Nintedanib for the Prevention of Radiation Pneumonia in Unresectable NSCLC

Официальное название

Prospective, Multicentre Phase II Clinical Study of Nintedanib for the Prevention of Radiation Pneumonia in Unresectable NSCLC

Обзор

This study is aimed at patients with unresectable NSCLC who take nintedanib during sequential radiotherapy to explore the incidence of radiation pneumonitis above grade 2 in the nintedanib combined with radiotherapy mode and observe safety. And will further explore the progression-free survival (PFS) and overall survival (OS) of patients treated with nintedanib in combination with radiotherapy and immunotherapy. Primary objective: To evaluate the safety of nintedanib combined with sequential radiotherapy in patients with unresectable NSCLC and the incidence of radiation pneumonitis above grade 2. Secondary objective: To evaluate the changes in lung function, progression-free survival (PFS) and overall survival (OS) in patients with unresectable NSCLC after nintedanib combined with sequential radiotherapy. Patients need to receive induction therapy, chemotherapy and/or immunotherapy for at least one cycle. Then they will receive sequential radiotherapy and nintedanib for 6 months. Finally, they will receive immunotherapy maintenance therapy for 16 cycles.

Вмешательства

• Препарат Nintedanib
  For patients with unresectable NSCLC, nidanib is administered during sequential radiotherapy

Первичные конечные точки

• security [Срок оценки: Up to 2 years]
• Incidence rate of radiation pneumonia [Срок оценки: Up to 2 years]

Вторичные конечные точки (3)

• Pulmonary function index [Срок оценки: Up to 2 years]
• Progression-free Survival (PFS) [Срок оценки: Up to 2 years]
• Overall Survival (OS) [Срок оценки: Up to 2 years]

Критерии участия

Критерии включения

• 1\) Men or women who are over 18 years old (including 18 years old) when signing the informed consent form;
• 2\) Non-small cell lung cancer was confirmed by histology and could not be resected, and EGFR/ALK driver gene was confirmed negative by gene mutation examination;
• 3\) At least one measurable lesion with imaging examination (according to RECIST1.1) is examined by spiral CT or MR, and the length and diameter of the lesion are ≥ 10 mm;
• 4\) within 3 days before treatment, the score according to ECOG is 0 \~ 1;
• 5\) Life expectancy ≥3 months;
• 6)The vital organs function well,
• 7)The subjects volunteered to join the study and signed the informed consent form, with good compliance and cooperation with the follow-up.

Критерии исключения

• 1\) Complicated with severe respiratory diseases: pulmonary fibrosis, active tuberculosis, etc.
• 2)Persons with mental disorder, blood system diseases, autoimmune diseases and serious primary diseases of heart, brain, liver and kidney;
• 3\) Hemorrhagic events that require blood transfusion, invasive intervention or hospitalization occur within 3 months before the first administration, or there are bleeding symptoms and need intervention treatment (such as hemoptysis, hematuria and bloody stool), or high-risk factors with bleeding risk (such as tumor surrounding or invading important blood vessels, obvious necrosis or cavity around tumor, esophageal varices, etc.);
• 4\) Thrombosis or embolic diseases, abnormal blood coagulation function and bleeding tendency;
• 5\) Known or suspected to be allergic to the study drug and its auxiliary materials;
• 6\) The baseline pregnancy test of pregnant and lactating women or fertile women is positive.
• 7\) According to the researcher's judgment, the subjects have other factors that may lead to the forced termination of this study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 7 центров

• Jincheng General Hospital — Jincheng
• Jinzhong third people's hospital — Jinzhong
• Frist Hospital of Shanxi Medical University — Taiyuan
• Second Hospital of Shanxi Medical University — Taiyuan
• Shanxi Bethune Hospital — Taiyuan
• Shanxi Hospital of Traditional Chinese Medicine — Taiyuan
• TISCO General Hospital — Taiyuan

Идентификаторы

NCT: NCT06570317 · [2024]YX No. 273

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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