Radiotherapy Plus Anlotinib in LA-NSCLC Intolerable to cCRT

Официальное название

Efficiency and Safety of Radiotherapy Combined With Anlotinib in Locally Advanced Non-small Cell Lung Cancer Patients Intolerable to Concurrent Chemoradiotherapy: A Phase II Single-arm Trial

Обзор

Concurrent chemoradiotherapy (cCRT) is the standard treatment for patients with negative epidermal growth factor receptor (EGFR)-mutated unresectable locally advanced non-small cell lung cancer (LA-NSCLC). However, parts of patients only receive sequential chemoradiotherapy (sCRT) due to various reasons. This phase II study aimed to improve the outcomes of patients receiving sCRT by combining anti-angiogenesis therapy (Anlotinib) during radiotherapy course.We hypothesize that the combination of radiotherapy with anlotinib could improve the 2-year PFS rate from 35% with sCRT to 50. The accrual target was 44 patients.

Вмешательства

• Препарат Anlotinib
  For patients treated with conventional Intensity-Modulated Radiation Therapy (IMRT), the median prescribed dose was 60 Gy/30 fractions (range: 50.0-70.0 Gy, in 25-35 fractions) (median BED10 72 Gy, range: 60-84 Gy) to the planning target volume (PTV). As for patients with IMRT-based simultaneously integrated boost (SIB), the median prescribed dose was 59.92 Gy/28 fractions (range: 50.0-70.0 Gy, in 25-33 fractions) (median BED10 72.74 Gy, range: 60-84 Gy) to the planning gross tumor volume (PGTV)

Первичные конечные точки

• 2-year progression-free survival (PFS) [Срок оценки: From the first day of radiotherapy to the occurrence of objective tumor progression or death due to any cause, whichever occurs first, assessed up to 60 months]

Вторичные конечные точки (4)

• Overall Survival(OS) [Срок оценки: From the first day of radiotherapy to the occurrence of death due to any cause, assessed up to 60 months]
• Local regional recurrence (LR) [Срок оценки: From the first day of radiotherapy to the occurrence of clinical and/or biopsy-proven recurrence within the bronchial stump, ipsilateral hilum, mediastinum, or supraclavicular, whichever occurs first, assessed up to 60 months]
• Distant metastasis (DM) [Срок оценки: From the first day of radiotherapy to the occurrence of any evidence of metastatic disease beyond the locoregional regions previously mentioned, assessed up to 60 months]
• Acute toxicity [Срок оценки: From the first day of radiotherapy and up to the 3-month post-radiotherapy follow-up visit]

Критерии участия

Patients with histologically or cytologically confirmed negative EGFR (including EGFR exon 19 deletion or L858R mutations) or ALK/ROS1-mutated locally advanced unresectable NSCLC were screened.

Критерии включения

• ≥18 years old with no restrictions on sex;
• Peripheral tumor, or central lung cancer with non-squamous tissue or a mixed tissue with less than 50% squamous carcinoma;
• Eastern cooperative oncology group (ECOG) score ≤2 was required;
• Received systemic chemotherapy or combined chemotherapy and immumitherapy for ≥ 4 weeks without progression;
• .No cavity inside the tumor, and located ≥ 1 cm of the main pulmonary artery trunk;
• No symptoms of hemoptysis;
• Adequate hepatic and renal functions with a negative urine protein;
• Expected survival of more than 6 months.

Критерии исключения

• currently receiving treatment for malignancies at other sites, except for curable non-melanoma skin cancer and cervical carcinoma in situ;
• previous malignancy within five years;
• thoracic radiotherapy history, hemoptysis, myocardial infarction or cerebrovascular accident within three months;
• uncontrolled or active pulmonary inflammation;
• participated in other clinical trials;
• Pregnant women.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Department of Radiation Oncology,Cancer Institute and Hospital,Chinese — Пекин

Публикации

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Идентификаторы

NCT: NCT07037680 · NCC2827

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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