Golidocitinib in Combination With Sintilimab for PD-L1 Selected Treatment Locally Advanced or Metastatic Non-Small Cell Lung Cancer(NSCLC)

Официальное название

A Phase 2, Open-label, Single Arm Study to Investigate the Safety and Efficiency of Golidocitinib in Combination With Sintilimab in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With PD-L1TPS ≥ 1%)

Обзор

This is a phase 2 Study to investigate the safety, tolerability, and anti-tumor activity of golidocitinib in combination with sintilimab as the front-line treatment for patients with metastatic PD-L1 positive non-small cell lung cancer (NSCLC)

Вмешательства

• Препарат Golidocitinib
  Daily dosing of golidocitinib
• Препарат Sintilimab
  Sintilimab, 200mg, intravenous, every 3 weeks.
• Препарат platinum doublet chemotherapy
  Pemetrexed or nab-paclitaxel +carboplatin, intravenous, every 3 weeks for 2 cycles

Первичные конечные точки

• Overall response rate (ORR) (cohort1) [Срок оценки: through study completion, an average of 1 year]
• Progression-free survival (PFS) (cohort2) [Срок оценки: through study completion, an average of 1 year]

Вторичные конечные точки (2)

• Overall survival (OS) [Срок оценки: through study completion, up to 36 months]
• Incidence of Adverse Events [Срок оценки: through study completion, up to 36 months]

Критерии участия

Критерии включения

• Be able to provide a signed and dated, written informed consent.
• Adults aged ≥18 to 75 years.
• ECOG performance status 0-1.
• Predicted life expectancy ≥ 12 weeks
• Histologically or cytologically confirmed non-small-cell lung cancer (NSCLC) , Stage IIIB/IIIC (not suitable for concomitant chemoradiotherapy) or Stage IV according to AJCC 8th
• Without EGFR or ALK mutations.
• Adequate bone marrow reserve and organ system functions.
• Patients with stable and symptomatic brain metastasis (BM) can be enrolled.

Part A Dose escalation:

Patients must have relapsed after or been refractory/intolerant to ≥ 1 prior systemic therapy(ies) for NSCLC

Part B dose expansion:

• At least one measurable lesion according to RECIST 1.1.
• Previously systemic untreated for advanced disease.
• PD-L1 TPS ≥ 50% (cohort 1), PD-L1 TPS 1-49% (cohort 2)

Критерии исключения

• Histopathology confirmed a mixture of NSCLC and small-cell lung cancer
• Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
• Prior malignancy within 5 years
• History of organ transplantation or hematopoietic stem cell transplantation
• Sever lung function decline or interstitial lung disease that has required oral or IV steroids
• Active autoimmune disease requiring systemic therapy within 2 years
• Immunodeficiency, or being treated with immunosuppressive therapy (including systemic glucocorticoid) within 7 days prior to the first dose of study treatment.
• Active infections
• Significant cardiac disorder
• Other serious or uncontrolled systemic diseases assessed by the investigator.

Part A Dose escalation:

1\. Prior systemic therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or stimulatory or synergistic T-cell receptor (CTLA-4、OX-40、CD137) within 4 weeks

Part B Dose Expansion:

• Any prior systemic anti-tumor therapy
• Prior systemic immunotherapy, including anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or stimulatory or synergistic T-cell receptor (CTLA-4、OX-40、CD137)

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences — Пекин

Идентификаторы

NCT: NCT06198907 · DZ2023J0002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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