Furmonertinib Combined With Local Therapy in Inoperable or Surgery-Refusing Early-Stage Non-Small Cell Lung Cancer:A Single-arm, Phase II Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- 2-year EFS rate
研究概览
简要总结
The goal of this Single-arm, Phase II clinical trial is to learn whether ablation or stereotactic radiotherapy combined with furmonertinib can treat early-stage non-small cell lung cancer in patients who are inoperable or refuse surgery.
The main purposes of this study is to answer:
Can ablation or stereotactic radiotherapy combined with furmonertinib improve survival in patients with early-stage NSCLC who are inoperable or refuse surgery? Can ablation or stereotactic radiotherapy combined with furmonertinib reduce recurrence in patients with early-stage NSCLC who are inoperable or refuse surgery?
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
- •Voluntarily participate in the clinical study
- •Aged ≥ 18 years at the time of signing the informed consent form
- •Histologically or cytologically confirmed early-stage T1-3 N0 NSCLC, or patients with multiple primary lesions or solitary pulmonary parenchymal recurrence
- •Confirmed presence of EGFR-sensitive mutations by genetic testing, including but not limited to Exon 19 deletion, L858R, G719X, L861Q, S768I, and their compound mutations
- •ECOG performance status score of 0-2
- •Deemed medically inoperable or refuse surgery after multidisciplinary evaluation
- •Pulmonary lesions suitable for ablation or radiotherapy (either modality)
- •Adequate major organ function
排除标准
- •Known severe allergic reaction (NCI-CTCAE v5.0 grade ≥ 3) to any monoclonal antibody or any excipient of the study drug
- •Known contraindications to ablation or radiotherapy
- •Failure to meet the minimum requirements for target coverage and dose constraints to organs at risk in the SABR treatment plan
- •Active infection requiring systemic anti-infective therapy within 14 days prior to the first dose
- •Patients with hepatitis B (hepatitis B surface antigen [HBsAg] positive and detectable HBV-DNA indicating viral replication); hepatitis C (hepatitis C virus [HCV] antibody positive and detectable HCV-RNA indicating viral replication)
- •Receipt of curative-intent radiotherapy within 3 months prior to the first dose
- •Major surgery within 28 days prior to the first dose (major surgery in this study is defined as any procedure requiring at least 3 weeks of recovery before the study treatment can be administered)
- •Concurrent participation in another clinical study, or receipt of intervention in any other clinical trial (including drugs and devices) within 3 months or 5 half-lives prior to screening, whichever is longer
- •Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this study
研究组 & 干预措施
Local therapy
Subjects will receive ablation or stereotactic body radiotherapy, followed by sequential treatment with furmonertinib for 3 years.
Dosing regimen: furmonertinib 80 mg once daily (QD), administered orally for 3 consecutive years.
干预措施: ablation (Procedure)
Local therapy
Subjects will receive ablation or stereotactic body radiotherapy, followed by sequential treatment with furmonertinib for 3 years.
Dosing regimen: furmonertinib 80 mg once daily (QD), administered orally for 3 consecutive years.
干预措施: stereotactic body radiotherapy (Radiation)
Local therapy
Subjects will receive ablation or stereotactic body radiotherapy, followed by sequential treatment with furmonertinib for 3 years.
Dosing regimen: furmonertinib 80 mg once daily (QD), administered orally for 3 consecutive years.
干预措施: furmonertinib (Drug)
结局指标
主要结局
2-year EFS rate
时间窗: Within two years after the treatment
defined as the proportion of patients who experience no event (including disease progression, recurrence, distant metastasis, discontinuation of treatment for any reason, or death) within 24 months from the start of treatment, relative to the total enrolled population.
次要结局
- 3-year EFS rate(Within three years after the treatment)
- overall survival(through study completion, an average of 5 year)
- Local control rate (LCR)(through study completion, an average of 1 year)
- Time to distant metastasis(through study completion, an average of 1 year)
研究者
Xuefei Hu
Chief Physician
Shanghai Pulmonary Hospital, Shanghai, China