NCT04687241进行中（未招募）3 期
Efficacy and Safety of Almonertinib Versus Placebo as Adjuvant Therapy for Subjects With Resected Stage II-IIIB NSCLC Harboring EGFR-sensitive Mutations: A Randomized, Controlled, Double-blind, Phase 3 and Multicenter Clinical Study
Jiangsu Hansoh Pharmaceutical Co., Ltd.1 个研究点 分布在 1 个国家目标入组 192 人开始时间: 2021年4月30日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- DFS (Disease free survival) assessed by IRC (Independent Review Committee)
研究概览
简要总结
To assess the efficacy and safety of Almonertinib versus placebo in patients with epidermal growth factor receptor mutation-positive (EGFRm+) stage II-IIIB non-small cell lung cancer (NSCLC), following complete tumor resection with or without adjuvant chemotherapy.
详细描述
HS-10296-302 is a randomized, placebo-controlled, double-blind, multicenter, phase III study to assess the efficacy and safety of Almonertinib versus placebo in stage II-IIIB NSCLC with EGFRm+ following complete tumor resection, with or without postoperative adjuvant chemotherapy (2~4 cycles of platinum-based doublet). Eligible patients are randomized to receive either Almonertinib (110 mg orally, once daily) or placebo (110 mg orally, once daily) in a 1:1 ratio.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Provision of informed consent before any study-specific procedures, sampling and analyses.
- •Male or female, age at least 18 years.
- •Histologically confirmed diagnosis of primary non-small lung cancer (NSCLC) on predominantly non-squamous histology.
- •MRI or CT scan of the brain must be done before surgery to exclude brain metastasis.
- •Complete surgical resection of the primary NSCLC and lymphadenectomy are mandatory. All gross disease must have been removed at the end of surgery. All surgical margins of resection must be negative for tumor.
- •Patients must be classified post-operatively as Stage IIA, IIB, IIIA or IIIB (only T3N2M0) based on pathologic criteria.
- •Confirmation by the central laboratory that the tumor harbors one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either alone or in combination with other EGFR mutations including T790M.
- •Complete recovery from surgery and standard post-operative therapy (if applicable) at the time of randomization.
- •A WHO performance status of 0-1 with no deterioration over the past 2 weeks and a minimum life expectancy of 12 weeks.
- •Female patients should be using adequate contraceptive measures and should not be breastfeeding at the screening period, during the study, and six months after the last dosing of study. A pregnancy test should be done before first dosing unless having evidence of non-child-bearing potential.
- •Male patients should be willing to use barrier contraception (condoms).
排除标准
- •Patients who have had only segmentectomies or wedge resections.
- •Treatment with any of the following:
- •Any prior anticancer therapy for the current lung cancer (pre-operative (neoadjuvant) platinum-based or other chemotherapy, pre-operative or post-operative or planned radiation therapy, neoadjuvant or adjuvant EGFR-TKI, other targeted therapy and immunotherapy).
- •Major surgery (including primary tumor surgery, excluding placement of vascular access) within 3 weeks of the first dose of study drug.
- •Patients currently receiving medications or herbal supplements known to be strong inducers and inhibitors of cytochrome P450 (CYP) 3A
- •Treatment with an investigational drug within five half-lives of the compound or any of its related material.
- •Inadequate bone marrow reserve or organ function.
- •Any of the following cardiac criteria:
- •Mean resting corrected QT interval (QTc) > 470 ms obtained from 3 electrocardiograms (ECGs), using the screening clinic's ECG machine and Fridericia's formula for QT interval correction (QTcF).
- •Any clinically important abnormalities in rhythm, conduction, or morphology of the resting ECG (e.g., PR interval > 250 ms).
- •Any factors that increase the risk of QTc prolongation or risk of arrhythmic events, such as heart failure or any concomitant medication known to prolong the QT interval.
- •Left ventricular ejection fraction (LVEF) ≤ 40%.
- •History of other malignancies, excluding full treated non-melanoma skin cancer, in-situ cancer, or other solid tumors that hadn't recurrent for > 5 years following the end of treatment.
- •Any evidence of severe or uncontrolled systemic diseases (including uncontrolled hypertension and active bleeding diatheses) or active infection (including hepatitis B, hepatitis C, and human immunodeficiency virus (HIV)).
- •Refractory nausea, vomiting, or chronic gastrointestinal diseases, or inability to swallow the study drug that would preclude adequate absorption of Almonertinib.
- •History of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD.
- •Any unresolved toxicities from prior therapy greater than CTCAE Grade 1 except alopecia and Grade 2 prior platinum-therapy related neuropathy.
- •History of hypersensitivity to any active or inactive ingredient of Almonertinib or to drugs with a similar chemical structure or class to Almonertinib.
- •Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply study procedures, restrictions, and requirements.
- •Any severe and uncontrolled ocular disease that may, in the ophthalmologist's opinion, present a specific risk to the patient's safety.
- •Any disease or condition that, in the opinion of the investigator, would compromise the safety of the patient or interfere with study assessments.
研究组 & 干预措施
Almonertinib
Experimental
干预措施: Almonertinib (Drug)
Placebo Almonertinib
Placebo Comparator
干预措施: Placebo Almonertinib (Drug)
结局指标
主要结局
DFS (Disease free survival) assessed by IRC (Independent Review Committee)
时间窗: From the time of randomization to recurrence of tumor or death, approximately 4 years.
DFS is defined as the time from randomization to the recurrence of tumor as assessed by IRC or death from any cause on study. The patients will receive long-term follow-up including chest and abdominal CT every 12 weeks during Year 1, then every 24 weeks during Years 2 to 5, and every 48 weeks during Year 6 and onwards; MRI/CT of brain, and bone scan performed every 48 weeks.
次要结局
- DFS (Disease free survival) assessed by INVs (Investigators)(From the time of randomization to recurrence of tumor or death, approximately 4 years.)
- OS rate at 5 years(The time from randomization to death due to any cause, approximately 8 years.)
- Incidence and severity of adverse events (AEs)(From the screening period to 28 days after treatment completion, approximately 4 years.)
- Plasma concentrations of Almonertinib and HAS-719 metabolite.(From Cycle 3 (Each cycle =3 weeks) to Cycle 4, approximately 3 weeks.)
- DFS rate at 2, 3 and 5 years assessed by IRC(From the time of randomization to recurrence of tumor or death, approximately 6 years.)
- OS (Overall survival)(The time from randomization to death due to any cause, approximately 8 years.)
研究者
研究点 (1)
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