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ACTIVE NOT RECRUITING
NCT07162883
PHASE3

Pharmacokinetic Study of QL2107 Versus Keytruda® for Adjuvant Therapy of Non-Small Cell Lung Cancer (NSCLC)

Sponsor: Qilu Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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

Interventions

DRUG

QL2107

IV infusion.

DRUG

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