A Global, Phase 3, Randomized, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Firmonertinib Compared With Investigator's Choice of Osimertinib or Afatinib as First-Line Treatment in Participants Who Have Locally Advanced or Metastatic Non-Small-Cell Lung Cancer With Epidermal Growth Factor Receptor P-Loop and Alpha C-Helix Compressing (PACC) Uncommon Mutations (ALPACCA)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 480
- 试验地点
- 118
- 主要终点
- Progression Free Survival (PFS) determined by blinded independent central review (BICR)
研究概览
简要总结
Global, Phase 3, randomized, multicenter, open-label study evaluating the efficacy and safety of firmonertinib at a dose level of 240 mg QD compared to investigator's choice of osimertinib (80 mg QD) or afatinib (40 mg QD) in participants who have locally advanced or metastatic NSCLC with EGFR PACC mutations, and who have not received any prior therapy for advanced disease. Participants will be randomized in a 1:1 ratio to treatment with firmonertinib or osimertinib or afatinib and will take the assigned dose daily.
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
- •Key Eligibility Criteria:
- •Histologically or cytologically documented, locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) not amenable to curative surgery or radiotherapy.
- •Documented results of the presence of an Epidermal Growth Factor Receptor (EGFR) PACC mutation in tumor tissue or blood from local testing.
- •No prior systemic anticancer therapy regimens received for locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) including prior treatment with any Epidermal Growth Factor Receptor (EGFR)-targeting agents (e.g., previous (EGFR) TKIs, monoclonal antibodies, or bispecific antibodies).
- •Patients who have received prior neo-adjuvant and/or adjuvant chemotherapy, immunotherapy, or chemo radiotherapy for non-metastatic disease must have experienced a treatment free interval of at least 12 months.
- •Patients with asymptomatic CNS metastases are eligible.
排除标准
- 未提供
研究组 & 干预措施
EGFR-TKI inhibitor osimertinib or afatinib based on investigator's choice
干预措施: EGFR-TKI inhibitor based on investigator's choice (Drug)
Firmonertinib 240 mg
干预措施: Firmonertinib (Drug)
结局指标
主要结局
Progression Free Survival (PFS) determined by blinded independent central review (BICR)
时间窗: Until progression or death, assessed up to approximately 4 years
PFS is defined as the time from randomization to the first occurrence of disease progression as determined by BICR using RECIST v1.1, or death from any cause, whichever occurs first.
Confirmed overall response rate (ORR) as determined by BICR
时间窗: Until progression or death, assessed up to approximately 3 years
Confirmed ORR is defined as the percentage of participants with a confirmed CR or PR based on BICR assessment relative to the total number of participants.
次要结局
- Overall survival (OS)(Until death, assessed up to approximately 5 years)
- Investigator-assessed PFS(Until progression or death, assessed up to approximately 4 years)
- Investigator-assessed confirmed ORR(Until progression or death, assessed up to approximately 3 years)
- Duration of response (DOR)(Until progression or death, assessed up to approximately 4 years)
- Time to second Progression-free survival (PFS2)(Assessed up to approximately 5 years)
- Incidence and severity of adverse events (AEs), as a measure of safety and tolerability of firmonertinib(Assessed up to approximately 5 years)
- Change from baseline in safety-related clinical laboratory test results(Assessed up to approximately 5 years)