NCT07153770尚未招募2 期
Bozitinib Combined With Chemotherapy as Radical Treatment for Stage IIA-IIIC MET-Altered Non-Small Cell Lung Cancer
Shanghai Pulmonary Hospital, Shanghai, China0 个研究点目标入组 34 人开始时间: 2025年9月20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
- 尚未招募
- 发起方
- 入组人数
- 34
- 主要终点
- Major Pathological Response
研究概览
简要总结
This study aim to evaluate the efficacy and safety of Bozitinib combined with chemotherapy as radical treatment for stage IIA-IIIC MET-altered non-small cell lung cancer
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
- •Patients must meet all of the following inclusion criteria to participate in this study:
- •Signed informed consent.
- •Age ≥ 18 years.
- •Histologically or cytologically confirmed NSCLC adenocarcinoma, with -postoperative pathology confirming stage IIA-IIIC.
- •Willing to undergo curative resection, and assessed by a surgeon as operable with no surgical contraindications.
- •No prior systemic anti-tumor therapy.
- •Expected survival ≥ 6 months.
- •At least one measurable or evaluable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.
- •Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-
- •MET alteration confirmed by NGS gene testing, including the following types:
- •MET exon 14 skipping mutation (NGS results from tissue or blood sample certified by CLIA or CAP).
- •MET primary amplification, NGS positive or FISH GCN ≥6 (results from tissue or blood sample certified by CLIA or CAP or FISH assay).
- •MET protein overexpression, immunohistochemistry showing ≥50% tumor cells with ++ or higher staining.
- •Adequate pulmonary function to tolerate surgery.
- •Adequate organ and bone marrow function, defined as:
- •Hematology: absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L; platelets ≥ 100 × 10⁹/L; hemoglobin ≥ 9.0 g/dL.
- •Hepatic function: total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); for patients with HCC, liver metastases, or history/suspected Gilbert syndrome (persistent or recurrent hyperbilirubinemia, mainly unconjugated, without evidence of hemolysis or liver lesions), TBIL ≤ 3 × ULN; for patients without HCC or liver metastases, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN.
- •Renal function: serum creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance (CCr) ≥ 50 mL/min; urine dipstick protein < 2+.
- •Coagulation: activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤ 1.5 × ULN.
- •Thyroid function: normal thyroid-stimulating hormone (TSH); if baseline TSH is outside the normal range, enrollment is allowed if total T3 (or FT3) and FT4 are within normal limits.
- •Cardiac enzymes: within normal range (isolated laboratory abnormalities deemed clinically insignificant by the investigator are acceptable).
- •Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 3 days prior to the first dose of study drug (Cycle 1, Day 1). If urine pregnancy test cannot be confirmed negative, a serum pregnancy test is required. Non-childbearing females are defined as postmenopausal for at least 1 year, or surgically sterile (bilateral oophorectomy or hysterectomy).
- •All subjects with potential risk of pregnancy (male or female) must use highly effective contraception with a failure rate <1% during treatment and for 120 days after the last dose of study drug (or 180 days after the last dose of chemotherapy).
排除标准
- •Patients meeting any of the following criteria are not eligible for this study:
- •Presence of EGFR, ALK, ROS1, or other actionable mutations excluding MET. Receipt of live attenuated vaccines within 4 weeks prior to enrollment or planned during the study period.
- •All participants must undergo brain imaging (MRI or contrast-enhanced CT) prior to enrollment to rule out brain metastases.
- •Major surgery (e.g., thoracic, abdominal, or pelvic) within 4 weeks prior to study treatment initiation, or ongoing recovery from surgical complications.
- •Diagnosis of any malignancy other than NSCLC within 5 years prior to study treatment initiation (excluding completely resected basal cell carcinoma or squamous cell carcinoma of the skin, in situ carcinoma, or completely resected papillary thyroid carcinoma).
- •Active, known, or suspected autoimmune disease.
- •Known history of primary immunodeficiency.
- •Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- •Known hypersensitivity to the study drug bozitinib, platinum-based doublet chemotherapy, or any excipients.
- •Not fully recovered from any toxicity and/or complications caused by prior interventions (i.e., ≤ Grade 1 or returned to baseline, excluding fatigue or alopecia) prior to study treatment.
- •Untreated active hepatitis B infection (defined as HBsAg positive with detectable HBV-DNA above the upper limit of normal at the local laboratory).
- •Note: Patients with hepatitis B meeting the following criteria may be enrolled:
- •HBV viral load <1000 copies/mL (200 IU/mL) prior to first dose; patients must receive antiviral therapy throughout chemotherapy to prevent viral reactivation.
- •Patients who are anti-HBc (+), HBsAg (-), anti-HBs (-), and HBV viral load (-) do not require prophylactic antiviral therapy but must be closely monitored for viral reactivation.
- •Active hepatitis C infection (HCV antibody positive and HCV-RNA above the assay lower limit of detection).
- •Any history, condition, treatment, or laboratory abnormality that could interfere with study results, hinder full participation, or that the investigator considers a potential risk or inappropriate for enrollment.
研究组 & 干预措施
Bozitinib group
Experimental
Participants will receive bozitinib in combination with standard platinum-based doublet chemotherapy for 8 weeks. Following investigator-assessed operability, surgical resection will be performed approximately 4 weeks after completion of neoadjuvant therapy. The first MRD assessment will be conducted after completion of neoadjuvant therapy and before surgery.A second MRD assessment will be performed within 7 days to 1 month after surgery. Based on a comprehensive evaluation of MRD status, tumor markers, and imaging results, if molecular abnormalities are detected., patients will receive bozitinib within 3 months after surgery. If CEA remains within the normal range and blood cfDNA-MRD is negative, patients will enter a regular follow-up program, with MRD assessments every 3 months during the first 2 years and every 6 months from years 3 to 5. If MRD conversion to positive, abnormal CEA, or abnormal CT findings occur within 5 within 5 years, bozitinib will be administered.
干预措施: Bozitinib (Drug)
结局指标
主要结局
Major Pathological Response
时间窗: Up to 6 month
defined as the proportion of patients who achieve a major pathological response among all patients undergoing surgical pathological assessment. Major pathological response is defined as ≤10% viable tumor cells in the resected primary tumor and regional lymph nodes, as assessed by hematoxylin and eosin (H\&E) staining.
次要结局
- Objective Response Rate(Up to 6 month)
- Pathological Complete Response rate(Up to 6 month)
- Disease Control Rate(Up to 2 year)
- Event-Free Survival(Up to 2 year)
- Overall Survival(Up to 5 year)
- 3-Year Overall Survival(Up to 3 year)
研究者
Chunxia Su
Professor
Shanghai Pulmonary Hospital, Shanghai, China
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