JPRN-jRCT2080224881已完成2 期
A Phase II, Assessing Efficacy of Osimertinib With Savolitinib in Patients With EGFRm+ MET+, Locally Advanced or Metastatic Non Small Cell Lung Cancer Who Have Progressed Following Treatment with Osimertinib
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 23
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
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Patients must be 18 years of age or more (20 years of age or more 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 (including either exon 19 deletion and/or L858R) which is not amenable to curative therapy.
- •- Documented radiologic disease progression following treatment with osimertinib (osimertinib does not need to be the most recent therapy).
- •- MET amplification/high expression as determined by FISH (central), IHC (central) or NGS (local) testing on tumour tissue collected following progression on prior osimertinib treatment.
- •- Available tissue from a recent biopsy for MET analysis or willingness to collect additional tissue for central testing.
- •- At least 1 lesion, not previously irradiated, not biopsied during the screening period, that can be accurately measured at baseline as 10 mm or more in the longest diameter (except lymph nodes which must have short axis 15 mm or more) with CT or MRI which is suitable for accurate repeated measurements.
- •- Received at least 1 but no more than 3 prior lines of therapy (may include investigational therapy) in the locally advanced/metastatic setting.
- •- No more than one prior line of chemotherapy regimen
- •- A chemotherapy regimen including a programmed cell death-1 (PD1) or a PD1 ligand 1 (PD L1) agent is acceptable, provided it was not the most recent line of therapy.
- •- No more than 2 prior lines of therapy containing EGFR TKI are acceptable
- •- Adequate haematological function defined as:
- •- Absolute neutrophil count 1500/microL microliter or more
- •- Haemoglobin 9 g/dL or more (no transfusion in the past 2 weeks)
- •- Platelets 100,000/microL microliter or more (no transfusion in the past 10 days)
- •- Adequate liver function
- •- ALT, AST 2.5 x or less ULN with total bilirubin ULN or less OR
- •- Total bilirubin >ULN to 1.5x or less ULN with ALT and AST ULN or less
- •- Adequate renal function -creatinine <1.5 times the institutional ULN OR a glomerular filtration rate 50 mL/min or more. 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 or more.
- •- 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 must be using highly effective contraceptive measures and have a negative pregnancy test.
- •- 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.
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 or more, 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 or more) Acute myocardial infarction Stroke or transient ischemic attack Uncontrolled hypertension (BP 150/95 mmHg or more 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 less or limited field radiation for palliation 7 days prior or less to starting study drug or has not recovered from side effects of such therapy.
- •- Major surgical procedures 28 days of beginning study drug or less or minor surgical procedures 7 days or less
- •- 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
- •- Known serious active infection e.g. tuberculosis or human immunodeficiency virus
- •- 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.
- •- Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values Absolute neutrophil count <1.5 x 109/L Platelet count <100 x 109/L Haemoglobin <90 g/L
- •- Prior or current treatment with a 3rd generation EGFR-TKI other than osimertinib.
- •- Prior or current treatment with savolitinib or
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