EUCTR2018-003012-51-DK进行中（未招募）1 期
A Phase II Study Assessing the Efficacy of Osimertinib in Combination with Savolitinib in Patients with EGFRm+ and MET+, Locally Advanced or Metastatic Non Small Cell Lung Cancer who have Progressed Following Treatment with Osimertinib - SAVANNAH
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 360
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Patients must be =18 years of age (=20 years of age in Japan). All genders are permitted.
- •- Histologically or cytologically confirmed locally advanced or metastatic EGFRm+ NSCLC harbouring an EGFR mutation known to be associated with EGFR TKI sensitivity and permitted in the osimertinib national label (such as either exon 19 deletion and/or L858R) which is not amenable to curative therapy.
- •- Documented radiologic disease progression on first line osimertinib.
- •- MET-amplification and/or overexpression (FISH10+ and/or IHC90+) as determined by FISH (central) and IHC (central) testing on tumour sample collected following progression on 1L osimertinib treatment.
- •- Available tumour sample for central MET FISH and IHC analysis or willingness to collect additional tissue for central testing which fulfils the following requirements: Obtained following progression on previous osimertinib therapy; obtained within 2 years of submission for MET analysis; sufficient tissue to meet the minimum tissue requirement defined in the current Laboratory Manual.
- •- At least 1 lesion, not previously irradiated, not biopsied during the screening period, that can be accurately measured at baseline as =10 mm in the longest diameter (except lymph nodes which must have short axis =15 mm) with CT or MRI which is suitable for accurate repeated measurements. If only 1 measurable lesion exists, it is acceptable to be used as long as baseline tumour assessment scans are done at least 14 days after the screening tumour sample collection is performed.
- •- Prior lines of therapy in locally advanced/metastatic setting: Only prior
- •1L osimertinib treatment in metastatic setting is permitted.
- •- Adequate haematological function defined as:
- •- Absolute neutrophil count =1500/µL
- •- Haemoglobin =9 g/dL (no transfusion in the past 2 weeks)
- •- Platelets =100,000/µL (no transfusion in the past 10 days)
- •- Adequate liver function
- •- ALT, AST =2.5 x ULN with total bilirubin = ULN
- •- Total bilirubin >ULN to =1.5x ULN with ALT and AST = ULN
- •- Adequate renal function - creatinine <1.5 times the institutional ULN OR a glomerular filtration rate =50 mL/min. Confirmation of creatinine clearance is only required when creatinine is >1.5 times ULN.
- •- Adequate coagulation parameters - INR <1.5 x ULN and activated partial thromboplastin time <1.5 x ULN unless patients are receiving therapeutic anti coagulation which affects these parameters.
- •- Patients with known tumour thrombus or deep vein thrombosis are eligible if clinically stable on low molecular weight heparin for =2 weeks. The use of direct oral anticoagulants such as apixaban/rivaroxaban will be accepted as treatment for cancer-related thromboembolism treatment. The use of warfarin for oral anticoagulation is not recommended.
- •- ECOG/WHO performance status of 0 or 1 with no deterioration over the previous 2 weeks and a minimum life expectancy of 12 weeks.
- •- Females of childbearing potential should be willing to use adequate contraceptive measures, should not be breast feeding and must have a negative pregnancy test if of childbearing potential, or must have evidence of non-childbearing potential.
- •- Males with a female partner of childbearing potential should be willing to use barrier contraception during the study and for 6 months following discontinuation of study drug.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects
排除标准
- •- Unresolved toxicities from any prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 at the time of starting study treatment with the exception of alopecia and Grade 2 prior platinum therapy related neuropathy.
- •- As judged by the investigator, active gastrointestinal disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of oral therapy (eg, ulcerative disease, uncontrolled nausea, vomiting, diarrhoea Grade =2, malabsorption syndrome or previous significant bowel resection).
- •- Any of the following cardiac diseases currently or within the last 6 months:
- •Unstable angina pectoris
- •Congestive heart failure (New York Heart Association [NYHA] =Grade 2)
- •Acute myocardial infarction
- •Stroke or transient ischemic attack
- •Uncontrolled hypertension (BP =150/95 mmHg despite medical therapy).
- •Mean resting correct QT interval (QTcF) >470 msec for women and >450 msec for men at Screening, obtained from 3 ECGs using the screening clinic ECG machine derived QTcF value.
- •Any factors that may increase the risk of QTcF prolongation or risk of arrhythmic events such as heart failure, chronic hypokalaemia not correctable with supplements, congenital or familial long QT syndrome, family history of unexplained sudden death under 40 years of age in first-degree relatives or any concomitant medication known to prolong the QT interval and cause Torsade de Pointes.
- •Any clinically important abnormalities in rhythm, conduction or morphology of resting ECGs, eg, complete left bundle branch block, third degree heart block, second degree heart block, P-R interval >250 msec.
- •Acute coronary syndrome
- •- Wide field radiotherapy (including therapeutic radioisotopes such as strontium 89) administered =28 days or limited field radiation for palliation =7 days prior to starting study drug or has not recovered from side effects of such therapy.
- •- Major surgical procedures =28 days of beginning study drug or minor surgical procedures =7 days
- •- Evidence of severe or uncontrolled systemic diseases, including renal transplant, active bleeding diatheses or uncontrolled hypertension, which in the investigator’s opinion makes it undesirable for the patient to participate
- •- Active hepatitis B or C or known serious active infection e.g. tuberculosis or human immunodeficiency virus. Viral testing is not required for assessment of eligibility for the study.
- •- Presence of other active cancers, or history of treatment for invasive cancer, within the last 5 years. Patients with Stage I cancer who have received definitive local treatment at least 3 years previously, and are considered unlikely to recur are eligible. All patients with previously treated in situ carcinoma (ie, non-invasive) are eligible, as are patients with history of non-melanoma skin cancer.
- •- Spinal cord compression or brain metastases unless asymptomatic, stable and not requiring steroids for at least 2 weeks prior to start of study treatment.
- •- Past medical history of interstitial lung disease(ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD.
- •- History of liver cirrhosis of any origin and clinical stage; or history of
- •other serious liver disease or chronic disease with relevant liver involvement, with or without normal LFTs.
- •- Prior or current treatment with a 3rd generation EGFR-TKI other than osimertinib.
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