Anlotinib Plus Immune Checkpoint Inhibitors for Lung Cancer

Официальное название

Anlotinib With or Without Immune Checkpoint Inhibitors in Standard Chemo-immunotherapy Failed Advanced Non-small Cell Lung Cancer

Обзор

This study aims to explore the efficacy of Anlotinib with or without Immune Checkpoint Inhibitor in Standard Chemo-immunotherapy Failed Advanced NSCLC.

Подробное описание

This study aims to explore the efficacy of Anlotinib with or without Immune Checkpoint Inhibitor in Standard Chemo-immunotherapy Failed Advanced NSCLC. The primary endpoint was PFS.

Вмешательства

• Препарат Anlotinib plus the same Immune Checkpoint Inhibitors.
  Anlotinib, 8mg po qd, D1-D14 every 21days.
• Препарат Anlotinib plus the new Immune Checkpoint Inhibitors.
  Anlotinib, 8mg po qd, D1-D14 every 21days.
• Препарат Anlotinib
  Anlotinib, 8mg po qd, D1-D14 every 21days.

Первичные конечные точки

• Progression free survival time (PFS) [Срок оценки: Time from first subject dose to study completion, or up to 36 month.]

Вторичные конечные точки (2)

• Objective Response Rate (ORR) [Срок оценки: Time from first subject dose to study completion, or up to 36 month.]
• Overall survival (OS) [Срок оценки: Time from first subject dose to study completion, or up to 36 month.]

Критерии участия

Критерии включения

• Understand the requirements and contents of the clinical trial, and provide a signed and dated informed consent form.
• Age ≥ 18 years.
• Histopathology or cytology confirmed lung cancer
• Failed from first line Chemo-immunotherapy.
• ECOG 0-1.
• Predicted survival ≥ 12 weeks.
• Adequate bone marrow hematopoiesis and organ function
• Presence of measurable lesions according to RECIST 1.1.
• Subjects with stable brain metastases may be included in the study.

Критерии исключения

• Subjects who have received any of the following treatments must be excluded:

• Treatment with molecules such as EGFR, VEGFR antibodies within 4 weeks prior to the first dose of study drug.
• Have received radiation within 14 days prior to the first dose or have not recovered from radiation-related toxicity. Chest and extra-brain palliative radiotherapy, stereotactic radiosurgery, and stereotactic body radiotherapy may be performed 7 days prior to the first dose.
• Ongoing (or inability to discontinue) possibly potent CYP1A2, CYP3A inhibitor (1 week), or inducer (2 weeks) drug therapy or herbal supplements within 1-2 weeks prior to the first dose.
• Presence of spinal cord compression or meningeal metastasis.
• History of other malignant tumors within 2 years.
• Adverse events (except alopecia of any degree) of CTCAE > grade 1 due to prior treatment (e.g., adjuvant chemotherapy, radiotherapy, etc.) prior to the first dose.
• History of stroke or intracranial hemorrhage within 6 months prior to the first dose.
• The presence of any severe or poorly controlled systemic disease, including poorly controlled hypertension and active bleeding in the judgment of the investigator.
• Subjects with persistent or active infection, including but not limited to hepatitis B (HBV), hepatitis C (HCV), human immunodeficiency virus (HIV) and COVID-19 infection.
• Heart-related diseases or abnormalities
• Past history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid therapy or interstitial lung disease with active clinical symptoms, immune pneumonia caused by immunotherapy.
• Refractory nausea and vomiting, chronic gastrointestinal disease, difficulty swallowing drugs, or inability to adequately absorb sunvozertinib or anlotinib due to previous bowel resection.
• Live vaccine was given 2 weeks before the first medication.
• Women who are breastfeeding or pregnant.
• Hypersensitivity to the test drug and the ingredients.
• Other conditions assessed by the investigator to be unsuitable for participation in the study.

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

• Yongchang Zhang — Чанша

Идентификаторы

NCT: NCT04322617 · 20200113

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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