NL-OMON53471尚未招募3 期
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 - A study of Furmonertinib in Patients With NSCLC (FURMO-004)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 2
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
- •atients 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
- •Note: Measurable lesion can neither be subject to local therapy such as
- •radiotherapy nor used for biopsy in the Screening Period; if there is only 1
- •measurable lesion, this lesion will be permitted to be biopsied. However, the
- •baseline radiologic examination should be performed for this lesion at least 14
- •days after biopsy.
- •5. Histologically or cytologically documented, locally advanced or metastatic
- •non-squamous NSCLC not amenable to curative surgery or radiotherapy
- •6. Documented validated results confirming 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) assay or a validated polymerase
- •chain reaction (PCR) test with confirmation by Sanger sequencing performed at a
- •Clinical Laboratory Improvement Amendments (CLIA) or equivalently certified
- •laboratory.
- •* If local testing does not meet the above criteria, then a central test
- •designated by the Sponsor or a commercially available NGS assay should be
- •performed as specified in the laboratory manual.
- •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.
- •It is preferred that the specimen is prepared from the most recently
- •collected and available tumor tissue. See the laboratory manual for
- •instructions.
- •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/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 (unconjugated hyperbilirubinemia)
- •Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and
- •alkaline phosphatase (AP) <= 2.5 × ULN, with the following exceptions:
- •* Patients with documented liver metastases may have AST, ALT, and/or AP <= 5.0
- •* Patients with documented bone metastases may have AP <= 5.0 × ULN.
- 另有 4 项未显示
排除标准
- •Patients who meet any of the following criteria will be excluded from study
- •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
- •4. Pleural effusion, pericardial effusion, or ascites requiring recurrent
- •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
- •of investigational product.
- •Patients with uncontrolled human immunodeficiency virus (HIV) infection
- •(defined as CD4+ T cell count < 350 cells/µL).
- •Note: Patients must have been on established antiretroviral therapy (ART) for at
- •least four weeks and have an HIV viral load < 400 copies/mL prior to
- •enrollment). If the lower limit of detection of HIV viral load assay at the
- •higher than 400 copies/mL or with units other than copies/mL, patients with an
- •HIV viral load result lower than the lower limit of detection in the site are
- •considered eligible. Patients with unknown HIV infection status who do not
- •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., <=
- •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
- •infection that requires treatment.
- •Note: If a patient has a negative HBsAg test and a positive total HbcAb test at
- •screening, an HBV DNA test must also be performed to determine if the patient
- •has an HBV infection. 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.
- •6. In the setting of a pandemic or epidemic, screening for active infections
- •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), drug-induced ILD, radiation
- •pneumonitis, or active ILD
- •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
- •New York Heart Association (NYHA) Class III or IV cardiac dis
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