KCT0009074尚未招募Unknown
azertinib and Tepotinib for EGFR mutant NSCLC in MET overexpressed or amplified who progressed after Lazertinib treatment: A phase II multi-center trial
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 47
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1.Histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer which is not amenable to treatment with a curative aim (e.g., surgery or radiation)
- •2.Confirmed EGFR mutations (exon 19 deletion, L858R) with acquired resistance after first-line lazertinib treatment (either partial response, complete response or stable disease last more than 6 months after initiation of Lazertinib) - patient can maintain the treatment with prior EGFR treatment as beyond progression until the patient start the treatment per this protocol
- •3.First-line cytotoxic chemotherapy received as palliative treatment is acceptable after the failure of Lazertinib (Patients with disease progression after adjuvant or neoadjuvant chemotherapy within 6 months are eligible to participate)
- •4.Patient with MET amplification FISH GCN =5 and/or MET/CEP7 = 2 (If additional resistance mechanism to lazertinib, such as C797S, is observed with MET amplification, the recruitment needs to be discussed in advance with the principal investigator)
- •5.Available tissue for MET FISH
- •6.Age of 19 or more
- •7.Performance status of Eastern Cooperative Oncology Group 0 to 2
- •8.Expected minimum life expectancy of 12 weeks
- •9.Adequate organ function
- •a.Absolute neutrophil count (ANC) =1500cells/mm3
- •b.Platelet count =100,000cells/mm3
- •c.Total bilirubin =1.5 x upper limit of normal(ULN)
- •d.Aspartate transaminase (AST) and alanine transaminase (ALT) = 2.5 x ULN (or =5.0 x ULN, if liver metastasis is present)
- •e.Creatinine level =1.5 x upper limit of normal (ULN) or creatinine clearance = 45mL/min (Calculated with Cockcroft- Gault equation)
- •10.Available to provide the adequate tissue and blood for the genomic tests
- •- At least 20 unstained slide and 20 cc of blood at baseline and disease progression (If not, participant must be confirmed by the principal investigator
- •11.Agreed to perform re-biopsy at the timepoint of disease progression
- •12.Female subjects must either be of non-reproductive potential
- •13.Subject willing and able to comply with the protocol
- •14.Signed written informed consent
排除标准
- •1) Previously treatment with any kind of EGFR TKI other than lazertinib
- •2) All concurrent and/or other active malignant tumors requiring systemic therapy within 2
- •years prior to the initial administration of the investigational drug (However, the patient
- •may participate if previous malignant tumor has been cured, and no further treatment is
- •3) Uncontrolled central nervous system metastases
- •4) Spinal cord compression, leptomeningeal carcinomatosis
- •5) Uncontrolled systemic illness, including uncontrolled hypertension, active bleeding, or
- •active infection
- •6) Radiotherapy with a wide field of radiation within 2 weeks or radiotherapy with a limited
- •field of radiation (localized radiotherapy or gamma knife surgery) for palliation within 1
- •7) Any unresolved toxicities from prior therapy, greater than CTCAE grade 1
- •8) Prior history of interstitial lung disease (ILD) or ILD like symptoms
- •9) Mean QT interval corrected for heart rate (QTc) = 470 ms
- •10) No measurable lesion
- •11) Unable to swallow the product due to refractory nausea, vomiting or chronic
- •gastrointestinal disease
- •12) Significant cardiovascular disease, such as New York Heart Association cardiac disease
- •(Class II or greater), myocardial infarction, or cerebrovascular accident within 3 months
- •prior to randomization, unstable arrhythmias, or unstable angina
- •Patients with known coronary artery disease, congestive heart failure not meeting the
- •above criteria, or left ventricular ejection fraction < 50% must be on a stable medical
- •regimen that is optimized in the opinion of the treating physician, in consultation with a
- •cardiologist if appropriate.
- •13) Pregnant or breastfeeding women
研究者
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