NCT07274761进行中（未招募）2 期
A Phase II, Single-arm, Single-center Study of Neoadjuvant Sunvozertinib for Stage II-IIIB Non-small Cell Lung Cancer With EGFR Exon 20 Insertion Mutations.
Shanghai Pulmonary Hospital, Shanghai, China1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2024年10月17日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
To assess the efficacy and safety of sunvozertinib as neoadjuvant therapy in patients with stage II-IIIB non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •1. The patient must understand the trial requirements and contents, and provide written informed consent.
- •2.Age ≥ 18 years. 3.Histologically or cytologically confirmed non-squamous non-small cell lung cancer (NSCLC). Assessed as resectable Stage II-III disease (per the American Joint Committee on Cancer (AJCC) 8th edition).
- •4.Confirmed EGFR exon 20 insertion mutation by a validated test. 5.No evidence of disease progression within the past two weeks prior to signing informed consent and an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •6.Adequate hematological and organ function, as defined by: 7.Hematological: Absolute Neutrophil Count (ANC) ≥ 1.5 × 10^9/L Platelet count ≥ 100 × 10^9/L Hemoglobin ≥ 9 g/dL
- •Total bilirubin ≤ 1.5 × Upper Limit of Normal (ULN); for patients with Gilbert's syndrome (unconjugated hyperbilirubinemia) or liver metastases, total bilirubin ≤ 3 × ULN.
- •Alanine Aminotransferase (ALT) ≤ 2.5 × ULN and Aspartate Aminotransferase (AST) ≤ 2.5 × ULN in the absence of liver metastases; or ALT and AST ≤ 5 × ULN for patients with liver metastases.
- •Serum creatinine ≤ 1.5 × ULN, AND Calculated or measured creatinine clearance ≥ 60 mL/min (using the Cockcroft-Gault formula).
- •8.Male patients with female partners of childbearing potential must agree to use a highly effective barrier method of contraception (e.g., condom) during the trial intervention period and for 6 months after the last dose. Male patients must refrain from donating sperm during this same period.
- •9.Female patients must agree to use contraception from the time of screening until 6 weeks after the last dose, must not be breastfeeding, and must have a negative pregnancy test (serum or urine beta-human chorionic gonadotropin, β-hCG) at screening.
排除标准
- •1.Prior systemic anti-tumor therapy, including chemotherapy, targeted therapy, immunotherapy, and investigational agents from other clinical trials.
- •2.History of other malignancies within the past 2 years (except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix).
- •3.History of stroke or intracranial hemorrhage within 6 months prior to the first dose.
- •4.Severe or uncontrolled systemic diseases/active infection. 5.Any severe or poorly controlled systemic disease, in the investigator's judgment, including but not limited to the following cardiac conditions or abnormalities: QT interval corrected using Fridericia's formula (QTcF) > 470 msec at rest on electrocardiogram (ECG).
- •Any clinically significant abnormalities in cardiac rhythm, conduction, or morphology at rest on ECG, such as complete left bundle branch block, third-degree atrioventricular block, second-degree atrioventricular block, PR interval > 250 msec.
- •Any factors that increase the risk of QTc prolongation or arrhythmic events, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death in a first-degree relative under 40 years of age, or any other known condition associated with prolonged QT interval.
- •Presence of atrial fibrillation (except for drug-induced atrial fibrillation which has resolved after discontinuation of the causative agent).
- •Myocardial infarction ≤ 6 months prior to the first dose, New York Heart Association (NYHA) Class II or higher congestive heart failure, or poorly controlled arrhythmia despite medical treatment.
- •6.History of interstitial lung disease (ILD), drug-induced ILD, or any evidence of ILD on imaging at screening.
- •7.Refractory nausea and vomiting, chronic gastrointestinal diseases, or significant bowel resection that would preclude adequate absorption of Sunvozertinib.
- •8.Women who are breastfeeding or pregnant. 9.Known hypersensitivity to the active ingredient or any excipients of Sunvozertinib.
- •10.Patients who, in the judgment of the investigator, are unsuitable for participation in this clinical trial or are unlikely to comply with the study procedures and requirements.
研究组 & 干预措施
Sunvozertinib 300 mg orally, once daily
Experimental
干预措施: Sunvozertinib (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: up to 30 months
ORR is defined according to the RECIST v1.1 criteria.
次要结局
- Event-free suvival (EFS)(Up to 60 months)
- Overall suvival (OS)(Up to 60 months)
- Major pathologic response (MPR) rate(Up to 30 months)
- R0 resection rate(Up to 30 months)
- Pathological complete response (pCR) rate(Up to 30 months)
- N2 downstaging rate after neoadjuvant treatment(Up to 30 months)
- Treatment-related adverse event (TRAE)(Up to 30 months)
- Incidence of treatment discontinuation due to AE/SAE(Up to 30 months)
研究者
Peng Zhang
Professor
Shanghai Pulmonary Hospital, Shanghai, China
研究点 (1)
Loading locations...
相似试验
招募中
2 期
A multicenter phase II study of neoadjuvant sacituzumab govitecan plus zimberelimab followed by adjuvant zimberelimab with or without sacituzumab govitecan in patients with resectable non-small cell lung cancer (NeoTRACE)non-small cell lung cancer2024-517561-16-00AIO-Studien gGmbH50
招募中
不适用
Real-world Efficacy and Safety of Neoadjuvant Dostarlimab in Patients With dMMR/MSI-H Locally Advanced Rectal CancerNCT07269249National Cancer Institute, Naples50
招募中
2 期
Tuvonralimab and Iparomlimab Based Regimens for the Neoadjuvant Treatment of Biliary Tract CancerNCT07267078Peking Union Medical College Hospital45
招募中
3 期
A Study Evaluating the Efficacy and Safety of Neoadjuvant Treatment with Atezolizumab or Placebo in Combination with Platinum-Based Chemotherapy in Patients with Resectable Stage II, IIIA, or Select IIIB Non-small cell lung cancer2023-504209-35-00F. Hoffmann-La Roche AG207
招募中
2 期
Prospective, randomized, neoadjuvant phase II study with combination immuno-oncology in primary clear cell renal cell cancer at risk for recurrence or distant metastases (NESCIO-trial; M21NSC; CA209-6DJ)2024-515514-40-00Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting69