CTRI/2026/03/106344尚未招募3 期
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
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 146
- 试验地点
- 8
- 主要终点
- To demonstrate PK similarity in exposure after the initial dose and at steady state of QL2107 compared with Keytruda®
研究概览
简要总结
This is a randomized, double blind, parallel group, active controlled, multicenter study comparing QL2107 (pembrolizumab biosimilar candidate) with Keytruda as adjuvant monotherapy in subjects with resected Stage II to Stage IIIA non small cell lung cancer to demonstrate pharmacokinetic similarity at initial dose (area under the curve over the dosing interval at single dose) and steady state (area under the curve over the dosing interval at steady state). Dosing is 200 milligrams intravenously every three weeks for up to seventeen cycles, approximately one year. Secondary objectives include maximum concentration, trough concentration, immunogenicity, and safety; exploratory endpoint includes fifty two week disease free survival. Approximately one hundred forty six subjects across approximately fifty sites in Europe, Middle East, North Africa, and Asia (India planned).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects who voluntarily participate have read understood and signed the informed consent form and are able to comply with the study procedures.
- •Adult subjects male or female more than equal to 18 years of age on the day of signing the informed consent form.
- •Disease status Subjects with completely resected histologically or cytologically confirmed Stage II or IIIA NSCLC as per the American Joint Committee on Cancer Eighth Edition.
- •Complete resection R0 is achieved when resection margins are free systematic or lobe specific nodal dissection has been performed the highest lymph node station harvested is negative and there is no extracapsular nodal involvement.
- •Patients will be eligible to participate regardless of the level of PDL1 status.
- •Patients should provide PDL1 reports or provide archived or fresh tissue samples for PDL1 tests which may be performed locally or in central laboratory.
- •A tumor tissue sample obtained at surgical resection is preferred.
- •Tumor samples obtained before NSCLC surgery are allowed only if the most recent biopsy tumor sample cannot be collected.
- •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 subject 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.
排除标准
- •Surgical related adverse events or chemotherapy related toxicity not resolved to Grade One with the exception of Grade Two or less alopecia fatigue neuropathy and lack of appetite or nausea.
- •Subjects who have received systemic corticosteroids greater than ten milligrams prednisone daily or equivalent or other immunosuppressive drugs such as cyclophosphamide azathioprine methotrexate thalidomide or tumor necrosis factor alpha inhibitors within two weeks prior to the first dose.
- •Note Inhaled or topical steroids and adrenal replacement steroids are permitted in the absence of an active autoimmune disorder.
- •Subjects with known epidermal growth factor receptor EGFR sensitive mutations or anaplastic lymphoma kinase ALK gene translocations are not allowed.
- •Subjects must provide EGFR and ALK reports from previous histological or cytological tests.
- •If no prior EGFR or ALK test has been performed archived tissue samples should be provided for EGFR and ALK tests which may be performed.
- •Received prior therapy with an anti cytotoxic T lymphocyte antigen four monoclonal antibody for example ipilimumab anti programmed cell death one PD One anti programmed cell death ligand one PD L One or anti programmed cell death ligand two PD L Two agent or agent directed to another stimulatory or co inhibitory T cell receptor.
- •Prior or planned neoadjuvant or adjuvant radiotherapy and or neoadjuvant chemotherapy for the current malignancy.
结局指标
主要结局
To demonstrate PK similarity in exposure after the initial dose and at steady state of QL2107 compared with Keytruda®
时间窗: Week 1 | Week 19-22
次要结局
- To evaluate the maximum (peak) serum concentrations after the initial dose and at steady state as well as serum trough concentrations of QL2107 compared with Keytruda®(Week 1)
研究者
Ghanashyam Biswas
Sparsh Hospital and Critical Care P Ltd
研究点 (8)
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