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临床试验/NL-OMON55568
NL-OMON55568已完成2 期

A Phase 2 Study of Poziotinib in Patients with Non-Small Cell Lung Cancer (NSCLC), Locally Advanced or Metastatic, with EGFR or HER2 Exon 20 Insertion Mutation (ZENITH20) - SPI-POZ-202

Spectrum Pharmaceuticals, Inc.0 个研究点目标入组 80 人开始时间: 待定最近更新:
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适应症

试验速览

阶段
2 期
状态
已完成
入组人数
80
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
18 至 99（—）

入选标准

  • •1. Patient is at least 18 years of age
  • •2. Patient must be willing and capable of giving written Informed
  • •Consent, adhering to dosing and visit schedules, and meeting all study
  • •requirements
  • •3. Patient has histologically or cytologically confirmed locally advanced
  • •or metastatic non-small cell lung cancer (NSCLC) that is not amenable to
  • •treatment with curative intent
  • •4. Prior treatment status:
  • •Cohorts 1 and 2: Patient has had at least one prior systemic treatment for
  • •locally advanced or metastatic NSCLC
  • •Cohorts 3 and 4: Patient is treatment-naïve for locally advanced or
  • •metastatic NSCLC and eligible to receive first-line treatment with poziotinib
  • •as determined by the Investigator. Adjuvant/neo-adjuvant therapies
  • •(chemotherapy, radiotherapy, or investigational agents) are permissible as long
  • •as they end at least 15 days prior to study entry.
  • •Cohort 5: Patients who meet the criteria for enrollment in Cohort 1 to 4, but
  • •the enrollment in the respective cohort has been closed • Cohort 6: Patients
  • •with EGFR mutation-positive NSCLC who progressed while on treatment with
  • •first-line osimertinib. • Cohort 7: Patient has had at least one prior systemic
  • •treatment for locally advanced or metastatic NSCLC
  • •5. Tissue and plasma samples for mutation confirmation: • Cohorts 1 to 5:
  • •Patient has adequate tumor tissue obtained from a biopsy or surgical procedure
  • •to enable molecular profiling for retrospective central laboratory confirmation
  • •of the mutation. If tissue is not available, the patient must have biopsy
  • •accessible disease and must be willing to undergo a biopsy to provide an
  • •appropriate tissue sample prior to receiving treatment in the study. • Cohort
  • •6: Either tissue or plasma samples after osimertinib progression. • Cohort 7:
  • •Either tissue or plasma samples.
  • •6. Patient is positive for EGFR or HER2 exon 20 mutations based on tissue
  • •Cohorts 1 and 3: Documented EGFR exon 20 insertion mutation
  • •(including duplication mutations) using a next generation sequencing diagnostic
  • •test, such as OncoMine Comprehensive Assay (OCA) or FoundationOne Assay, or by
  • •an FDA approved test (eg, cobas® EGFR mutation test v2 or therascreen EGFR RGQ
  • •PCR kit) performed by a US CLIA certified and locally licensed clinical
  • •laboratory or similarly accredited lab for ex-US sites using tissue samples
  • •Cohorts 2 and 4: Documented HER2 exon 20 insertion mutation
  • •(including duplication mutations) using a next generation sequencing diagnostic
  • •test, such as OncoMine Comprehensive Assay (OCA) or FoundationOne Assay,
  • •performed by a US CLIA certified and locally licensed clinical laboratory or
  • •similarly accredited lab for ex-US sites using tissue samples
  • •Cohort 6: Documented acquired EGFR mutation (tested after osimertinib
  • •progression) who have progressed while on first-line osimertinib treatment
  • •using tissue or plasma tested with a next generation sequencing assay. • Cohort
  • •7: Documented EGFR or HER2 activating mutations using tissue or plasma tested
  • •with a next-generation sequencing assay.
  • •7. Patient has measurable NSCLC disease, as per the Response Evaluation
  • •Criteria in Solid Tumors (RECIST, version 1.1). (Text removed).
  • •8. Brain metastases may be allowed if patient's condition is stable,
  • •defined as clinically asymptomatic, no requirement for high dose or increasing
  • •dose of syste

排除标准

  • •1. Patient has:
  • •All Cohorts: EGFR T790M
  • •Cohorts 1 to 5: EGFR exon 20 point mutation
  • •Cohort 7: EGFR Exon 19 deletion and L858R or HER2 T798I mutations, EGFR and
  • •HER2 Exon 20 insertion mutation
  • •2. Patient has had previous treatment with poziotinib or any other EGFR or HER2
  • •exon 20 insertion mutation-selective tyrosine kinase inhibitor (TKI) prior to
  • •study participation. The currently approved TKIs (ie, erlotinib, gefitinib,
  • •afatinib, osimertinib) are not considered to be exon
  • •20 insertion-selective and are permissible (Cohorts 1 and 2).
  • •3. Patient is concurrently receiving chemotherapy, biologics, immunotherapy
  • •for cancer treatment; systemic anti-cancer treatment or investigational
  • •treatment should not be used within 2 weeks or 5 halflives, whichever is
  • •longer; local radiation therapy for bone pain may be allowed.
  • •4. Patient has a history of congestive heart failure (CHF) Class III/IV
  • •according to the New York Heart Association (NYHA) Functional Classification or
  • •serious cardiac arrhythmias requiring treatment
  • •5. Patient has a high risk of cardiac disease, as determined by the
  • •Investigator, may undergo either echocardiogram (ECHO) or multi-gated
  • •acquisition (MUGA) during Screening and has a cardiac ejection fraction <50%.
  • •6. Patient has had other malignancies within the past 3 years, except for
  • •stable non-melanoma skin cancer, fully treated and stable early stage prostate
  • •cancer or carcinoma in situ of the cervix or breast without need of treatment
  • •7. Patient is confirmed to have clinically significant or recent acute
  • •gastrointestinal disease presenting as diarrhea and/or coloenteritis as a main
  • •symptom (ie, acute enteritis, malabsorption, or Common Terminology Criteria for
  • •Adverse Events (CTCAE, version 4.03) Grade 2 or above diarrhea due to other
  • •etiologies)
  • •8. Patient has an active Grade >=2 skin disorder, rash, mucositis, or skin
  • •infection that needs medication or therapy or existing Grade >=2 skin toxicity
  • •from previous therapies; Grade >=2 neuropathy, Grade >=2 pneumonitis.
  • •9. Patient is unable to take drugs orally due to disorders or diseases that may
  • •affect gastrointestinal function, such as inflammatory bowel diseases (eg,
  • •Crohn's disease, ulcerative colitis) or malabsorption syndrome, or procedures
  • •that may affect gastrointestinal function, such
  • •as gastrectomy, enterectomy, or colectomy
  • •10. Patient has an active liver disease or biliary tract disease (except for
  • •Gilbert's disease, asymptomatic biliary stones, liver metastasis, or stabilized
  • •chronic liver diseases)
  • •11. Patient has known hypersensitivity to poziotinib or has a history of
  • •allergic reactions attributed to chemically similar compounds or other tyrosine
  • •kinase inhibitors (TKIs)
  • •12. Patient has an active uncontrolled infection, underlying medical condition,
  • •or other serious illness that would not be appropriate for this study
  • •13. Patient has unstable, uncontrolled, active bleeding disorders that the
  • •investigator considers that the patient could be at increased risk or not be
  • •suitable for treatment in this study
  • •14. Patient is pregnant or breast-feeding.
  • •15. Cohort 5 only: Patient is eligible for treatment in an open cohort (Cohorts

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