CTRI/2020/11/029082进行中（未招募）3 期
A Phase 3, Randomized study of Amivantamab and Lazertinib Combination Therapy Versus OsimertinibVersus Lazertinib as First-Line Treatment in Patientswith EGFR-Mutated Locally Advanced or MetastaticNon-Small Cell Lung Cancer.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,000
- 试验地点
- 5
- 主要终点
- Progression-Free Survival according to RECIST v1.1 by Blinded Independent Central Review
研究概览
简要总结
The purpose of this study is to assess the efficacy of the amivantamab and lazertinib combination, compared with osimertinib, in participants with epidermal growth factor receptor (EGFR) mutation (Exon 19 deletions [Exon 19del] or Exon 21 L858R substitution) positive, locally advanced or metastatic non-small cell lung cancer (NSCLC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.99 Year(s)（—）
- 性别
- All
入选标准
- •Participant must have histologically or cytologically confirmed, locally advanced or metastatic non-small cell lung cancer (NSCLC) not amenable to curative therapy.
- •Participant must have a tumor that was previously determined to have exon 19 deletions (Exon 19del) or Exon 21 L858R substitution, as detected by an food and drug administration (FDA)-approved or other validated test in a clinical laboratory improvement amendments (CLIA) certified laboratory (sites in the United states [US]) or an accredited local laboratory (sites outside of the US) in accordance with site standard of care. The biopsy must have been obtained at or after the diagnosis of advanced disease.
- •Unstained tumor tissue (in a quantity sufficient to allow for central analysis of epidermal growth factor receptor (EGFR) mutation status, see Laboratory Manual) and blood (for circulating tumor deoxyribonucleic acid [ctDNA], digital droplet polymerase chain reaction [ddPCR], and pharmacogenomic analysis), both collected at or after the diagnosis of locally advanced or metastatic NSCLC, must be provided.
- •Any toxicities from prior anticancer therapy must have resolved to common terminology criteria for adverse events (CTCAE) Grade 1 or baseline level.
- •Participant must have at least 1 measurable lesion, according to response evaluation criteria in solid tumors (RECIST) v1.1 that has not been previously irradiated. Measurable lesions should not have been biopsied during screening, but if only 1 non-irradiated measurable lesion exists, it may undergo a diagnostic biopsy and be acceptable as a target lesion, provided the baseline tumor assessment scans are performed at least 14 days after the biopsy.
排除标准
- •Participant has received any prior systemic treatment for locally advanced or metastatic disease (adjuvant or neoadjuvant therapy is allowed, if administered more than 12 months prior to the development of locally advanced or metastatic disease).
- •Participant has an active or past medical history of leptomeningeal disease.
- •Participant has spinal cord compression that has not been definitively treated with surgery or radiation or requires steroid treatment within 2 weeks prior to randomization.
- •Participant has an active or past medical history of interstitial lung disease (ILD)/pneumonitis, including drug-induced or radiation ILD/pneumonitis.
- •Participant has known allergy, hypersensitivity, or intolerance to the excipients used in formulation of amivantamab, lazertinib, or osimertinib, or any contraindication to the use of osimertinib.
- •Participant has symptomatic brain metastases. A participant with asymptomatic or previously treated and stable brain metastases may participate in this study.
结局指标
主要结局
Progression-Free Survival according to RECIST v1.1 by Blinded Independent Central Review
时间窗: Up to approximately 42 months
次要结局
- Overall Survival(Up to approximately 60 months)
- Incidence and Severity of Adverse Events(Up to approximately 60 months)
- Number of Participants with Anti-Amivantamab Antibodies(Up to approximately 42 months)
- Number of Participants with Vital Signs Abnormalities(Up to approximately 60 months)
- Plasma Concentration of Lazertinib(Up to approximately 42 months)
- Objective Response Rate(Up to approximately 42 months)
- Duration of Response(Up to approximately 42 months)
- Time to Symptomatic Progression(Up to approximately 42 months)
- Intracranial PFS(Up to approximately 42 months)
- Number of Participants with Clinical Laboratory Abnormalities(Up to approximately 60 months)
- Number of Participants with Physical Examination Abnormalities(Up to approximately 60 months)
- Change from Baseline in Non-Small Cell Lung Cancer -Symptom Assessment Questionnaire (NCSLC-SAQ)(Baseline Up to approximately 42 months)
- Change from Baseline in European Organization of Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)(Baseline Up to approximately 42 months)
- Progression-Free Survival After First Subsequent Therapy(Up to approximately 42 months)
- Serum Concentration of Amivantamab(Up to approximately 42 months)
研究者
研究点 (5)
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