Clinical Trials in Poland / NCT07162883
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
Condition(s) studied
Carcinoma, Non-Small-Cell Lung
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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.
Other trials for the same condition
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