NCT06644313尚未招募2 期
Vebreltinib for Neoadjuvant in MET-altered Stage IIIA-IIIB (N2) Non-small Cell Lung Cancer (NSCLC)
Shanghai Pulmonary Hospital, Shanghai, China0 个研究点目标入组 31 人开始时间: 2024年11月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 31
- 主要终点
- Objective response (ORR) rate
研究概览
简要总结
According to the 2024 edition of the NCCN guidelines and the 2023 edition of the CSCO guidelines, perioperative treatment is recommended for patients with stage IIIA and IIIB (T3N2) non-small cell lung cancer (NSCLC). Targeted therapies for NSCLC, such as EGFR inhibitors and ALK inhibitors, have been explored in the neoadjuvant setting. For patients with MET alterations, some have undergone preoperative MET inhibitor treatment, achieving pathological downstaging followed by surgery, resulting in R0 resection. Therefore, this is a prospective, cohort, single-center phase II clinical study to evaluate the efficacy and safety of Vebreltinib as a neoadjuvant treatment for patients with MET-altered stage IIIA-IIIB (N2) NSCLC.
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
- •The patient shall sign the Informed Consent Form. 2.Aged 18 ≥ years. 3.Histological or cytological diagnosis of NSCLC by needle biopsy, and evaluated by researchers as stage III-IVA.
- •4.NGS gene testing confirmed MET alterations, which include the following two types: Cohort 1: MET exon 14 skipping mutations (NGS results from tissue or blood samples certified by CLIA or CAP-approved laboratories); Cohort 2: Primary MET amplification (NGS results or FISH results from tissue or blood samples certified by CLIA or CAP-approved laboratories)..
- •5.Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or
- •According to the MDT evaluation (which should include a thoracic surgeon specializing in tumor surgery), it is considered that the primary NSCLC is potentially completely resectable;
- •At least 1 measurable lesion according to RECIST 1.
- •8.Patients with good function of other main organs (liver, kidney, blood system, etc.) 9.Patients with lung function can tolerate surgery; 10.Fertile female patients must voluntarily use effective contraceptives not less than 120 days after chemotherapy or the last dose of toripalimab (whichever is later) during the study period, and urine or serum pregnancy test results within 7 days prior to enrollment are negative.
- •Unsterilized male patients must voluntarily use effective contraception during the study period not less than 120 d
排除标准
- •Previously received targeted therapy (including TKI or monoclonal antibodies), immunotherapy, or any investigational drug treatment for NSCLC; 2.Pathological confirmation of mixed small cell and non-small cell lung cancer; 3.Patients with a malignancy other than NSCLC within five years prior to the start of this trial，except for cured basal cell carcinoma of the skin, early gastrointestinal (GI) carcinoma excised through endoscopy, cervical carcinoma in situ, ductal carcinoma in situ of the breast, papillary thyroid carcinoma, or any cured cancer deemed to have no impact on the survival of the current NSCLC; 4.Participants with any unstable systemic disease (including active infection, uncontrolled hypertension), unstable angina pectoris, angina pectoris starting in the last three months, congestive heart failure (>= NYHA) Grade II), myocardial infarction (6 months before admission), severe arrhythmia requiring drug treatment, liver, kidney or metabolic diseases; 5.Patients with congenital or acquired immune dysfunction (such as HIV infected individuals); 6.Received other major surgical treatments (excluding diagnosis) within 4 weeks prior to the start of the study or expected to undergo major surgical treatments during the study period; 7.Participants who are allergic to the test drug or any auxiliary materials; 8.A history of extensive diffuse bilateral interstitial fibrosis in the past or before medication, or a known grade 3 or 4 history of interstitial fibrosis or interstitial lung disease, including pneumonia, allergic pneumonia, interstitial pneumonia, interstitial lung disease, obliterative bronchiolitis, and pulmonary fibrosis, but not including local radiation pneumonia or radiation pulmonary fibrosis history;
- •Pregnant or lactating women; 9.Any malabsorption; 10.Participants suffering from nervous system diseases or mental diseases that cannot cooperate 11.Other factors that researchers think it is not suitable for enrollment.
研究组 & 干预措施
Vebreltinib
Experimental
干预措施: Vebreltinib (Drug)
结局指标
主要结局
Objective response (ORR) rate
时间窗: up to 30 months
ORR is defined according to the RECIST v1.1 criteria.
次要结局
- Disease control rate (DCR)(up to 30 months)
- Major pathologic response (MPR) rate(Up to 30 months)
- Pathologic complete response (PCR) rate(Up to 30 months)
- Event-free survival (EFS)(up to 60 months)
- 3-year overall survival (OS)(Up to 36 months)
- Overall survival (OS)(up to 60 months)
- Treatment-related adverse event (TRAE)(Up to 30 months)
研究者
Peng Zhang
Director of thoracic department
Shanghai Pulmonary Hospital, Shanghai, China
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