A Global, Phase 3, Randomized, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Furmonertinib Compared to Platinum-Based Chemotherapy as First-Line Treatment for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer with Epidermal Growth Factor Receptor Exon 20 Insertion Mutations - FURVENT

Imanishi Naoki0 个研究点目标入组 42 人开始时间: 2023年6月3日最近更新: 2024年4月1日

适应症

试验速览

阶段: 3 期
状态: 招募中
发起方
入组人数: 42

研究概览入排标准研究者记录与标识符相似试验

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 meet the following criteria for study entry:
•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
•5. Histologically or cytologically documented, locally advanced or metastatic non-squamous NSCLC not amenable to curative surgery or radiotherapy
•6. Documented results of the presence of an EGFR exon 20 insertion mutation (i.e., addition of 1 or more amino acids) in tumor tissue or blood from local or central testing via a validated next-generation sequencing (NGS) or a validated polymerase chain reaction (PCR) assay performed at a Clinical Laboratory Improvement Amendments (CLIA) or equivalently certified laboratory or in a laboratory certified by a nationally recognized entity.
•7. Consent to provide archival tumor tissue specimen (formalin-fixed, paraffin-embedded [FFPE] tissue block [preferred] or at least 15 unstained, serially cut sections on slides from FFPE tumor specimen). The specimens should be provided during screening or no later than within 30 days of Cycle 1, Day 1 and must be accompanied by a pathology report.
•8. No prior systemic anticancer therapy regimens received for locally advanced or metastatic NSCLC including prior treatment with any EGFR-targeting agents (e.g., previous EGFR tyrosine kinase inhibitors (EGFR-TKIs), monoclonal antibodies, or bispecific antibodies)
•9. Patients who have received prior neo-adjuvant and/or adjuvant chemotherapy, immunotherapy, or chemoradiotherapy for non-metastatic disease must have experienced a treatment-free interval of at least 12 months.
•10. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
•11. Life expectancy of >= 12 weeks
•12. Adequate hematologic and organ function within 14 days prior to initiation of study treatment, defined by the following:
•- Absolute neutrophil count >= 1500/microL
•- Hemoglobin >= 9 g/dL
•- Platelet count >= 100,000/microL
•- Total bilirubin <= 1.5 x upper limit of normal (ULN) or <= 3 x ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia)
•- Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (AP) <= 2.5 x ULN, with the following exceptions:
•-- Patients with documented liver metastases may have AST, ALT, and/or AP <= 5.0 x ULN.
•-- Patients with documented bone metastases may have AP <= 5.0 x ULN.
•- Creatinine clearance >= 45 mL/min on the basis of the Cockcroft-Gault estimation
•- International normalized ratio (INR) <= 1.5 x ULN and activated partial thromboplastin time (aPTT) <= 1.5 x ULN
•13. For women of childbearing potential (WOCBP): 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., Mullerian agenesis). The definition of childbearing potential may be adapted for alignment with local guidelines or regulations.
•- WOCBP must remain abstinent or utilize a barrier method such as a condom plus an additional contraceptive method that togethe

排除标准

•Patients who meet any of the following criteria will be excluded from study entry:
•1. Inability or unwillingness to swallow pills
•2. Inability to comply with study and follow-up procedures
•3. Malabsorption syndrome or other conditions that would interfere with enteral absorption
•4. 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 has symptomatically improved.
•5. 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 investigational product.
•- Patients with uncontrolled human immunodeficiency virus (HIV) infection (defined as CD4+ T cell count < 350 cells/microL).
•- Patients with active chronic hepatitis B or with active hepatitis C infection, which includes patients who are hepatitis B surface antigen (HBsAg)-positive, or HbsAg-negative but HbcAb-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 ribonucleic acid (RNA) tests (e.g., <= lower limit of detection) can conclusively rule out presence of active hepatitis B or C infection that requires treatment.
•6. 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 or European Society for Medical Oncology).
•7. Previous interstitial lung disease (ILD) (including drug-induced ILD) or active ILD/radiation pneumonitis
•8. 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 study drug
•- History of myocardial infarction within 6 months prior to first dose of study drug
•- New York Heart Association (NYHA) Class III or IV cardiac disease or congestive heart failure requiring medication
•- Uncontrolled arrhythmias, or history of or active ventricular arrhythmia requiring medication
•- Coronary heart disease that is symptomatic or unstable angina
•9. Mean resting corrected QT interval (QTc) > 470 msec, obtained from triplicate electrocardiograms (ECGs) based on Fridericia's formula (QTcF)
•10. Clinically significant prolonged QT interval or other arrhythmia or clinical status considered by investigators that may increase the risk of prolonged QT interval (e.g., complete left bundle branch block, third-degree atrioventricular block, second degree heart block, PR interval > 250 msec, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives, serious hypokalemia, heart failure) or current use of the drugs that may lead to prolonged QT interval/torsades de pointes.
•11. Symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab
•12. Significant traumatic injury or major surgical procedure within 4 weeks prior to Day 1 of Cycle 1
•13. Patients with chronic diarrhea, short bowel syndrome or significant upper GI surgery including gastric resection, a history of inflammato

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发起方

Imanishi Naoki

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