Neoadjuvant Afatinib in Early Stage Non Small Cell Lung Cancer. (REMNANT)
Resectable EGFR Mutant NSCLC With (or Without) Afatinib as Neoadjuvant Treatment; REMNANT an Exploratory Study of the EORTC Lung Cancer Group
研究概览
详细说明
This is a multicenter, prospective, open-label, randomized, non-comparative, two-arm phase II trial aiming to evaluate afatinib treatment in pre-operative setting in patients with EGFR mutated NSCLC.
After signing of the informed consent, patients will be registered and screened for eligibility and upon confirmation of all eligibility criteria, patients will be randomized 1:1 to:
- Arm A: once daily afatinib at a dose of 40 mg for 8 weeks followed by surgery with curative intent (anatomical resection and systematic lymph node dissection).
- Arm B: immediate surgery with curative intent (anatomical resection and systematic lymph node dissection).
Response evaluation in the pre-operative arm will be performed through CT scans at baseline, 4 and 8 weeks.
The first 5 patients enrolled in arm A will be part of a safety run-in to check that afatinib treatment doesn't delay surgery.
研究类型
注册 (预期的)
阶段
- 阶段2
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
Histological or cytological diagnosis of NSCLC;
- Patients considered operable and with resectable tumor with curative intent (anatomical resection and systematic lymph node dissection) based on evaluation by a thoracic multi-disciplinary team composed of at least a thoracic surgeon, oncologist and radiologist;
- Stage I-III (T1a-3, N0-1, M0 according to UICC version 7) NSCLC by local staging criteria potentially treatable by radical (curative) surgery. Patients with T1 tumor at baseline will be limited to 20%;
- Radiologically measurable disease according to RECIST criteria 1.1; assessed by chest and upper abdomen CT scan within 2 weeks (+1 week) prior to registration); brain CT scan or MRI according to local practice;
- No prior treatment for NSCLC is allowed;
- Adequate tissue in terms of quality and quantity for EGFR local testing.
Exclusion Criteria:
- no adequate bone marrow function within 2 weeks prior to randomization
- no adequate liver function. Patients with Gilbert's syndrome total bilirubin must be below 4 times institutional upper limit of normal; within 2 weeks prior to randomization
- no adequate renal function within 2 weeks prior to randomization
- known positivity to human immunodeficiency virus (HIV), hepatitis B or hepatitis C;
- known history of allergic reactions attributed to compounds of similar chemical or biological composition;
- history of a hematologic or primary solid tumor malignancy, unless no evidence of that disease for 5 years, except pT1-2 prostatic cancer Gleason score < 6, superficial bladder cancer, non melanoma skin cancer or carcinoma in situ of the cervix;
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Neo adjuvant afatinib
once daily afatinib at a dose of 40 mg for 8 weeks followed by surgery with curative intent (anatomical resection and systematic lymph node dissection).
|
once daily afatinib at a dose of 40 mg for 8 weeks
anatomical resection and systematic lymph node dissection
|
有源比较器:Immediate surgery
immediate surgery with curative intent (anatomical resection and systematic lymph node dissection).
|
anatomical resection and systematic lymph node dissection
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Decrease in cT-stage
大体时间:8 weeks
|
decrease in cT-stage descriptor measured according to RECIST 1.1
|
8 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Response Rate
大体时间:8 weeks
|
proportion of patients whose response is either complete response (CR) or partial response (PR) using RECIST 1.1;
|
8 weeks
|
Change in surgical treatment intent and technique
大体时间:8 weeks
|
8 weeks
|
合作者和调查者
调查人员
- 首席研究员:Sanjay Popat, PhD、Royal Marsden NHS Foundation Trust
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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