ACTRN12621000811808进行中（未招募）2 期
A single arm, open label, signal-seeking, phase II trial of tepotinib in patients with advanced non-small cell lung cancer harbouring MET exon 14 skipping mutations detected by comprehensive genomic profiling
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 8
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Adults, aged 18 years and older, with newly diagnosed metastatic non-squamous NSCLC;
- •2. METex14 skipping mutation identified using CGP;
- •3. Confirmation of molecular eligibility by the molecular tumour board;
- •4. Measurable disease as assessed by RECIST 1.1; In the event of evaluable but non-measurable disease, eligibility must be confirmed by the ASPiRATION study chair or delegate through contacting the NHMRC CTC;
- •5. ECOG 0 to 2;
- •6. Adequate organ system function as assessed by the following minimal laboratory requirements (within 7 days prior to first administration of study drug):
- •a. bone marrow function; platelets greater than or equal to 100 x 10^9/L, ANC greater than or equal to 1.5 x 10^9/L, and haemoglobin greater than or equal to 90g/L (5.6mmol/L);
- •b. liver function; ALT/AST less than or equal to 3xULN (in the absence of liver metastases, less than or equal to 5xULN for patients with liver involvement) and total bilirubin less than or equal to 1.5xULN;
- •c. renal function; serum creatinine less than or equal to 1.5xULN;
- •7. Life expectancy greater than or equal to 12 weeks;
- •8. Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments;
- •9. Signed, written informed consent to participation in the specific treatment substudy.
排除标准
- •1. Prior systemic therapy for advanced disease. Up to two cycles of systemic therapy (excluding prior MET inhibitor treatment) while awaiting the results of CGP testing are permitted.
- •2. Prior MET/HGF pathway inhibitor treatment;
- •3. Known history of hypersensitivity or contraindication to tepotinib;
- •4. Specific comorbidities or conditions (e.g. psychiatric) or concomitant medications which may interact with tepotinib, including:
- •a. Known history of interstitial lung disease or drug-induced pneumonitis requiring steroid treatment
- •b. Congenital QT syndrome or baseline QTc >500ms
- •5. Active CNS involvement. Patients with stable neurological function, on stable anticonvulsants and/or steroids less than or equal to 10 mg prednisone equivalent over 4 weeks are eligible;
- •6. Co-morbidities or conditions that may compromise assessment of key outcomes or in the opinion of the clinician, limit the ability of the patient to comply with the protocol;
- •7. Treatment with any of the following anti-cancer therapies prior to the first dose of tepotinib:
- •a. Radiation therapy, major surgery, or tumour embolization within 14 days prior to the first dose of study treatment. Palliative radiotherapy (for analgesia) is acceptable only if the irradiated field does not include target lesions;
- •b. Any systemic therapy within 28 days prior to the first dose of tepotinib;
- •8. Administration of any investigational treatment within 28 days prior to receiving the first dose of tepotinib;
- •9. Prior or concurrent malignancy. History of another primary malignancy except for:
- •a. Malignancy treated with curative intent and with no known active disease within 2 years before consent to molecular screening and of low potential risk for recurrence;
- •b. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease;
- •c. Adequately treated carcinoma-in-situ without evidence of disease;
- •10. Pregnancy, lactation, or inadequate contraception. Women must be post-menopausal, infertile, or use a reliable means of contraception. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to registration. Men must have been surgically sterilised or use a (double if required) barrier method of contraception.
研究者
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