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Carcinoma, Non-Small-Cell LungPhase 3NCT07162883

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

A Phase 3 study testing QL2107 and Keytruda® in people with Carcinoma, Non-Small-Cell Lung, run by Qilu Pharmaceutical Co., Ltd. at 84 sites in 13 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
What is being tested?
QL2107 and Keytruda®
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
146 participants
Where
84 sitesin 13 countries
Study dates
21 Nov 2025to 15 Nov 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult participants (male or female) more than and equal to 18 years of age on the day of signing the ICF.
  • Disease status: Participants with completely resected, histologically- or cytologically-confirmed (Stage II or IIIA) NSCLC
  • 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 participant 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.

Who cannot join

  • Surgical-related adverse events (AEs) or chemotherapy-related toxicity not resolved to Grade 1, with the exception of Grade <=2 alopecia, fatigue, neuropathy, and lack of appetite/nausea.
  • Participants who have received systemic corticosteroids (more than [>] 10 mg prednisone daily or equivalent) or other immunosuppressive drugs (such as cyclophosphamide, azathioprine, methotrexate, thalidomide, or tumor necrosis factor alpha inhibitors) within 2 weeks prior to the first dose.
  • Participants with known epidermal growth factor receptor (EGFR)-sensitive mutations or anaplastic lymphoma kinase (ALK) gene translocations are not allowed.
  • Received prior therapy with an anticytotoxic T-lymphocyte antigen-4 mAb (example, ipilimumab); anti-programmed cell death 1 (PD-1), anti-programmed cell death ligand 1 (Programmed Death-Ligand 1), or anti-programmed cell death ligand 2 (PD-L2) agent; or agent directed to another stimulatory or co-inhibitory T cell receptor.
  • Participants with any active autoimmune disease or history of autoimmune diseases including but not limited to autoimmune hepatitis, interstitial pneumonia, pulmonary fibrosis, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, and hypothyroidism.

Trial locations and contacts

84 sites in 13 countries.

84 sites in 13 countries

China25 sites

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100035

  • The First Affiliated Hospital of Bengbu Medical University

    Bengbu, Anhui, 233000

  • Hunan Cancer Hospital

    Changsha, Hunan, 410000

  • Xiangya Hospital of Central South University

    Changsha, Hunan, 410000

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610000

  • Chinese People's Liberation Army Army Characteristic Medical Center)

    Chongqing, Chongqing Municipality, 400000

  • First Affiliated Hospital of Gannan Medical University

    Ganzhou, Jiangxi, 341000

  • Hainan Cancer Hospital

    Haikou, Hainan, 570100

  • Shandong Province Qianfo Mountain Hospital

    Jinan, Shandong, 250000

  • Affiliated Hospital of Jining Medical University

    Jining, Shandong, 272000

  • Yunnan Cancer Hospital

    Kunming, Yunnan, 650000

  • Lanzhou University Second Hospital

    Lanzhou, Gansu, 730030

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu, 210000

  • Shanghai Pulmonary Hospital

    Shanghai, Shanghai Municipality, 200000

  • The First Hospital of China Medical University

    Shenyang, Liaoning, 110000

  • Liaoning Cancer Hospital

    Shenyang, Liaoning, 110044

  • Shanxi Cancer Hospital

    Taiyuan, Shanxi, 030000

  • Shanxi Provincial People's Hospital

    Taiyuan, Shanxi, 030000

  • Taizhou Center Hospital (Taizhou University Affiliated Hospital)

    Taizhou, Zhejiang, 318000

  • Tianjin Chest Hospital

    Tianjin, Tianjin Municipality, 300000

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin Municipality, 300060

  • Weifang People's Hospital

    Weifang, Shandong, 261000

  • Second Affiliated Hospital of the Air Force Medical University of the People's Liberation Army

    Xi'an, Shaanxi, 710000

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450000

  • Henan Provincial Chest Hospital

    Zhengzhou, Henan, 450000

Other trials in China

Turkey (Türkiye)10 sites

  • Baskent University Adana Dr Turgut Noyan Practice and Research Center

    Adana, 01120

  • Medikal Park Seyhan Hospital

    Adana, 01140

  • SBU Gulhane Egitim ve Arastirma Hastanesi

    Ankara, 06020

  • Ankara University Medical Faculty

    Ankara, 06620

  • Dicle University Medical Faculty Onkoloji Hastanesi Klinik

    Diyarbakır, 21080

  • Koc University Hospital

    Istanbul, 34010

  • Necmettin Erbakan University Department of Medical Oncology

    Konya, 42090

  • Medical Park Ordu Hastanesi

    Ordu, 52200

  • Sakarya University Training and Research Hospital Onkoloji hastanesi giriş kat ayaktan kemoterapi ünitesi

    Sakarya, 54290

  • Adana City Education and Research Hospital

    Yüreğir, Adana, 01230

Other trials in Turkey (Türkiye)

Ukraine10 sites

  • Regional Communal Noncommercial Enterprise Bukovinian Clinical Oncological Center

    Chernivtsi, Chernivtsi Oblast, 58013

  • Medical Centre MedHouse

    Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018

  • Saint Luke's Hospital - Acinus

    Kropyvnytskyi, Kirovohrad Oblast, 25006

  • LLC Ukrainian Center of Tomotherapy

    Kropyvnytskyi, Kirovohrad Oblast, 25011

  • Verum Clinic

    Kyiv, 03039

  • Medical Center Universal Clinic Oberig of Limited Liability Company Kapytal

    Kyiv, 03057

  • MedOffice Group Clinic

    Kyiv, 03189

  • Communal nonprofit enterprise - Podilsky Regional Oncology Center of the Vinnytsia Regional Council

    Vinnytsia, Vinnytsia Oblast, 21000

  • "University clinic" of National Pirogov Memorial Medical University, Vinnytsya (Clinical, Educational, and Research Center)

    Vinnytsia, Vinnytsia Oblast, 21001

  • LLC Medical Center "Altamedica"

    Vinnytsia, Vinnytsia Oblast, 21036

Other trials in Ukraine

Spain9 sites

  • Hospital General Universitario Dr. Balmis, Ensayos Oncología

    Alicante, Valencia, 03010

  • Institut Catala d'Oncologia - Hospital Universitari Germans Trias i Pujol,

    Badalona, Barcelona, 08916

  • HOSPITAL DEL MAR, UNITAT D'ASSAJOS CLÍNICS D'ONCOLOGIA Servei d'Oncologia Edifici C - Soterrani

    Barcelona, Catalonia, 08003

  • Complejo Hospitalario de Jaen

    Jaén, Andalusia, 23007

  • Hospital Universitario Arnau de Vilanova, IRB Oncology

    Lleida, Catalonia, 25198

  • Hospital Quirónsalud Málaga, Edificio Sur de Hospitalización

    Málaga, Andalusia, 29004

  • Hospital Regional Universitario de Malaga

    Málaga, Andalusia, 29010

  • Hospital Universitario Virgen del Rocio

    Seville, Andalusia, 41013

  • Fundación Instituto Valenciano de Oncología

    Valencia, 46009

Other trials in Spain

India8 sites

  • Sparsh Hospitals Critical Care

    Bhubaneswar, Odisha, 751007

  • Justice K S Hegde Charitable Hospital

    Mangalore, Karnataka, 575018

  • HCG Manavta Cancer Centre

    Nashik, Maharashtra, 422002

  • All India Institute of Medical Science (AIIMS)

    New Delhi, National Capital Territory of Delhi, 110029

  • Sir Ganga Ram Hospital

    New Delhi, National Capital Territory of Delhi, 110060

  • Nirmal Hospital Pvt Ltd - Clinical Research

    Surat, Gujarat, 395002

  • P P Maniya Hospital Pvt Ltd

    Surat, Gujarat, 395002

  • Bhakti Vedanta Hospital and Research Institute

    Thane, Maharashtra, 401017

Other trials in India

Georgia5 sites

  • Ltd "High Technology Hospital Medcenter"

    Batumi, Adjara, 06000

  • Ltd "Israel-Georgian Medical Research Clinic Helsicore"

    Tbilisi, 00112

  • Ltd "Todua Clinic"

    Tbilisi, 00112

  • Ltd "Tbilisi State Medical University and Ingorokva High Technology University Clinic

    Tbilisi, 00144

  • JSC "Vian"

    Tbilisi, 00159

Other trials in Georgia

Romania4 sites

  • ARENSIA Exploratory Medicine Bucharest, Romania

    Bucharest, 22328

  • ARENSIA Exploratory Medicine, Oncology Institute Cluj-Napoca

    Cluj-Napoca, Cluj, 400015

  • Centrul de Oncologie Sfantu Nectarie

    Craiova, Dolj, 200542

  • AI Clinical Research SRL

    Sibiu

Other trials in Romania

Thailand4 sites

  • Banphaeo General Hospital, Research Center

    Ban Phaeo, Changwat Samut Sakhon, 74120

  • Faculty of Medicine, Vajira Hospital, Navamindradhiraj University Medical Oncology Division

    Bangkok, 10300

  • Faculty of Medicine Siriraj Hospital, Mahidol University

    Bangkok, 10700

  • Faculty of Medicine, Chiang Mai University, Maharaj Nakorn Chiang Mai Hospital

    Chiang Mai, 50200

Other trials in Thailand

Greece2 sites

  • General Hospital of Thessaloniki Papageorgiou

    Thessaloniki, Central Macedonia, 56429

  • General Hospital of Thessaloniki G. Papanikolaou

    Thessaloniki, Central Macedonia, 57010

Other trials in Greece

Hungary2 sites

  • Farkasgyepui Tudogyogyintezet

    Farkasgyepü, Veszprém megye, 08582

  • Matrai Gyogyintezet, Matrahaza

    Mátrahaza, Heves County, 03200

Other trials in Hungary

Poland2 sites

  • NZOZ Neuromed M. i M. Nastaj Spółka Partnerska

    Lublin, 20-064

  • Warmińsko-Mazurskie Centrum Chorób Płuc w Olsztynie

    Olsztyn, Warmian-Masurian Voivodeship, 10-357

Other trials in Poland

Vietnam2 sites

  • Hue Central Hospital

    Huế, Thừa Thiên Huế Province, 50999

  • Nghe An Oncology Hospital

    Vinh, Nghệ An Province, 43133

Other trials in Vietnam

Bosnia and Herzegovina1 site

  • Clinical Center University of Sarajevo, Oncology Department

    Sarajevo, Federation of BiH, 71000

Other trials in Bosnia and Herzegovina

About this study

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

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.

Being tested
QL2107, Keytruda®
Keywords
Respiratory Tract Neoplasms, Thoracic Neoplasms, Neoplasms by Site, Neoplasms, Lung Diseases, Respiratory Tract Diseases, Carcinoma, Bronchogenic, Bronchial Neoplasms, Neoplasm Metastasis, Neoplastic Processes, Pathologic Processes, Lung Neoplasms, Lymphatic Metastasis
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Respiratory Tract Neoplasms, Thoracic Neoplasms, Neoplasms by Site, Neoplasms, Lung Diseases, Respiratory Tract Diseases, Carcinoma, Bronchogenic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QL2107Drug

    Also called Pembrolizumab biosimilar candidate

    IV infusion.

  • Keytruda®Drug

    Also called Pembrolizumab

    IV infusion.

Study groups in NCT07162883
Study groupRoleWhat they receive
QL2107 200mgExperimentalParticipants will receive QL2107 200 milligrams (mg) intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21 days treatment cycle for up to 17 treatment cycles.
Receives: Drug: QL2107
Keytruda® 200 mgActive comparatorParticipants will receive Keytruda® 200 mg IV infusion Q3W, on Day 1 of each 21- days treatment cycle for up to 17 treatment cycles.
Receives: Drug: Keytruda®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AUCtau,sd of QL2107 and Keytruda

    Area under the concentration time curve for 1 dosing interval (tau = 21 days) after a single initial) dose (AUCtau,sd) of QL2107 and Keytruda® will be reported.

    Measured: At Cycle 1 (cycle length = 21 days)]

  2. AUCtau,ss of QL2107 and Keytruda

    Area under the concentration time curve for 1 dosing interval (tau = 21 days) at steady state (AUCtau,ss) of QL2107 and Keytruda® will be reported.

    Measured: At Cycle 7 (cycle length = 21 days)]

Secondary outcomes (5)

  1. Cmax,sd of QL2107 and Keytruda

    Maximum (peak) serum concentration after a single dose (Cmax,sd) of QL2107 and Keytruda® will be reported.

    Measured: At Cycle 1 (cycle length = 21 days)]

  2. Cmax,ss of QL2107 and Keytruda

    Maximum (peak) serum concentration at steady state (Cmax,ss) of QL2107 and Keytruda® will be reported.

    Measured: At Cycle 7 (cycle length = 21 days)]

  3. Ctrough of QL2107 and Keytruda

    The trough serum concentration measured before the next dose is administered (Ctrough) of QL2107 and Keytruda® (predose samples) will be reported.

    Measured: Up to Cycle 10 at Predose (cycle length = 21 days)

  4. Number of Participants With Antidrug Antibodies (ADAs) and Neutralizing Antibodies (NAbs)

    Measured: Up to Week 52

  5. Number of Participants With Treatment-emergent Adverse Events (TEAEs)

    Measured: Up to Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2025
  2. Study start21 Nov 2025
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion15 Nov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
146 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07162883
Sponsor's protocol ID
QL2107-102
Other IDs
2024-519883-42-00
Status last verified
Jun 2026
First submitted
31 Aug 2025
Last updated
22 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing QL2107 and Keytruda® in people with Carcinoma, Non-Small-Cell Lung, run by Qilu Pharmaceutical Co., Ltd. at 84 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 84 sites in China, Turkey (Türkiye), Ukraine, Spain, India and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AUCtau,sd of QL2107 and Keytruda (time frame: At Cycle 1 (cycle length = 21 days)]). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07162883.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.

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