Spain
HOSPITAL DEL MAR, UNITAT D'ASSAJOS CLÍNICS D'ONCOLOGIA Servei d'Oncologia Edifici C - Soterrani
Barcelona, Catalonia, Spain
Hospital Universitario Arnau de Vilanova, IRB Oncology
Lleida, Catalonia, Spain
Hospital General Universitario Dr. Balmis, Ensayos Oncología
Alicante, Valencia, Spain
Fundación Instituto Valenciano de Oncología
Valencia, Spain
Banphaeo General Hospital, Research Center
Ban Phaeo, Changwat Samut Sakhon, Thailand
Faculty of Medicine, Vajira Hospital, Navamindradhiraj University Medical Oncology Division
Bangkok, Thailand
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, Thailand
Faculty of Medicine, Chiang Mai University, Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, Thailand
Adana City Education and Research Hospital
Yüreğir, Adana, Turkey (Türkiye)
Baskent University Adana Dr Turgut Noyan Practice and Research Center
Adana, Turkey (Türkiye)
Medikal Park Seyhan Hospital
Adana, Turkey (Türkiye)
SBU Gulhane Egitim ve Arastirma Hastanesi
Ankara, Turkey (Türkiye)
Ankara University Medical Faculty
Ankara, Turkey (Türkiye)
Dicle University Medical Faculty Onkoloji Hastanesi Klinik
Diyarbakır, Turkey (Türkiye)
Koc University Hospital
Istanbul, Turkey (Türkiye)
Necmettin Erbakan University Department of Medical Oncology
Konya, Turkey (Türkiye)
Medical Park Ordu Hastanesi
Ordu, Turkey (Türkiye)
Sakarya University Training and Research Hospital Onkoloji hastanesi giriş kat ayaktan kemoterapi ünitesi
Sakarya, Turkey (Türkiye)
Regional Communal Noncommercial Enterprise Bukovinian Clinical Oncological Center
Chernivtsi, Chernivtsi Oblast, Ukraine
Medical Centre MedHouse
Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine
Saint Luke's Hospital - Acinus
Kropyvnytskyi, Kirovohrad Oblast, Ukraine
LLC Ukrainian Center of Tomotherapy
Kropyvnytskyi, Kirovohrad Oblast, Ukraine
Communal nonprofit enterprise - Podilsky Regional Oncology Center of the Vinnytsia Regional Council
Vinnytsia, Vinnytsia Oblast, Ukraine
"University clinic" of National Pirogov Memorial Medical University, Vinnytsya (Clinical, Educational, and Research Center)
Vinnytsia, Vinnytsia Oblast, Ukraine
LLC Medical Center "Altamedica"
Vinnytsia, Vinnytsia Oblast, Ukraine
Verum Clinic
Kyiv, Ukraine
Medical Center Universal Clinic Oberig of Limited Liability Company Kapytal
Kyiv, Ukraine
MedOffice Group Clinic
Kyiv, Ukraine
Nghe An Oncology Hospital
Vinh, Nghệ An Province, Vietnam
Hue Central Hospital
Huế, Thừa Thiên Huế Province, Vietnam