NCT07336732招募中2 期
An Open-label, Randomized, Multicenter Phase II/III Study to Evaluate the Efficacy and Safety of Andamertinib With or Without Platinum-doublet Chemotherapy Versus Platinum-doublet Chemotherapy in Patients With Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer Harboring Atypical EGFR Mutations Who Have Not Received Prior Systematic Therapy
Avistone Biotechnology Co., Ltd.1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年3月11日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).
研究概览
简要总结
This study is an open-label, randomized, multicenter phase II/III clinical trial designed to evaluate the efficacy, safety, and tolerability of Andamertinib with or without platinum-based chemothsrapy versus platinum-based chemotherapy in previously untreated participants with locally advanced or metastatic non-squamous NSCLC harboring EGFR atypical mutations. The study comprises two stages: phase II (dose-exploration stage) and phase III (pivotal study stage)
详细描述
This a three-stage study consist a Screening Phase (Day -28 to -1), a Treatment Phase (until treatment discontinuation), and a Follow-up Phase (including end of treatment visit (EOT),end of study visit(EOS), safety follow-up and survival follow-up).
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
- •Age ≥18 years at the time of ICF signing.
- •Histologically or cytologically confirmed, unresectable locally advanced (Stage IIIB or IIIC) or metastatic (Stage IV) non-squamous non-small cell lung cancer (NSCLC).
- •Confirmed EGFR atypical mutation.
- •No prior systemic therapy for locally advanced or metastatic NSCLC.
- •At least one measurable lesion as defined by RECIST v1.
- •Life expectancy≥12 weeks.
- •Adequate organ function confirmed within 7 days prior to the first dose of study treatment
- •Female participants must use adequate contraceptive measures during study participation and for 90 days after the last dose of study treatment and must not be breastfeeding; female subjects not of childbearing potential must meet at least one of the following criteria at screening: Postmenopausal status; Documentation of irreversible surgical sterilization.
- •Non-sterilized males: Abstinence or contraception use; No sperm donation.
- •Willing and able to provide signed ICF and to comply with all requirements and restrictions listed in the ICF and this study protocol.
排除标准
- •Presence of specific genetic alterations for which approved targeted therapies are available.
- •Recent participation (within 28 days) in another interventional clinical trial.
- •Major surgery within 28 days prior to study entry or planned during the study period.
- •Recent use of anti-tumor traditional proprietary medicine or local anti-tumor therapy.
- •Need for specific concomitant medications (e.g., metformin) that cannot be paused during the study.
- •History of another active malignancy within the past 5 years (except for specific cured cancers).
- •Toxicities from prior therapy have not recovered to acceptable levels.
- •Presence of symptomatic or uncontrolled brain metastases, carcinomatous meningitis, or spinal cord compression.
- •Symptomatic and uncontrolled third-space fluid accumulations (e.g., pleural effusion, ascites).
- •Severe cardiovascular/cerebrovascular disease or risk factors (e.g., heart failure, history of myocardial infarction, QT prolongation, uncontrolled hypertension, etc.).
- •History or presence of interstitial lung disease, or drug/radiation-related pneumonitis.
- •Active autoimmune or inflammatory diseases.
- •Active, uncontrolled infection (including HBV, HCV, HIV, syphilis, tuberculosis, etc.).
- •Gastrointestinal disorders or surgery affecting drug ingestion or absorption.
- •Active keratitis or ulcerative keratitis.
- •History of hypersensitivity to the study drug, its analogs, or chemotherapy drugs (pemetrexed/platinum agents).
- •Recent administration (within 30 days) of a live attenuated vaccine.
- •Psychiatric disorders or substance abuse potentially affecting compliance.
- •Any other condition deemed by the investigator as unsuitable for study participation.
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).
时间窗: Up to 3 years
In phase II，Incidence of Treatment-Emergent Adverse Events (TEAEs)
RP3D
时间窗: Up to 3 years
In phase II, choose the RP3D per gained safety and efficacy data
RP3D or recommended phase 3 treatment regimen
时间窗: Up to 3 years
In phase II, choose the RP3D per gained safety and efficacy data
次要结局
- Duration of Response(DOR)(up to 3 years)
- Objective Response Rate (ORR)(Up to 3 years)
- Disease Control Rate(DCR)(up to 3 years)
- Progression-Free Survival(PFS)(up to 3 years)
- 6-month Progression-Free Survival Rate(up to 3 years)
- 6-month Overall Survival Rate(up to 3 years)
- Assess the PK characteristics of Andamertinib(On cycle1of day 1and cycle3of day1, samples were collected within 2 hours prior to dosing and 4 hours post-dosing,On Day 1of Cycle 2, Cycle 5, Cycle 7, and all subsequent odd-numbered cycles collected within 2hours prior to dosing(each cycle is 21days))
研究者
研究点 (1)
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