A Randomized, Phase 3 Study of Poziotinib in Previously Treated Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Harboring HER2 Exon 20 Mutations (PINNACLE)
试验速览
- 阶段
- 3 期
- 状态
- 暂停
- 入组人数
- 268
- 试验地点
- 1
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
The primary purpose of this study is to compare the progression-free survival (PFS) in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring human epidermal growth factor receptor 2 (HER2) exon 20 mutations when treated with poziotinib versus docetaxel.
详细描述
This is a Phase 3, active-controlled, multicenter study to compare the efficacy and safety/tolerability of poziotinib versus docetaxel in previously treated participants with locally advanced or metastatic NSCLC harboring HER2 exon 20 mutations.
Participants will be randomized in a 2:1 ratio to:
- Arm A: Poziotinib 8 milligrams (mg), twice daily (BID) or
- Arm B: Docetaxel 75 milligrams per meter square (mg/m^2)
The Screening Period lasts up to 21 days prior to Cycle 1, Day 1 (C1D1). Participants will be treated in 21-day cycles or until disease progression, death, intolerable adverse events (AEs), initiation of non-protocol anti-cancer treatment, or other protocol-specified reasons.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant must:
- •Be willing and capable of providing signed and dated Informed Consent, adhering to dosing and visit schedules, and meeting the study requirements
- •Have histologically or cytologically confirmed NSCLC
- •Have at least one measurable NSCLC target lesion per RECIST v.1.1 by local assessment
- •Participant has had at least one prior systemic treatment for locally advanced or metastatic NSCLC, including platinum and a checkpoint inhibitor (CPI) therapy, unless the investigator affirms that a CPI was not medically indicated.
- •Have documentation of HER2 exon 20 mutation
- •Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
- •Have adequate hematologic, hepatic, and renal function at Baseline as per protocol
排除标准
- •Participant:
- •Has had previous treatment with poziotinib for treatment of NSCLC
- •Has EGFR or anaplastic lymphoma kinase (ALK) genome tumor alterations
- •Has had previous treatment with docetaxel for locally advanced or metastatic NSCLC. If docetaxel was received in the neo-adjuvant or adjuvant setting, progressive disease must have occurred ≥6 months after the last dose to be eligible
- •Has spinal cord compression or leptomeningeal disease
- •Has a high risk of cardiac disease, as determined by the Investigator
- •Has a history of, or signs of Grade ≥2 pneumonitis on current imaging studies
- •Is unable to take drugs orally
- •Is pregnant or breast-feeding
研究组 & 干预措施
Poziotinib 8 mg
Participants will receive poziotinib 8 mg, orally, BID, in 21 day cycles or until disease progression, death, intolerable adverse events (AEs), initiation of non-protocol anti-cancer treatment, or other protocol-specified reasons for participant withdrawal from the study.
干预措施: Poziotinib (Drug)
Docetaxel 75 mg/m^2
Participants will receive docetaxel 75 mg/m^2, intravenously (IV) on Day 1 of each 21-day treatment cycle or until disease progression, death, intolerable AEs, initiation of non-protocol anti-cancer treatment, or other protocol-specified reasons for participant withdrawal from the study.
干预措施: Docetaxel (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: Up to approximately 5 years
PFS is defined as the time (in months) from the start of the study treatment to the date of first documented disease progression by central radiographic evaluation per the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v.1.1) or death due to any cause, whichever occurs first.
次要结局
- Overall survival (OS)(Up to approximately 5 years)
- Objective Response Rate (ORR)(Up to approximately 5 years)
- Disease Control Rate (DCR)(Up to approximately 5 years)