Study on the Optimal Combination Pattern of the Combined Treatment of Radiotherapy and Immunotherapy for the Abscopal Effect in Non-Small Cell Lung Cancer (NSCLC) With Multiple Metastases

Официальное название

An Umbrella Trial of Combining Different Radiotherapy Fractionation Patterns With Immunotherapy for Multiple Metastases of Non-Small Cell Lung Cancer

Обзор

This study aims to conduct a prospective, multicenter, umbrella clinical study to compare the abscopal effects of different radiotherapy fractionation patterns combined with Benmelstobart, and to explore an efficient and low-toxic treatment strategy for non-small cell lung cancer (NSCLC) with multiple metastases. The main objective is to explore and compare the control rates of abscopal lesions in NSCLC patients with multiple metastases when different radiotherapy fractionation patterns are combined with Benmelstobart.

Вмешательства

• Препарат Benmelstobart combined with chemotherapy
  After 4 cycles of treatment with Benmelstobart combined with chemotherapy, if there is no progression, the patient will receive the treatment of 6-10Gy\*3-6F plus Benmelstobart.
• Препарат Benmelstobart combined with chemotherapy
  After 4 cycles of treatment with Benmelstobart combined with chemotherapy, if there is no progression and the largest lesion measures between 3 cm and 5 cm, the patient will receive the treatment of 3 Gy \* 15 fractions plus Benmelstobart.
• Препарат Benmelstobart combined with chemotherapy
  After 4 cycles of treatment with Benmelstobart combined with chemotherapy, if there is no disease progression and the largest lesion is larger than 5 cm, the patient will receive treatment with Spatial Fractionated Radiotherapy Technique (SFRT) plus Benmelstobart.
• Препарат Benmelstobart combined with chemotherapy
  After 4 cycles of treatment with Benmelstobart combined with chemotherapy, if there is no disease progression, and when the largest lesion is ≤ 3 cm and the patient can maintain the radiotherapy position for 50 minutes, the patient will receive treatment with the hyperfractionated pulsed radiotherapy technique (0.5 Gy \* 16 \* 6 fractions) plus Benmelstobart.
• Препарат Benmelstobart combined with chemotherapy
  After 4 cycles of treatment with Benmelstobart combined with chemotherapy, Benmelstobart is continued for maintenance treatment.
• Препарат Benmelstobart combined with Bevacizumab and chemotherapy
  For eligible subjects who have developed resistance to EGFR-TKI, after 4 cycles of treatment with Benmelstobart combined with Bevacizumab and chemotherapy, if there is no disease progression, they will receive the treatment of 6-10Gy \* 3-6 fractions plus Benmelstobart.

Первичные конечные точки

• The remission rate of abscopal lesions [Срок оценки: From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to approximately 2 years]

Вторичные конечные точки (3)

• PFS [Срок оценки: From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to approximately 2 years]
• OS [Срок оценки: up to 5 years]
• AE [Срок оценки: From date of consent informed until 60 days after the last investigational product administration. Up to approximately 2 years]

Критерии участия

Критерии включения

• Patient must meet all of the following inclusion criteria to be enrolled in this study:

• Non-small cell lung cancer confirmed by pathological histology.
• More than 3 metastatic lesions.
• No brain metastases or stable lesions.
• Negative for driver genes (including EGFR, ALK, ROS, BRAF, MET, RET).
• Performance status (PS) score of 0-1, with an expected survival period of more than 3 months.
• Age between 18 and 75 years old.
• Assessment by PET-CT (including FDG and FMISO, not mandatory).
• No contraindications to immunotherapy and radiotherapy.
• Signed the informed consent form.

Критерии исключения

• Patients with any of the following criteria are not eligible for enrollment in this study:

• Those with severe dysfunction of important vital organs (heart, liver, kidney).
• Those accompanied by other malignant tumors.
• Uncontrolled heart diseases or myocardial infarction within the past 6 months.
• Those with a history of mental illness.
• Other situations in which the researcher deems it inappropriate for the subject to participate 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

• the second affiliated hospital of Army medical university — Чунцин

Идентификаторы

NCT: NCT06953843 · XQonc-023

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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