jRCT2031220455进行中（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 (NSCLC) with Activating EGFR or HER2 Mutations
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 15
- 主要终点
- Number of incidence and severity of adverse events (AEs)
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
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Key Inclusion Criteria:
- •Histologically or cytologically documented, locally advanced or metastatic NSCLC not amenable to curative surgery or radiotherapy
- •Disease that has progressed after at least one available standard therapy; or for whom standard therapy has proven to be ineffective, intolerable, or considered inappropriate, or for whom a clinical trial of an investigational agent is a recognized standard of care.
- •Documented radiologic disease progression during or after the last systemic anti-cancer therapy before the first dose of furmonertinib.
- •For patients with EGFR mutations sensitive to osimertinib, the patient must have received osimertinib prior to study enrollment in regions where osimertinib is approved, including the United States (US).
- •Stage 1 dose escalation and backfill cohorts and Stage 2 Cohorts 1, 2, 3, and 4
- •Patients with CNS metastases (including leptomeningeal disease) are eligible, provided they meet the criteria.
- •Stage 1 Dose Escalation and Backfill Cohorts Inclusion Criteria
- •Documented validated results from local testing of tumor tissue or blood confirming the presence of an activating, including uncommon, EGFR mutation or HER2 exon 20 insertion mutation performed at a CLIA-or equivalently certified laboratory.
- •Stage 2 Cohort 1 Previously Treated, Locally Advanced or Metastatic NSCLC Patients with EGFR exon 20 Insertion Mutations Inclusion Criteria
- •Documented validated results from local testing of either tumor tissue or blood confirming the presence of EGFR exon 20 insertion mutations, performed at a CLIA- or equivalently certified laboratory
- •The patient must have experienced disease progression or have intolerance to treatment with platinum-based chemotherapy.
- •Stage 2 Cohort 2 Previously treated, Locally Advanced or Metastatic NSCLC Patients with HER2 exon 20 Insertion Mutations Inclusion Criteria
- •Documented validated results from local testing of either tumor tissue or blood confirming the presence of HER2 exon 20 insertion mutations, performed at a CLIA- or equivalently certified laboratory.
- •The patient must have experienced disease progression or have intolerance to treatment with platinum-based chemotherapy
- •In regions in which fam-trastuzumab deruxtecan-nxki is approved and available for adult patients with unresectable or metastatic NSCLC whose tumors have activating HER2 exon 20 mutations, the patient must have received or be considered not appropriate to receive fam-trastuzumab deruxtecan-nxki.
- •Stage 2 Cohort 3 Previously Treated, Locally Advanced or Metastatic NSCLC Patients with EGFR Activating Mutations
- •Documented validated results from local testing of either tumor tissue or blood confirming the presence of an EGFR activating mutation, performed at a CLIA- or equivalently certified laboratory.
- •Patients with CNS metastases may be eligible if meeting additional protocol specified criteria.
- •Stage 2 Cohort 4 Untreated or Previously Treated EGFR-TKI-Naive, Locally Advanced or Metastatic NSCLC Patients with EGFR Uncommon Mutations Excluding EGFR Exon 20 Insertions Inclusion Criteria.
- •Previously untreated in the locally advanced or metastatic setting or have progressed after at least 1 available standard therapy, or for whom standard therapy has proven to be ineffective, intolerable, or considered inappropriate
- •Documented validated results from local testing of either tumor tissue or blood confirming the presence of an EGFR Uncommon mutation, performed at a CLIA- or equivalently certified laboratory.
- •Representative mutations include, but are not limited to:
- •G719X, S768I, E709X, G779F, L747X, V774M, E709_T710delinsD, R776C/H, G724S, E736K, I740_K745dup, N771G, K757M/R, V769L/M, T854X, T751_I759delinsN
排除标准
- •Key Exclusion Criteria
- •Treatment with chemotherapy, targeted therapy, biologic therapy, or an investigational agent as anti-cancer therapy within 3 weeks or 5 elimination half-lives prior to initiation of furmonertinib, whichever is shorter.
- •Radiation therapy as cancer therapy within 4 weeks prior to initiation of furmonertinib.
- •Palliative radiation to bone metastases within 2 weeks prior to initiation of furmonertinib.
- •AEs from prior anticancer therapy that have not resolved to Grade <= 1 except for alopecia or Grade <= 2 peripheral neuropathy.
- •Stage 2 Cohort 4 Untreated or Previously Treated EGFR-TKI-Naive, Locally Advanced or Metastatic NSCLC Patients with Uncommon EGFR Mutations Exclusion Criteria
- •Prior treatment with any EGFR-TKIs
- •Progression during neoadjuvant or adjuvant therapy (e.g., chemotherapy, radiotherapy, immunotherapy or investigational agents) or within 12 months of completion of above therapies
结局指标
主要结局
Number of incidence and severity of adverse events (AEs)
时间窗: Up to 36 months after first dose
as a measure of safety and tolerability of Furmonertinib
次要结局
未报告次要终点
研究者
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