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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат QL2107
  IV infusion.
• Препарат Keytruda®
  IV infusion.

Первичные конечные точки

• AUCtau,sd of QL2107 and Keytruda [Срок оценки: At Cycle 1 (cycle length = 21 days)]]
• AUCtau,ss of QL2107 and Keytruda [Срок оценки: At Cycle 7 (cycle length = 21 days)]]

Вторичные конечные точки (5)

• Cmax,sd of QL2107 and Keytruda [Срок оценки: At Cycle 1 (cycle length = 21 days)]]
• Cmax,ss of QL2107 and Keytruda [Срок оценки: At Cycle 7 (cycle length = 21 days)]]
• Ctrough of QL2107 and Keytruda [Срок оценки: Up to Cycle 10 at Predose (cycle length = 21 days)]
• Number of Participants With Antidrug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) [Срок оценки: Up to Week 52]
• Number of Participants With Treatment-emergent Adverse Events (TEAEs) [Срок оценки: Up to Week 52]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07162883 · QL2107-102 · 2024-519883-42-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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