A Study of AK104 in Subjects With Unresectable Locally Advanced NSCLC

Официальное название

A Randomized, Double-blind, Multicenter Phase III Study to Evaluate the Consolidation Therapy of AK104 Versus Sugemalimab in Patients With Unresectable Locally Advanced Non-Small Cell Lung Cancer Who Have Not Progressed After Concurrent or Sequential Chemoradiotherapy

Обзор

This study compares the efficacy and safety of AK104 versus Sugemalimab as consolidation therapy in patients with unresectable, locally advanced NSCLC who have not progressed following concurrent or sequential chemoradiotherapy.

Вмешательства

• Препарат Cadonilimab (AK104)
  AK104 ivgtt Q3W
• Препарат Sugemalimab
  1200mg Q3W

Первичные конечные точки

• Progression-free survival (PFS) assessed by INV [Срок оценки: 3 years]

Вторичные конечные точки (3)

• OS [Срок оценки: 5 years]
• 6-month PFS rate assessed by INV [Срок оценки: 3 years]
• AEs [Срок оценки: 3 years]

Критерии участия

Критерии включения

• Subjects must sign the written informed consent form (ICF) voluntarily.
• Age ≥18 years.
• Histologically or cytologically confirmed unresectable locally advanced (Stage III) NSCLC.
• Absence of known EGFR sensitive mutations and negative for ALK and ROS1 fusions.
• Concurrent or sequential chemoradiotherapy completed 1 to 42 days prior to the first dose.
• Chemotherapy regimens should be in accordance with current clinical guidelines.
• Consolidation chemotherapy is not allowed after radiotherapy.
• Total dose of radiotherapy is 60Gy±10% (54Gy-66Gy).
• No disease progression after concurrent or sequential chemoradiotherapy.
• ECOG performance status score of 0-1.
• Expected survival of over 3 months.
• Adequate organ and bone marrow function.

Критерии исключения

• The histopathology contains any component of small cell lung cancer.
• Currently participating in another interventional clinical study.
• Previously received immunotherapy, biotherapy, anti-angiogenic drugs, or small molecule targeted drugs.
• Patients with clinically significant cardio-cerebrovascular or venous thromboembolic diseases.
• Prior malignancy active within the previous 3 years except for the locally curable cancers that have been apparently cured.
• Tumor invades important vessels or organs.
• Experienced acute exacerbation of chronic obstructive pulmonary disease or asthma within 4 weeks prior to the first dose.
• Presence of interstitial lung disease that requires treatment.
• Toxicities of prior anticancer therapy have not resolved to ≤ Grade 1 (NCI-CTCAE version 5.0).
• Experienced severe infection within 4 weeks prior to the first dose.
• Underwent major surgery or experienced severe trauma within 4 weeks prior to the first dose.
• Any condition that required systemic treatment with corticosteroids (> 10 mg daily prednisone or equivalent) or other immunosuppressive agents within 14 days prior to the first dose.
• Active autoimmune diseases or history of autoimmune diseases that may relapse.
• Previous history of severe hypersensitivity reactions to other monoclonal antibodies.
• Previous organ transplantation or allogeneic hematopoietic stem cell transplantation.

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

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Cancer Hospital of Shandong First Medical University — Цзинань

Идентификаторы

NCT: NCT06617416 · AK104-309

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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