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Идёт набор NCT05657873

A Study of Targeted Radiation Therapy in People With Non-Small Cell Lung Cancer (NSCLC)

Фаза II С лечением Non Small Cell Lung Cancer Non Small Cell Lung Cancer Metastatic Non-small Cell Carcinoma NSCLC

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: L-SABR, Anti-PD-(L)1 based immunotherapy, Platinum based chemotherapy.
Кому может быть актуально
Состояния в реестре: Non Small Cell Lung Cancer, Non Small Cell Lung Cancer Metastatic, Non-small Cell Carcinoma, NSCLC. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Phase II Trial of Hepatic Ablation of Metastases to Modulate and Enhance Immunotherapy Response (HAMMER) in NSCLC

Обзор

The purpose of this study is to see whether adding liver stereotactic ablative radiotherapy/L-SABR to standard drug therapy is better than standard drug therapy alone for people with metastatic non-small cell lung cancer/NSCLC.

Вмешательства

  • Лучевая терапия L-SABR
    L-SABR will be delivered in a week during which the patient receives no chemotherapy. L-SABR can be on the same week or even day as anti-PD-(L)1 therapy.
  • Биопрепарат Anti-PD-(L)1 based immunotherapy
    Standard of care treatment (anti-PD-(L)1 based immunotherapy +/- platinum based chemotherapy
  • Препарат Platinum based chemotherapy
    Standard of care treatment (anti-PD-(L)1 based immunotherapy +/- platinum based chemotherapy

Первичные конечные точки

  • Median progression-free survival [Срок оценки: up to 4 years]

Критерии участия

Критерии включения

  • Be greater than 18 years of age on day of signing informed consent.
  • Have a histologically confirmed diagnosis of stage IV NSCLC (includes patients who have progressed on durvalumab for Stage III NSCLC) without known mutations in (EGFR) or BRAF or rearrangements in ALK (anaplastic lymphoma kinase) or ROS-1.

o Patients with recurrent metastatic NSCLC following prior durvalumab for stage III disease are eligible provided this is their first immunotherapy course for metastatic disease (i.e., the planned anti-PD-(L)1-based regimen represents first-line systemic therapy in the metastatic setting).

  • Newly diagnosed metastatic non-small cell lung cancer (NSCLC), including both de novo and secondary metastatic disease, with one or more liver metastases
  • Plan to initiate standard of care anti-PD-(L)1 based immunotherapy +/- platinum based chemotherapy for at least 3 cycles

o Regimens combining anti-CTLA-4 immunotherapy with anti-PD-1 (e.g., ipilimumab plus nivolumab) or anti-PD-L1 (e.g., tremelimumab plus durvalumab) immunotherapy are allowed.

  • Have a performance status of 0-2 on the ECOG Performance Scale.
  • Liver function tests:
  • Total Bilirubin ≤ 1.5 x ULN
  • AST/ ALT ≤ 5 x ULN
  • Eligible for L- SABR to all liver metastases as determined by the treating radiation oncologist
  • Patients with known HIV are eligible provided they are under treatment with effective anti-retroviral therapy with CD4 count >200 cells/microliter within 28 days prior to registration

Критерии исключения

  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen should be included.
  • Patients with prior external beam radiation therapy to the liver.
  • Patients with known active Hepatitis B or Hepatitis C.
  • Patients with immunosuppression including pharmacological immunosuppression with chronic steroids or immune modulators like cyclosporin or methotrexate and patients with active autoimmune disease.
  • Patients who are pregnant or breastfeeding
  • Men or women not using effective contraception.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 9 центров
  • BAPTIST ALLIANCE - MCI (Data Collection Only) — Miami
  • Memorial Sloan Kettering at Basking Ridge (All Protocol Activities) — Basking Ridge
  • Memorial Sloan Kettering Monmouth (All Protocol Activities) — Middletown
  • Memorial Sloan Kettering Bergen (All protocol activities) — Montvale
  • Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities) — Commack
  • Memorial Sloan Kettering Westchester (All Protocol Activities) — Harrison
  • Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York
  • Memorial Sloan Kettering Nassau (All protocol activities) — Rockville Centre
  • … и ещё 1 центр

Публикации

  • McMillan MT, Reyngold M, Crane CH, O'Brien DAR, Williams VM, Zinovoy M, Cuaron JJ, Gonen M, Kaiser A, Sopka DM, Gomez DR, Schoenfeld AJ, Bott M, Romesser PB. A phase II trial of hepatic ablation of metastases to modulate and enhance immunotherapy response in non-small cell lung cancer (HAMMER-NSCLC). BMC Cancer. 2025 Sep 2;25(1):1408. doi: 10.1186/s12885-025-14779-5. PMID 40898159

Идентификаторы

NCT: NCT05657873 · 22-386

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗