Sequential Chemo-immunotherapy Plus Thoracic Radiotherapy for Elderly And/or Frail Stage III Non-small-cell Lung Cancer

Официальное название

Sequential Chemo-immunotherapy Plus Thoracic Radiotherapy for Elderly And/or Frail Stage III Non-small-cell Lung Cancer Patients Unfit for Concurrent Chemoradiotherapy: an Open Label, Two Cohorts, Prospective Trial

Обзор

Concurrent chemoradiotherapy without disease progression followed by consolidation durvalumab is standard of care for unresectable, stage III non-small-cell lung cancer (NSCLC) (the 'PACIFIC regimen'). However, many patients with poor performance status, older age or comorbidities may be ineligible for chemotherapy due to expected high toxicity. The present study aim to investigate the efficacy and toxicities of sequential chemo-immunotherapy plus thoracic radiotherapy for elderly and/or frail stage III NSCLC patients unfit for concurrent chemoradiotherapy, and to identify the optimal thoracic dose for this patient population.

Вмешательства

• Лучевая терапия standar thoracic RT dose
  All the enrolled patients will be patients with NSCLC who did not have PD (determined as per the RECIST v1.1) after 4-6 cycle of platinum-based chemotherapy in combination with an anti-PD-1/L1. Then, those enrolled patients would be treated with standard dose thoracic radiotherapy of 60 Gy/30Fx concurrently with PD-1/PD-L1 maintenance therapy, and the total maintenance therapy time should at least more than 6 months.
• Лучевая терапия decreased thoracic RT dose
  All the enrolled patients will be patients with NSCLC who did not have PD (determined as per the RECIST v1.1) after 4-6 cycle of platinum-based chemotherapy in combination with an anti-PD-1/L1. Then, those enrolled patients would be treated with decreased thoracic radiotherapy of 50Gy/25Fx concurrently with PD-1/PD-L1 maintenance therapy, and the total maintenance therapy time should at least more than 6 months.

Первичные конечные точки

• progression-free survival [Срок оценки: 12 months after last patient entry]

Вторичные конечные точки (3)

• 1-year overall survial [Срок оценки: 12 months after last patient entry]
• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 within one year [Срок оценки: 12 months after last patient entry]
• 5-year overall survival [Срок оценки: 5-years after last patient entry]

Критерии участия

Критерии включения

• Age ≥18 years at time of study entry
• Histologically documented diagnosis of unresectable stage III NSCLC;
• Fully-informed written consent obtained from patients;
• Unfit for concurrent chemoradiotherapy as determined by the multi-disciplinary team board due to one of the following reasons: (1) ECOG 2; (2)age≥70;(3) ECOG 1 and CCI≥1；
• Adequate bone marrow, liver and kidney function
• Life expectancy of at least 3 months
• At least one measurable (RECIST 1.1), thoracic lesion that can be irradiated
• Histologic or cytologic confirmation of small cell lung cancer
• Adequate pulmonary function with FEV1 >1 L or >30 % of predicted value and DLCO >30 % of predicted value

Критерии исключения

• Previous chemo-, immuno- or radiotherapy for NSCLC
• Major surgical procedure last 28 days
• History of allogenic organ transplantation, autoimmune disease, immunodeficiency, hepatitis or HIV
• Uncontrolled intercurrent illness
• Other active malignancy
• Leptomeningeal carcinomatosis
• Immunosuppressive medication
• Pregnant or breastfeeding women

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

Китай · 1 центр

• Ruijin Hospital, Shanghai jiaotong univestigy school of medicine — Шанхай

Публикации

• Qi WX, Li S, Wang M, Li H, Xu F, Yao L, Yu B, Chen L, Cai G, Xu C, Sun X, Bao Z, Chen J, Xiang Y, Zhao S. Sequential chemo-immunotherapy followed by standard versus reduced thoracic radiotherapy for older and/or frail stage III non-small-cell lung cancer: A randomized open-label cohort trial. PLoS Med. 2026 May 27;23(5):e1005111. doi: 10.1371/journal.pmed.1005111. eCollection 2026 May. PMID 42201929

Идентификаторы

NCT: NCT05557552 · 2021(189)

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗