NCT07323732招募中2 期
A Phase II Study of BIO 300 to Reduce the Toxicity of Thoracic Radiotherapy for Patients With Early-Stage Non-Small Cell Lung Cancer and Interstitial Lung Disease (BREATHE)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 8
- 主要终点
- Pneumonitis free survival
研究概览
简要总结
The purpose of this study to find out whether giving BIO 300 in combination with thoracic radiation therapy is effective in preventing pneumonitis in people with non-small cell lung cancer (NSCLC) and interstitial lung disease (ILD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. - Patient age ≥ 18 at time of consent
- •Stage I - II NSCLC (as per the American Joint Commission on Cancer (AJCC) 8th edition)
- •° Pathologically proven diagnosis of cancer is strongly recommended but is not required if the risk of biopsy is unacceptable. If pathological evidence is not available, there must be clinical evidence for NSCLC and multidisciplinary consensus for treatment.
- •Interstitial Lung Disease diagnosis (one of the below)
- •ILD as diagnosed and managed by a pulmonologist
- •ILD based on diagnostic imaging criteria and abnormal DLCO
- •ILD as a result of connective tissue diseases (e.g., polymyositis/dermatomyositis, rheumatoid arthritis, systemic lupus erythematosus, Sjogren's syndrome, scleroderma, mixed connective tissue disease)
- •ECOG performance status of 0 - 3
- •Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrhoeic for 12 months without an alternative medical cause. The following age-specific requirements apply:
- •Women <50 years of age would be considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
- •Women ≥50 years of age would be considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses >1 year ago, had chemotherapy-induced menopause with last menses >1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).
- •Life expectancy of at least 6 months
排除标准
- •Previous thoracic radiation
- •History of pneumonectomy
- •Major surgical procedure (e.g. intra-cranial, intra-thoracic, intra-abdominal, or intra-pelvic) within 28 days prior to enrollment.
- •Severe concurrent illness that may preclude timely completion of thoracic radiation or study procedures
- •Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
- •ILD exacerbation requiring hospitalization in the last 30 days
- •Poorly controlled cardiac arrhythmias not responding to medical therapy or a pacemaker
- •Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential unless they are willing to employ a highly effective non-estrogen based contraception from screening to 30 days after the last dose of BIO 300 or to abstain from sexual intercourse during these time periods.
- •Effective method of non-estrogen-based contraception: condom and a diaphragm, condom and intrauterine device, condom and Depo-Provera, condom and Nexplanon, or condom and progesterone mini-pill
- •Women who have been off estrogen contraceptives for a minimum 5 days prior to the first scheduled day of study intervention dosing are eligible.
- •Concomitant medications:
- •Any investigational anticancer therapy.
- •Planned concurrent chemotherapy or immunotherapy
- •Biologic drugs targeting the immune system (e.g. TNFα blockers, anakinra, rituximab, abatacept, tocilizumab) planned to be use concurrently with BIO 300
研究组 & 干预措施
Participants with Non-Small Cell Lung Cancer and Interstitial Lung Disease
Experimental
Participants with Non-Small Cell Lung Cancer/NCSLC and Interstitial Lung Disease/ILD
干预措施: BIO 300 (Drug)
结局指标
主要结局
Pneumonitis free survival
时间窗: Up to 36 months
The primary objective of this study is to assess the improvement in the Grade ≥ 3 pneumonitis free survival in participants with Interstitial Lung Disease/ILD treated with BIO 300 in combination with thoracic radiotherapy.
次要结局
未报告次要终点
研究者
研究点 (8)
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