Repositioning Immunotherapy in VetArans With Lung Cancer

Официальное название

Repositioning Immunotherapy in Veterans With Lung Cancer

Обзор

This study is a multicenter Phase II single arm trial to assess the safety and efficacy of chemotherapy and immunotherapy followed by radiotherapy in patients with unresectable Stage III NSCLC.

Вмешательства

• Препарат Nivolumab
  Carboplatin, paclitaxel, and nivolumab for three cycles (for squamous cell lung cancer) or Carboplatin, pemetrexed, and nivolumab for three cycles (for lung adenocarcinoma) Followed by radiotherapy (60 Gy in 30 fractions) Followed by adjuvant nivolumab (six cycles)

Первичные конечные точки

• Progression-free survival [Срок оценки: Approximately two years after enrollment]
• Treatment Tolerance [Срок оценки: Approximately three years after enrollment]

Вторичные конечные точки (3)

• Adverse Events [Срок оценки: Approximately two years after enrollment]
• Best overall response rate (BOR) [Срок оценки: Approximately two years after enrollment]
• Overall survival [Срок оценки: Approximately two years after enrollment]

Критерии участия

Критерии включения

• Patient must have a performance status of 0-1 (ECOG Performance Scale)
• Patient must be a candidate for concurrent chemoradiation
• Unresectable Stage III NSCLC as assessed by investigator or multidisciplinary tumor board assessment
• PD-L1 tumor expression greater than or equal to 1%
• Presence of measurable disease according to RECIST v1.1
• Adequate organ function
• Available tissue (archival FFPE preferred) with adequate tumor content ( 20% tumor cellularity)

Критерии исключения

• Active autoimmune disease that has requires immunosuppressive therapy in the previous year
• Uncontrolled primary or acquired immunodeficiency (including HIV)
• Baseline corticosteroid usage (>10 mg prednisone or equivalent daily) aside from supportive medication use
• Tumor with known EGFR, ALK, ROS1, MET or RET mutations/fusions
• Presence of significant comorbidities precluding participation in a clinical study as determined by investigator
• Prior thoracic radiotherapy or prior systemic treatment for stage IIIB/IV NSCLC
• Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
• Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with informed consent through 180 days after the last dose of trial treatment
• Has a known history of active TB (Bacillus Tuberculosis)
• Has known active Hepatitis B or Hepatitis C
• Has received a live vaccine within 30 days of enrollment
• Known diagnosis of Interstitial Lung Disease
• Inability to provide informed consent

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

США · 7 центров

• VA Connecticut Healthcare System West Haven Campus, West Haven, CT — West Haven
• VA Central Office, Washington, DC — Washington D.C.
• Richard L. Roudebush VA Medical Center, Indianapolis, IN — Indianapolis
• VA Ann Arbor Healthcare System, Ann Arbor, MI — Ann Arbor
• Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE — Omaha
• Michael E. DeBakey VA Medical Center, Houston, TX — Houston
• Richmond VA Medical Center, Richmond, VA — Richmond

Идентификаторы

NCT: NCT06275360 · SPLP-002-23F

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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