A Study of QL1706 Combined With Platinum-containing Chemotherapy in Adjuvant Treatment of Stage II-IIIB Non-small Cell Lung Cancer After Complete Surgical Resection.

Официальное название

QL1706 Combined With Platinum-based Chemotherapy Versus Placebo Combined With Platinum-based Chemotherapy as Adjuvant Therapy for Stage II-IIIB Non-small Cell Lung Cancer After Complete Surgical Resection: a Randomized, Double-blind, Multicenter Phase III Clinical Study.

Обзор

The purpose of this study is to evaluate the efficacy and safety of QL1706 combined with platinum-based chemotherapy versus placebo combined with platinum-based chemotherapy in adjuvant treatment of stage II-IIIB NSCLC without EGFR-sensitizing mutations and ALK fusions after complete surgical resection.The subjects were randomly divided into two groups according to 1:1, with about 316 subjects in the experimental group and the control group.

Вмешательства

• Препарат QL1706 injection
  QL1706(5mg/kg Q3W IV) concomitantly with Platinum-based chemotherapy
• Препарат Vinorelbine Tartrate
  Vinorelbine 25mg/m2（D1、D8）Q3W IV, 2-4 cycles
• Препарат Paclitaxel
  Paclitaxel 175mg/m2（D1） Q3W IV, 2-4 cycles
• Препарат Cisplatin
  Cisplatin 75mg/m2（D1）Q3W IV, 2-4 cycles
• Препарат Carboplatin
  Carboplatin AUC=5（D1） Q3W IV, 2-4 cycles
• Препарат Pemetrexed
  Pemetrexed 500mg/m2（D1） Q3W IV, 2-4 cycles
• Препарат Placebo
  Placebo

Первичные конечные точки

• Disease-free Survival (DFS) in the PD-L1 ≥1% Population, Assessed by Investigator. [Срок оценки: Up to approximately 84 months]
• Disease-free Survival (DFS) in the ITT Population, Assessed by Investigator. [Срок оценки: Up to approximately 84 months]

Вторичные конечные точки (6)

• Overall Survival (OS) [Срок оценки: Up to approximately 108 months]
• Percentage of Participants Who are Survival at Year 4 [Срок оценки: Year 4]
• Percentage of Participants Who are Disease-Free at Year 3 [Срок оценки: Year 3]
• Percentage of Participants Who are Disease-Free at Year 5 [Срок оценки: Year 5]
• DFS Within Selected Populations [Срок оценки: Up to approximately 108 months]
• Percentage of Participants with Adverse Events and Serious Adverse Events [Срок оценки: Up to approximately 108 months]

Критерии участия

Критерии включения

• Subjects voluntarily participated, signed an informed consent form (ICF), and were able to follow the study procedures.
• Histopathologically confirmed squamous or non-squamous non-small cell lung cancer
• Stage II-IIIB according to the 8th edition of the American Joint Committee on Cancer (AJCC) , and had received radical surgical resection (R0) treatment.
• Participants were enrolled to receive adjuvant therapy within 10 weeks after surgery (≤70 days) and had to recover sufficiently from surgery.
• Non-squamous NSCLC subjects without EGFR-sensitizing mutation or ALK fusion gene.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Subjects (including women and men) agreed to use effective contraception from the time of signing the informed consent to 180 days after the last use of the study drug.

Критерии исключения

• Currently participating in and receiving study treatment or participating in an investigational drug study and receiving study treatment or using an investigational device within 4 weeks prior to the first dose of study treatment.
• Previous treatment with neoadjuvant/adjuvant chemotherapy or immune checkpoint inhibitor therapy.
• Cardiovascular and cerebrovascular diseases with clinical significance.
• Gastrointestinal disease of clinical significance.
• Clinically significant lung damage.
• Human immunodeficiency virus (HIV) antibody positive; Treponema pallidum antibody positive.
• Active uncontrolled hepatitis B or active hepatitis C.
• Administer a live vaccine within 30 days prior to the first dose of study treatment.
• Other malignancies occurred within 5 years prior to study enrollment. (Except: Bowen's disease; cured basal cell or squamous cell skin cancer; prostate cancer with a Gleason score of 6; treated cervical carcinoma in situ.)
• Previously allergic to macromolecular protein preparations, or to any component of QL1706 and other investigational drugs; history of severe allergy to chemotherapy drugs (pemetrexed, vinorelbine, paclitaxel, cisplatin, carboplatin) or their preventive drugs, etc.
• History of psychotropic substance abuse, alcohol or drug abuse; prior history of clear neurological or psychiatric disorders, including epilepsy or dementia.

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

Китай · 1 центр

• Shanghai Pulmonary Hospital, Shanghai. China — Шанхай

Публикации

• Zhao Y, Ma Y, Zang A, Cheng Y, Zhang Y, Wang X, Chen Z, Qu S, He J, Chen C, Jin C, Zhu D, Li Q, Liu X, Su W, Ba Y, Hao Y, Chen J, Zhang G, Qu S, Li Y, Feng W, Yang M, Liu B, Ouyang W, Liang J, Yu Z, Kang X, Xue S, Yang G, Yan W, Yang Y, Liu Z, Peng Y, Fanslow B, Huang X, Zhang L, Zhao H. First-in-human phase I/Ib study of QL1706 (PSB205), a bifunctional PD1/CTLA4 dual blocker, in patients with adv PMID 37158938

Идентификаторы

NCT: NCT05487391 · QL1706-304

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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