NCT05548348招募中2 期
A Single Arm, Multicenter Study of First-line Furmonertinib Treatment in Patients With Advanced Epidermal Growth Factor Receptor Uncommon Mutation Positive Non-small Cell Lung Cancer
Chongqing University Cancer Hospital3 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年9月26日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
Furmonertinib, a newly-designed pan-EGFR-TKI with a trifluoroethoxypyridine-based molecule structure, has shown promising clinical efficacy in EGFR Ex19del/L858R/T790M/Ex20ins mutant advanced NSCLC with an acceptable safety profile without new signals from 80mg to 240mg dose level in phase 1-3 clinical trials. Whether EGFR G719X/S768I/L861Q mutation positive advanced NSCLC patients can benefit from first-line furmonertinib 160mg per day has not been reported. This study aims to investigate the efficacy and safety of furmonertinib 160mg per day in EGFR G719X/S768I/L861Q mutant patients under first-line treatment of advanced NSCLC setting.
详细描述
This is a single arm, multicenter study which will recruit about 30 patients in China.
The study is designed to evaluate the efficacy and safety of furmonertinib in the first-line treatment of patients with EGFR G719X/S768I/L861Q mutations in advanced NSCLC.
Furmonertinib will be administered orally at a dose of 160 mg per time, Q.D.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provide informed consent prior to any study specific procedures;
- •18 -70 years of age;
- •ECOG PS of 0 to 1 at screening with no clinically significant deterioration in the previous 2 weeks, life expectancy ≥12 weeks;
- •Pathologically confirmed Non-Small Cell Lung Cancer (NSCLC);
- •Locally advanced or metastatic NSCLC not amenable to curative surgery or radiotherapy (stage IIIB-IV, according to the 8th edition of the AJCC staging system);
- •Patient with EGFR G719X or S768I or L861Q mutation diagnosed histologically or cytologically, the reports must be issued or recognized by Tier 3A hospitals. The mutations above may exist alone or together;
- •No previous systemic anti-tumor therapy for locally advanced or metastatic NSCLC;
- •According to RECIST 1.1, patients have at least one tumor lesion at baseline that meets the following requirements: accurately and repeatably measurable at baseline have no radiotherapy or biopsy;
- •For premenopausal women with childbearing potential, a pregnancy test must be performed within 14 days before the first dose, and the pregnancy test (blood or urine test) must be negative; female subjects must not be lactating;
- •Willing to use contraception (male patients); Voluntary and agree to follow the study treatment protocol as well as follow-up plan, and can accept the oral medicine treatment.
排除标准
- •small cell lung carcinoma;
- •History of hypersensitivity to active or inactive excipients of investigational product (IP) or drugs with a similar chemical structure or class to investigational product (IP);
- •Confirmed EGFR Ex20ins or Ex19del or L858R or T790M mutant;
- •Patient who receive prior treatment including: any Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI); the patients who have received intrapleural perfusion therapy can only be enrolled 28 days or more after the pleural effusion is stable; major surgery within 4 weeks of the first dose of investigational product (IP); radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of IP; CYP3A4 strong inhibitor or strong inducer is used within 7 days prior to the first dose, or need to receive these drugs during the study period; traditional Chinese medicine and traditional Chinese medicine preparations with anti-tumor as indications and with adjuvant treatment of tumor is used within 7 days prior to the first dose, or need to receive these drugs during the study period; patients who are receiving drugs known to prolong QTc interval or may cause torsade de pointe and need to continue to receive these drugs during the study period; the time from the treatment with any other investigational product or its analogue to the first dose does not exceed 5 half-lives of the drug or 14 days, whichever is longer.
- •Prior treatment with any systemic anti-cancer therapy for advanced Non-Small Cell Lung Cancer (NSCLC) including chemotherapy, biologic therapy, target therapy, immunotherapy, or any investigational drug, except neoadjuvant or adjuvant therapy before 6 months prior to the first dose IP;
- •At the beginning of study treatment, any unresolved toxic reaction to prior treatment is present, which exceeds Grade 1 in accordance with Common Terminology Criteria for Adverse Events (CTCAE) (except for alopecia), and exceeds Grade 2 for prior platinum treatment-related neuropathy;
- •Spinal cord compression; symptomatic and unstable brain metastases, except for those patients who have completed definitive therapy, are not on steroids, and have a stable neurological status for at least 2 weeks after completion of the definitive therapy and steroids.
- •Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of IP;
- •Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diatheses, and active infection, which in the Investigator's opinion makes it undesirable for the patient to participate in the trial;
- •Past medical history of Interstitial Lung Disease (ILD), drug-induced Interstitial Lung Disease, radiation pneumonitis that required steroid treatment, or any evidence of clinically active Interstitial Lung Disease;
- •Any evidence of corneal injury;
- •Inadequate bone marrow reserve or organ function;
- •QT prolongation or any clinically important abnormalities in rhythm and heart function;
- •Pregnancy or lactation;
- •Patients who may have poor compliance with the research procedures and requirements, etc., as judged by investigators.
研究组 & 干预措施
Furmonertinib treatment
Experimental
Furmonertinib will be administered orally at a dose of 160 mg per time, Q.D.
干预措施: Furmonertinib 160 mg, Q.D. (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: Approximately 12 months from the first patient begin study treatment
Objective Response Rate (ORR) (per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) using Investigator assessments) is defined as the number (%) of patients with response of Complete Response or Partial Response. Data obtained up until progression, or the last evaluable assessment in the absence of progression, will be included in the assessment of Objective Response Rate.
次要结局
- Progression-free survival (PFS)(Approximately 24 months after the first patient begin study treatment.)
- Disease Control Rate (DCR) by Investigator(Approximately 12 months from the first patient begin study treatment)
- Duration of Response (DoR)(Duration of Response analysis will occur when Progression-free survival (PFS) maturity is observed at approximately 24 months from the first patient begin study treatment)
- Overall Survival (OS)(The analysis of OS will be conducted at 2 time points: when PFS maturity is observed at approximately 24 months after the first patient begin study treatment, and when OS maturity is observed at approximately 36 months after the first patient begin study)
- Adverse Events(From the start of study drug to 30 days after the last dose of study drug)
研究者
研究点 (3)
Loading locations...
相似试验
已完成
2 期
Furmonertinib in EGFR-Mutant NSCLC With Brain Metastases (iFORCE)FurmonertinibEGFR-mutationBrain MetastasesNSCLCNCT05465343Peking Union Medical College24
招募中
2 期
Almonertinib as First-line Treatment in Patients With EGFR+ Positive Pulmonary Adenosquamous Carcinoma or Combined Adenocarcinoma and Squamous Cell CarcinomaPulmonary Adenosquamous CarcinomaNCT04354961Fujian Cancer Hospital13
进行中（未招募）
2 期
Neoadjuvant Furmonertinib and Cisplatin/Pemetrexed as in EGFR Mutated Stage IIA-IIIB Resectable NSCLC (FORESEE)Non-small Cell Lung CancerNCT05430802Tang-Du Hospital40
招募中
2 期
Efficacy and Safety of Furmonertinib in EGFR-Mutant, PD-L1+ Patients With Locally Advanced or Metastatic NSCLC (FUTURE)Non-Small-Cell Lung CancerNCT05255406Fudan University62
撤回
2 期
Aumolertinib in EGFR-Mutant Resected Stage IB-IIIA NSCLC (AERESA).Lung CancerNCT06227897Sun Yat-sen University85