Impact of Radiotherapy-Immunotherapy Timing in NSCLC Brain Metastases

Официальное название

Immune Microenvironment-driven Radiotherapy-immunotherapy Combined With Time-series Strategy for NSCLC Brain Metastases: an Exploratory Study Based on a Clinical Cohort.

Обзор

The goal of this observational study is to learn about the effects of the timing of radiation therapy and immunotherapy in adults with non-small cell lung cancer (NSCLC) that has spread to the brain. The main questions it aims to answer are: 1. Does the timing of the two treatments change how long the brain tumor stays stable and how long participants live? 2. What medical problems do participants have when receiving these treatments at different times? 3. How does the timing of treatments affect the body's immune system? Researchers will compare participants who receive radiation and immunotherapy 30 days or less apart to those who receive them more than 30 days apart to see if the timing affects the treatment's success and safety. Participants already receiving radiation and immunotherapy as part of their regular medical care will: 1. Allow researchers to collect information about their treatment, health, and medical imaging during regular checkups. 2. Give a small blood sample during their routine blood draws. 3. Have standard magnetic resonance imaging (MRI) scans of their brain.

Вмешательства

• Лучевая терапия Brain radiotherapy
  Participants in this observational study receive standard-of-care radiotherapy for brain metastases combined with PD-1/PD-L1 immune checkpoint inhibitors. The specific radiotherapy parameters (e.g., technique, target volume, and dose) and immunotherapy details (e.g., specific drug type, dosage, and administration schedule) are entirely determined by the treating physicians or multidisciplinary team (MDT) based on current clinical guidelines and real-world practice. This study does not assign, a

Первичные конечные точки

• Intracranial Progression-Free Survival (iPFS) [Срок оценки: Up to approximately 2 years (Assessed every 2-3 months in the first year, and every 3-6 months thereafter until disease progression or death).]

Вторичные конечные точки (7)

• Intracranial Objective Response Rate (iORR) [Срок оценки: Up to approximately 2 years.]
• Overall Survival (OS) [Срок оценки: Up to approximately 2 years.]
• Duration of Response (DOR) [Срок оценки: Up to approximately 2 years.]
• Best Overall Response (BOR) [Срок оценки: Up to approximately 2 years.]
• Intracranial Disease Control Rate (iDCR) [Срок оценки: At 24 weeks]
• Incidence of Grade ≥3 Immune-Related Adverse Events (irAEs) [Срок оценки: From enrollment up to 1 years after the last dose of immunotherapy.]
• Incidence of Radiation Necrosis and Severe Brain Edema [Срок оценки: Up to approximately 2 years.]

Критерии участия

Критерии включения

• Age ≥ 18 years; no gender restriction;
• Histologically or cytologically confirmed NSCLC, with brain metastases confirmed by contrast-enhanced cranial MRI;
• Scheduled to receive radiotherapy combined with a PD-1/PD-L1 inhibitor, in accordance with real-world clinical treatment plans;
• Negative for driver gene mutations, or positive for mutations but with documented failure of prior targeted therapy;
• ECOG Performance Status score of 0-2, with an estimated life expectancy of ≥ 3 months;
• Voluntarily signs the informed consent form and agrees to cooperate with blood/imaging data collection and follow-up procedures.

Критерии исключения

• History of whole-brain radiotherapy, stereotactic radiotherapy for brain metastases, or brain surgery;
• Presence of contraindications to MRI or inability to tolerate gadolinium-based contrast agents (e.g., severe hepatic or renal insufficiency);
• Presence of active autoimmune disease requiring systemic treatment, or requirement for long-term use of high-dose immunosuppressive agents;
• Pregnant or lactating women;
• Other circumstances deemed by the investigator to involve severe complications or render the patient unsuitable for enrollment.

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 · 1 центр

• Xiangya Hospital of Central South University — Чанша

Идентификаторы

NCT: NCT07638709 · 2026051108 · ZXQ2026B05

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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