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Active, not recruiting Phase 3

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

NCT07162883 · tracked via the Priya Life Science Poland tracker
Phase
Phase 3
Started
2025-11-21
Last updated
2026-10-22

Condition(s) studied

Carcinoma, Non-Small-Cell Lung

Investigational drug(s) / intervention(s)

QL2107 →Keytruda® →

QL2107: IV infusion.

Keytruda®: IV infusion.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

  • AUCtau,sd of QL2107 and Keytruda — At Cycle 1 (cycle length = 21 days)]
    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.
  • AUCtau,ss of QL2107 and Keytruda — At Cycle 7 (cycle length = 21 days)]
    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.

Trial sites (84)

FacilityCityRegionStatus
Clinical Center University of Sarajevo, Oncology Department Sarajevo Federation of BiH
The First Affiliated Hospital of Bengbu Medical University Bengbu Anhui
Peking University People's Hospital Beijing Beijing Municipality
Chinese People's Liberation Army Army Characteristic Medical Center) Chongqing Chongqing Municipality
Lanzhou University Second Hospital Lanzhou Gansu
Hainan Cancer Hospital Haikou Hainan
Henan Cancer Hospital Zhengzhou Henan
Henan Provincial Chest Hospital Zhengzhou Henan
Hunan Cancer Hospital Changsha Hunan
Xiangya Hospital of Central South University Changsha Hunan
Nanjing Drum Tower Hospital Nanjing Jiangsu
First Affiliated Hospital of Gannan Medical University Ganzhou Jiangxi
The First Hospital of China Medical University Shenyang Liaoning
Liaoning Cancer Hospital Shenyang Liaoning
Second Affiliated Hospital of the Air Force Medical University of the People's Liberation Army Xi'an Shaanxi
Shandong Province Qianfo Mountain Hospital Jinan Shandong
Affiliated Hospital of Jining Medical University Jining Shandong
Weifang People's Hospital Weifang Shandong
Shanghai Pulmonary Hospital Shanghai Shanghai Municipality
Shanxi Cancer Hospital Taiyuan Shanxi
Shanxi Provincial People's Hospital Taiyuan Shanxi
West China Hospital of Sichuan University Chengdu Sichuan
Tianjin Chest Hospital Tianjin Tianjin Municipality
Tianjin Medical University Cancer Institute & Hospital Tianjin Tianjin Municipality
Yunnan Cancer Hospital Kunming Yunnan
Taizhou Center Hospital (Taizhou University Affiliated Hospital) Taizhou Zhejiang
Ltd "High Technology Hospital Medcenter" Batumi Adjara
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
General Hospital of Thessaloniki G. Papanikolaou Thessaloniki Central Macedonia
Matrai Gyogyintezet, Matrahaza Mátrahaza Heves County
Farkasgyepui Tudogyogyintezet Farkasgyepü Veszprém megye
Nirmal Hospital Pvt Ltd - Clinical Research Surat Gujarat
P P Maniya Hospital Pvt Ltd Surat Gujarat
Justice K S Hegde Charitable Hospital Mangalore Karnataka
HCG Manavta Cancer Centre Nashik Maharashtra
Bhakti Vedanta Hospital and Research Institute Thane Maharashtra

+ 44 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07162883 on ClinicalTrials.gov ↗ ← All trials in Poland