A Pilot Window of Opportunity Study Evaluating Durvalumab (MEDI4736) in Combination With Platinum Doublet Chemotherapy Followed by Evaluation of Durvalumab (MEDI4736) in Combination With Platinum Doublet Chemotherapy and Abequolixron (RGX-104) in Non-small Cell Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Feasibility of surgery
研究概览
简要总结
Non-Small Cell Lung Cancer (NSCLC) is one of the deadliest types of cancer. In lung cancer patients with a tumor that can be removed by surgery, adjuvant chemotherapy increases survival. Neoadjuvant therapy may have advantages such as, it may be more tolerable prior to surgery, earlier treatment may be more efficacious, and it can provide an indication of treatment response. Neoadjuvant treatment can provide pre- and post-treatment specimens for correlative analysis to better understand mechanisms of action and resistance.
This pilot study will investigate the effects of neoadjuvant durvalumab plus platinum doublet chemotherapy and neoadjuvant durvalumab plus platinum doublet chemotherapy in combination with abequolixron (RGX-104), an LXR/ApoE agonist, in subjects with NSCLC who are scheduled to undergo surgical resection as part of their standard of care.
The purpose of this study is to study how well using a combination of durvalumab, platinum doublet chemotherapy (carboplatin/abraxane or carboplatin/pemetrexed), and abequolixron treats non-small cell lung cancer before surgery. Durvalumab (a type of immunotherapy) and platinum doublet chemotherapy are drugs that are individually approved for use during the treatment of cancer. FDA (Food and Drug Administration) has not approved the combined use of these drugs in treating non-small cell lung cancer. Abequolixron is not FDA approved for the treatment of cancer.
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
- •Willing and able to provide written informed consent obtained to participate in the study and
- •HIPAA authorization for the release of personal health information.
- •Age ≥ 18 years at the time of consent.
- •Histologically or cytologically confirmed non-small cell lung cancer for which surgical resection
- •would be standard of care.
- •ECOG Performance Status of 0-1
- •Body weight of > 40 kg
- •Is able to swallow and retain oral medication.
排除标准
- •Participation in another clinical study with an investigational product during the last 3 weeks
- •Concurrent enrollment in another clinical study unless it is an observational (non-interventional)
- •clinical study or during the follow-up period of an interventional study.
- •Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment with the
- •exception of those mentioned in this protocol. Concurrent use of hormonal therapy for noncancer-
- •related conditions (e.g., hormone replacement therapy) is acceptable.
- •Lack of full recovery from a major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP.
- •History of allogenic organ transplantation.
研究组 & 干预措施
Neoadjuvant therapy
Subjects with operable Non-Small Cell Lung Cancer received neoadjuvant durvalumab plus platinum doublet chemotherapy and neoadjuvant durvalumab plus platinum doublet chemotherapy in combination with abequolixron (RGX-104), an LXR/ApoE agonist.
干预措施: Durvalumab (Drug)
Neoadjuvant therapy
Subjects with operable Non-Small Cell Lung Cancer received neoadjuvant durvalumab plus platinum doublet chemotherapy and neoadjuvant durvalumab plus platinum doublet chemotherapy in combination with abequolixron (RGX-104), an LXR/ApoE agonist.
干预措施: Carboplatin (Drug)
Neoadjuvant therapy
Subjects with operable Non-Small Cell Lung Cancer received neoadjuvant durvalumab plus platinum doublet chemotherapy and neoadjuvant durvalumab plus platinum doublet chemotherapy in combination with abequolixron (RGX-104), an LXR/ApoE agonist.
干预措施: Abequolixron (Drug)
Neoadjuvant therapy
Subjects with operable Non-Small Cell Lung Cancer received neoadjuvant durvalumab plus platinum doublet chemotherapy and neoadjuvant durvalumab plus platinum doublet chemotherapy in combination with abequolixron (RGX-104), an LXR/ApoE agonist.
干预措施: Abraxane (Drug)
Neoadjuvant therapy
Subjects with operable Non-Small Cell Lung Cancer received neoadjuvant durvalumab plus platinum doublet chemotherapy and neoadjuvant durvalumab plus platinum doublet chemotherapy in combination with abequolixron (RGX-104), an LXR/ApoE agonist.
干预措施: Pemetrexed (Drug)
结局指标
主要结局
Feasibility of surgery
时间窗: Up to 120 days
Feasibility will be evaluated as the delay time between the completion of neoadjuvant therapy and surgery. A failure of feasibility will be defined as a delay in the planned surgery of more than 42 days (surgical delay of 35 days, plus 7 days for scheduling).
次要结局
- Major pathologic response rate - non squamous histology(Up to 120 days)
- Pathologic complete response rate (PCR) -durvalumab in combination with platinum doublet chemotherapy(Up to 120 days)
- Clinical response rate (CRR) - durvalumab in combination with platinum doublet chemotherapy(Up to 1 years after surgery)
- Major pathologic response rate - squamous histology(Up to 120 days)
- Recurrence-free survival (RFS) - durvalumab in combination with platinum doublet chemotherapy(Up to 5 years)
- Recurrence-free survival (RFS)- durvalumab in combination with platinum doublet chemotherapy plus abequolixron(Up to 5 years)
- Toxicities(Up to 1 years after surgery)
- Overall Survival (OS) - durvalumab in combination with platinum doublet chemotherapy plus abequolixron(Up to 5 years)
- Pathologic complete response rate (PCR) - durvalumab in combination with platinum doublet chemotherapy plus abequolixron(Up to 120 days)
- Clinical response rate (CRR) - durvalumab in combination with platinum doublet chemotherapy plus abequolixron(Up to 1 years after surgery)
- Overall Survival (OS) - durvalumab(Up to 5 years)