NCT06765109招募中3 期
A Phase 3 Study of the Selective Anaplastic Lymphoma Kinase (ALK) Inhibitor NVL-655 Compared to Alectinib in First-Line Treatment of Patients With ALK-Positive Advanced Non-Small Cell Lung Cancer (ALKAZAR)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 450
- 试验地点
- 223
- 主要终点
- Progression-free survival (PFS) per blinded independent central review (BICR)
研究概览
简要总结
Multicenter, randomized, controlled, open-label, Phase 3 study designed to demonstrate that neladalkib (NVL-655) is superior to alectinib in prolonging progression-free survival (PFS) in patients with treatment-naïve, Anaplastic Lymphoma Kinase (ALK) positive, advanced Non-Small Cell Lung Cancer (NSCLC).
详细描述
Patients will be randomized in a 1:1 ratio (approximately 225 in each arm) to receive either neladalkib (NVL-655) or alectinib.
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
- Single (Outcomes Assessor)
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
- •Histologically or cytologically confirmed locally advanced (not amenable for multimodality treatment) or metastatic Non-small Cell Lung Cancer (NSCLC)
- •Documented Anaplastic Lymphoma Kinase (ALK) rearrangement via testing of tissue or blood
- •No prior systemic anticancer treatment for NSCLC (adjuvant/neoadjuvant chemotherapy allowed if 12 months prior to randomization; prior ALK tyrosine kinase inhibitor [TKI] such as alectinib is not allowed in any setting)
- •Measurable disease (1 or more target lesions per Response Evaluation Criteria in Solid Tumors [RECIST] 1.1)
- •Pretreatment tumor tissue
排除标准
- •Patient's cancer has a known oncogenic driver alteration other than ALK.
- •Known allergy/hypersensitivity to excipients of neladalkib or alectinib.
- •Ongoing or recent radiotherapy as per protocol-specified timeframes prior to randomization
- •Major surgery within 4 weeks prior to randomization
- •Uncontrolled clinically relevant infection requiring systemic therapy
- •Known active tuberculosis, or active Hepatitis B or C
- •QT corrected for heart rate by Fridericia's formula (QTcF) > 470 msec on repeated assessments
- •Clinically significant cardiovascular disease
- •Brain metastases associated with progressive neurological symptoms or requiring increasing doses of corticosteroids to control CNS disease
- •Active malignancy requiring therapy within 2 years prior to randomization
研究组 & 干预措施
Neladalkib (NVL-655)
Experimental
150mg taken orally once daily (QD)
干预措施: Neladalkib (NVL-655) (Drug)
Alectinib
Active Comparator
600mg taken orally twice daily (BID)
干预措施: Alectinib (Drug)
结局指标
主要结局
Progression-free survival (PFS) per blinded independent central review (BICR)
时间窗: Up to 5 years after first patient dosed
Time from randomization to BICR-assessed radiographic disease progression or death
次要结局
- Overall survival (OS)(Up to 5 years after first patient dosed)
- Progression-free survival (PFS) per investigator assessment(Up to 5 years after first patient dosed)
- Time to intracranial progression per BICR(Up to 5 years after first patient dosed)
- Intracranial objective response rate (IC-ORR)(Up to 5 years after first patient dosed)
- Intracranial duration of response (IC-DOR)(Up to 5 years after first patient dosed)
- Objective response rate (ORR)(Up to 5 years after first patient dosed)
- Duration of response (DOR)(Up to 5 years after first patient dosed)
- Intracranial progression per investigator assessment(Up to 5 years after first patient dosed)
- Treatment-emergent adverse events (TEAEs) and changes in clinically relevant laboratory parameters(Up to 5 years after first patient dosed)
- Patient-reported measures in health-related quality of life (QoL)(Up to 5 years after first patient dosed)
- Patient-reported measures in lung cancer symptoms and side effects of treatment(Up to 5 years after first patient dosed)
- Patient-reported measures in patient functioning(Up to 5 years after first patient dosed)
研究者
研究点 (223)
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