NL-OMON53437尚未招募不适用
A Phase 1b Dose Escalation and Dose Expansion Study Evaluating the Safety, Pharmacokinetics, and Antitumor Activity of Furmonertinib in Patients with Advanced or Metastatic Non-Small Cell Lung Cancer with Activating EGFR or HER2 Mutations - A study of Furmonertinib in Patients with NSCLC
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 5
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
- 18 至 99（—）
入选标准
- •Patients must meet the following criteria for study entry:
- •General Inclusion Criteria
- •1. Signed Informed Consent Form
- •2. Age >= 18 years at time of signing Informed Consent Form
- •3. Ability to comply with the study protocol, in the investigator*s judgment
- •4. Measurable disease per RECIST v1.1
- •Note: Measurable target lesions (TLs) can neither be subject to local therapy
- •such as radiotherapy nor used for biopsy in the screening period; if there is
- •only one measurable TL, this TL will be permitted to be biopsied. However, the
- •baseline radiologic examination should be performed for this lesion at least 14
- •days after biopsy.
- •5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •6. Life expectancy of >= 12 weeks
- •7. Adequate hematologic and organ function within 14 days prior to initiation
- •of study treatment, defined by the following:
- •Absolute neutrophil count >= 1500/µL
- •Hemoglobin >= 9 g/dL
- •Platelet count >= 100,000/µL
- •Total bilirubin <= 1.5 × upper limit of normal (ULN) or <= 3 × ULN in the
- •presence of documented Gilbert*s Syndrome
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 2.5 ×
- •ULN with the following exception:
- •- Patients with documented liver metastases may have AST and/or ALT <= 5.0 × ULN
- •Creatinine clearance >= 30 mL/min based on the Cockcroft-Gault estimation:
- •(140 * age) × (weight in kg) × (0.85 if female)
- •72 × (serum creatinine in mg/dL)
- •International normalized ratio (INR) <= 1.5 × ULN and activated partial
- •thromboplastin time (aPTT) <= 1.5 × ULN
- •Note: This applies only to patients who are not receiving therapeutic
- •anticoagulation. Patients receiving therapeutic anticoagulation should be on a
- •stable dose for at least 1 week prior to Cycle 1, Day 1.
- •8. For women of childbearing potential (WOCBPs): Agreement to remain abstinent
- •(refrain from heterosexual intercourse) or use contraception, and agreement to
- •refrain from donating eggs, as defined below:
- •A woman is considered to be of childbearing potential if she is
- •postmenarchal, has not reached a postmenopausal state >= 12 continuous months of
- •amenorrhea with no identified cause other than menopause), and is not
- •permanently infertile due to surgery (i.e., removal of ovaries, fallopian
- •tubes, and/or uterus) or another cause as determined by the investigator (e.g.,
- •Müllerian agenesis). The definition of childbearing potential may be adapted
- •for alignment with local guidelines or regulations.
- •WOCBPs must remain abstinent or use a barrier method such as a condom plus an
- •additional contraceptive method that together result in a failure rate of < 1%
- •per year during the treatment period and at least 60 days after the final dose
- •of furmonertinib. WOCBPs must refrain from donating eggs during the treatment
- •period and 6 months after the final dose of furmonertinib.
- •Examples of contraceptive methods with a failure rate of < 1% per year
- •include bilateral tubal ligation, male sterilization, hormonal oral
- •contraceptives that inhibit ovulation, hormone-releasing intrauterine devices,
- •and copper intrauterine devices.
- 另有 3 项未显示
排除标准
- •General Exclusion Criteria
- •Patients who meet any of the following criteria will be excluded from study
- •1. Inability or unwillingness to swallow pills
- •1. Inability to comply with study and follow-up procedures
- •2. Malabsorption syndrome or other condition that would interfere with enteral
- •3. Pleural effusion, pericardial effusion, or ascites requiring recurrent
- •drainage procedures biweekly or more frequently
- •Indwelling pleural or abdominal catheters may be allowed, provided the
- •patient has adequately recovered from the procedure, is hemodynamically stable
- •and symptomatically improved, and after discussion with the Sponsor.
- •4. Severe acute or chronic infections, including:
- •Uncontrolled acute infection, active infection that necessitates systemic
- •treatment or systemic antibiotic treatment within 2 weeks prior to the first
- •dose of furmonertinib.
- •Known history of human immunodeficiency virus (HIV) infection and/or acquired
- •immune deficiency syndrome. Patients with unknown HIV infection status who
- •don*t agree to take HIV test are not eligible.
- •Patients with active chronic hepatitis B or with active hepatitis C
- •infection, which includes patients who are hepatitis B surface antigen (HbsAg)
- •positive or hepatitis C virus (HCV) antibody positive at screening, are not
- •eligible until further definite quantitative testing of hepatitis B virus (HBV)
- •DNA (e.g., <= 2500 copies/mL or 500 IU/mL) and HCV RNA tests (e.g., <= lower
- •limit of detection) can conclusively rule out presence of active hepatitis B or
- •C infection that requires treatment.
- •Note: Patients who are carriers of HBV, with stable HBV infection (e.g., HBV
- •DNA quantitative test showed DNA <= 2500 copies/mL or 500 IU/mL) after medical
- •treatment or with cured hepatitis C are permitted to enroll. If the lower limit
- •of detection of HBV DNA assay in the site is higher than 2500 cps/mL or 500
- •IU/mL, patients with HBV DNA quantitative test result lower than the lower
- •limit of detection in the site are considered eligible.
- •5. In the setting of a pandemic or epidemic, screening for active infections
- •should be considered according to local or institutional guidelines or those of
- •applicable professional societies (e.g., American Society of Clinical Oncology
- •[ASCO] or European Society for Medical Oncology [ESMO]).
- •6. Previous interstitial lung disease (ILD), drug induced ILD, radiation
- •pneumonitis; or active ILD.
- •7. History of or active clinically significant cardiovascular dysfunction,
- •including the following:
- •History of stroke or transient ischemic attack within 6 months prior to first
- •dose of furmonertinib
- •History of myocardial infarction within 6 months prior to first dose of
- •furmonertinib
- •New York Heart Association Class III or IV cardiac disease or congestive
- •heart failure requiring medication
- •Uncontrolled arrhythmias, history of or active ventricular arrhythmia
- •requiring medication
- •Coronary heart disease that is symptomatic or unstable angina
- •8. Mean resting QT interval corrected through use of Fridericia*s formula
- •(QTcF) > 470 ms, obtained from triplicate electrocardiograms (ECGs), using the
- •screening clinic ECG machine-derived QTcF value.
- 另有 2 项未显示
研究者
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