Phase II Pilot Study of Quick Start Durvalumab Following Chemoradiation for Stage III Nonsmall Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Number of Participants to Achieve Fidelity to Early Treatment with Durvalumab - Early Initiation (1-14 days)
研究概览
简要总结
This research study aims to determine what effects (good and bad) Durvalumab has on participants and their cancer with a "quick start" of Durvalumab within 14 days of finishing chemotherapy and radiation. The study will also determine the logistic barriers to the quick start of Durvalumab.
详细描述
Primary Objective: Assess the treatment fidelity for early Durvalumab initiation (i.e., within 14 days after the last day of radiation therapy) following chemoradiation for unresectable Stage II or Stage III nonsmall cell lung cancer.
Secondary Objectives:
- Assess the treatment fidelity for very early Durvalumab initiation (i.e., within seven days after the last day of radiation therapy) following chemoradiation for unresectable Stage II or Stage III nonsmall cell lung cancer.
- Assess barriers to earlier Durvalumab initiation following chemoradiation for unresectable Stage II or Stage III nonsmall cell lung cancer.
- Describe the toxicity of Durvalumab when initiated quickly after chemoradiation for unresectable Stage II or Stage III nonsmall cell lung cancer as compared to historical controls.
- Describe the efficacy of Durvalumab when initiated quickly after chemoradiation for unresectable Stage II or Stage III nonsmall cell lung cancer as compared to historical controls.
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
- •Patients must have stage II or stage III NSCLC confirmed by histologic or cytologic documentation and by clinical assessment. Staging is defined according to the AJCC Cancer Staging Manual, 8th Edition (2017).
- •Unresectable or medically inoperable as determined by the investigator.
- •The patient has definitive radiation therapy (e.g., 54 Gy to 66 Gy in 30 to 35 fractions) for lung cancer that is either (a) planned to start within the next 28 days, or (b) currently being administered, or (c) has been completed within the last 14 days.
- •Platinum-based chemotherapy for lung cancer that is either (a) planned to start within the next 28 days, (b) currently being administered, or (c) has been completed within the last 14 days. Chemotherapy must be for at least two cycles and be administered either before radiation therapy ("induction" or "sequential") or during radiation therapy ("concurrent").
- •Consolidation durvalumab is planned for NSCLC after radiation and chemotherapy.
- •Eighteen years old or greater.
- •ECOG performance status of 0-
- •Life expectancy of greater than three months.
- •Patients with sexual relationships in which either they or their partner may become pregnant must use contraception during the study treatment period.
- •Ability to understand and be willing to sign an IRB-approved informed consent document directly or via a legally authorized representative.
排除标准
- •Uncontrolled respiratory symptoms (i.e., cough, dyspnea, fevers, chest pain, or an increase from baseline oxygen requirements) that are interfering with activities of daily living.
- •Nonsmall cell lung cancer is known to have a tumor with a mutation in EGFR associated with sensitivity to first-line therapy with a tyrosine kinase inhibitor (i.e., Ex19del or L858R). Testing for EGFR mutation must have been attempted for study enrollment. If EGFR testing is inconclusive (e.g., the biopsy's quantity or quality is not sufficient for testing to be performed) and there is low clinical suspicion for the presence of an EGFR mutation as determined by the investigator, then the patient is eligible.
- •Prior exposure to an immune checkpoint inhibitor targeting CTLA-4, PD-1, or PD-L
- •Active autoimmune disease requiring systemic immunosuppression at the time of enrollment.
- •History of autoimmune pneumonitis requiring high-dose systemic steroids (equivalent prednisone >20 mg/day for more than one week).
- •Uncontrolled intercurrent illness includes ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Patients who are pregnant or breastfeeding.
研究组 & 干预措施
Quick Start Durvalumab
Standard of care test and procedures for cancer treatments along with Durvalumab treatment at physician's discretion
干预措施: Durvalumab (Drug)
Quick Start Durvalumab
Standard of care test and procedures for cancer treatments along with Durvalumab treatment at physician's discretion
干预措施: the EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30) (Other)
Quick Start Durvalumab
Standard of care test and procedures for cancer treatments along with Durvalumab treatment at physician's discretion
干预措施: COPD Assessment Test (CAT) (Diagnostic Test)
Quick Start Durvalumab
Standard of care test and procedures for cancer treatments along with Durvalumab treatment at physician's discretion
干预措施: Modified Medical Research Council (mMRC) dyspnea scale (Diagnostic Test)
结局指标
主要结局
Number of Participants to Achieve Fidelity to Early Treatment with Durvalumab - Early Initiation (1-14 days)
时间窗: 48 weeks
Fidelity is defined as a dichotomous composite indicator (yes/no) that describes whether the patient received very early (1-7 days) or early (days 8-14 days) initiation of Durvalumab as per protocol with all four of the following criteria having been met: (i) CT chest obtained after the last day of radiation therapy and before the first infusion of Durvalumab, (ii) first infusion within 14 days of completing radiation therapy, (iii) second and third doses received within 63 days of the first dose, and (iv) all infusions at least 28 days apart.
次要结局
- Overall Survival(One year)
- Number of Participants to Achieve Fidelity to Early Treatment with Durvalumab - Very Early (1-7 days)(Up to 13 months)
- Progression-Free Survival(One year)
- Response Rate(One year)
- Number of Barriers to Initiation of Durvalumab - Very Early (Days 1-7)(Up to 13 months)
- Number of Barriers to Initiation of Durvalumab - Early (Days 8-14)(Up to 13 months)
- Number of Participants to Discontinue Durvalumab Due to Adverse Events(One year)
- Number of Participants with All Adverse Events(Within 85 days of intervention (Cycles 1-3))
- Number of Participants Who Have Immune-Mediated Pneumonitis(Within 85 days of intervention (Cycles 1-3))
- Number of Participants Who Have All-Cause Any Grade Pneumonitis(Within 85 days of intervention (Cycles 1-3))