2024-517553-26-00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)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 233
- 试验地点
- 68
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
To evaluate the efficacy of NVL-655 compared to alectinib in patients with treatment-naïve ALK-positive advanced NSCLC
研究设计
- 分配方式
- Not Applicable
- 主要目的
- End of Trial (EOT)
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Patients must meet all of the following criteria to be eligible to enroll in the study:
- •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 (archived or a fresh biopsy)
排除标准
- •Patient’s cancer has a known oncogenic driver alteration other than ALK.
- •Known allergy/hypersensitivity to excipients of NVL-655 or alectinib.
- •Major surgery within 4 weeks prior to randomization
- •Ongoing or recent radiotherapy as per protocol-specified timeframes prior to randomization
- •Uncontrolled clinically relevant infection requiring systemic therapy
- •Known active tuberculosis, known 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
结局指标
主要结局
Progression-free survival (PFS)
Progression-free survival (PFS)
次要结局
- 1) - Overall survival (OS) - Progression-free survival (PFS) per investigator assessment - Time to intracranial progression per blinded independent central review (BICR) - Intracranial objective response rate (IC-ORR) - Intracranial duration of response (IC-DOR) - Objective response rate (ORR) - Duration of response (DOR) - Time to intracranial progression, IC-ORR, IC-DOR, ORR, and DOR
- 2) Incidence and severity of treatment-emergent adverse events (TEAEs) and changes in clinically relevant laboratory parameters
- 3) Changes in patient-reported outcomes (PROs)
研究者
Medical
Scientific
Nuvalent Inc.
研究点 (68)
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