ACTRN12622000973718招募中2 期
SHERLOCK: Phase 2 trial of sotorasib in combination with carboplatin-pemetrexed and bevacizumab-biosimilar as first line treatment for advanced non-squamous non-small cell lung cancerwith KRAS G12C mutation
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 52
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 either:
- •a)newly diagnosed, treatment naïve metastatic (Stage IV) non-squamous NSCLC, or
- •b)recurrent non-squamous NSCLC with no disease progression for at least 6 months following prior curative lung surgery and (neo)adjuvant chemotherapy, or prior curative concurrent chemoradiotherapy and immunotherapy maintenance, for non-resectable stage III cancer.
- •2.Presence of KRAS G12C mutation in tumour tissue
- •3.Sufficient tumour tissue should be available for molecular profiling by Next Generation Sequencing (NGS) or results available from molecular profiling of tumour tissue by NGS. If there is insufficient tissue for NGS testing, a repeat biopsy is strongly recommended. Acceptable platforms include, but are not limited to: FoundationOne Tissue CDx, Illumina TruSight Oncology 500 (TSO500)
- •4.Measurable disease according to RECIST 1.1. Lesions previously irradiated are not considered measurable unless they have unequivocally progressed after radiation.
- •5.ECOG performance status of 0 or 1
- •6.Adequate bone marrow function within 14 days prior to registration:
- •Platelets greater than or equal to 100 x 109/L
- •Absolute neutrophil count (ANC) greater than or equal to 1.5 x 109/L
- •Haemoglobin greater than or equal to 90 g/L
- •International normalized ratio (INR) less than or equal to 1.5
- •activated partial thromboplastin time (aPTT) less than or equal to 1.5 x ULN
- •7.Adequate liver function within 14 days prior to registration:
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 2.5 x institutional upper limit of normal (ULN) (or less than or equal to 5 x ULN if liver metastases are present).
- •8.Adequate renal function with no proteinuria within 14 days prior to registration:
- •Creatinine clearance greater than or equal to 60 mL/min. This can be determined using any of the following: 51Cr-EDTA, 99mTc-DTPA renography, 24-hour urine collection for creatinine clearance, or estimated using the Cockcroft-Gault formula
- •Urine dipstick with no proteinuria (i.e. either 0, trace, or 1+). If urine dipstick is greater than 1 then 24-hour urine collection is required, and must demonstrate less than or equal to 500 mg protein per day
- •9.QTc less than or equal to 470 msec in females and less than or equal to 450 msec in males (based on average of screening triplicates)
- •10.Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments
- •11.Signed, written informed consent (main study and tissue banking).
排除标准
- •1.Previous treatment with sotorasib, or KRAS G12C specific inhibitor, or pan-KRAS inhibitor
- •2.Concurrent driver mutation (including EGFR, ALK, ROS1, BRAF) where an approved targeted therapy is available
- •3.Mixed histology with any small cell or squamous component
- •4.Evidence of active bleeding or bleeding risk, including:
- •a tumour that compresses or invades major blood vessels or tumour cavitation that in the opinion of the investigator is likely to bleed
- •History of haemoptysis (>2.5 mL per event) in the last 3 months or severe bleeding
- •Bleeding disorders, haemorrhagic diathesis
- •Chronic systemic anticoagulation with aspirin > 100 mg/day, clopidogrel > 75 mg/day, ticagrelor > 90 mg BD, more than one anti-platelet drug, warfarin, heparin, enoxaparin, and other direct oral anticoagulants (e.g. apixaban, rivaroxaban, etc)
- •5.Medically uncontrolled hypertension or systolic blood pressure > 150 mmHg or diastolic blood pressure > 100 mmHg. If white coat” hypertension is suspected, a 24-hour continuous blood pressure recording is required to accurately determine blood pressure.
- •6.Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within 6 months prior to registration, unstable arrhythmias, or unstable angina
- •7.Significant peripheral vascular disease or cerebrovascular disease (including stroke or transient ischaemic attack within 6 months prior to registration)
- •8.Concurrent medical illness that may jeopardise the ability of the participant to undergo the procedures outlined in this protocol with reasonable safety
- •9.Severe infection within 4 weeks prior to registration including, but not limited to hospitalisation for management of infection, bacteraemia or sepsis.
- •10.Active hepatitis B, hepatitis C, or HIV. Chronic hepatitis B carrier with undetectable hepatitis DNA level is allowed. Serological testing is not mandatory unless clinically indicated.
- •11.Major surgery within 28 days prior to registration
- •12.Significant gastrointestinal disorder that results in significant malabsorption, requirement for intravenous alimentation, or inability to swallow oral tablet medication
- •13.History of a malignancy within 5 years prior to registration except for non-melanomatous carcinoma of the skin
- •14.Spinal cord compression, symptomatic and unstable brain metastases, except for those participants who have completed definitive therapy, are not on steroids equivalent to oral prednisone of > 10 mg/day, and have a stable neurological status for at least 2 weeks after commencement of the definitive therapy. Participants with untreated asymptomatic brain metastases can be eligible for inclusion if immediate definitive treatment is not indicated
- •15.Leptomeningeal disease
- •16.Known allergy or hypersensitivity to any of the study drugs or their excipients
- •17.Life expectancy of less than 3 months
- •18.Current enrolment or participation in another clinical study with an unregistered investigational product during the last 12 months, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study, in which case eligibility should be discussed with the Study Chair by contacting the NHMRC CTC.
- •19.Serious medical or psychiatric conditions that might limit the ability of the participant to comply with the protocol.
- •20.Pregnancy, lactation, or inadequate contraception. Women must be po
研究者
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