CTRI/2020/11/029081进行中（未招募）3 期
A Randomized, Open-label Phase 3 Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared with Carboplatin-Pemetrexed, in Patients with EGFR Exon 20ins Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 300
- 试验地点
- 6
- 主要终点
- Progression-Free Survival (PFS) According to RECIST v1.1 as Assessed by Blinded Independent Central Review
研究概览
简要总结
The purpose of this study is to compare the efficacy, as demonstrated by progression-free survival (PFS), in participants treated with amivantamab in combination with chemotherapy, versus chemotherapy alone in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC)
characterized by EGFR Exon 20ins mutations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
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, nonsquamous non-small cell lung cancer (NSCLC) with documented primary epidermal growth factor receptor (EGFR) Exon 20ins activating mutation.
- •Participant must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.
- •Participant must have Eastern Cooperative Oncology Group (ECOG) performance status 0 or
- •Participant must agree to genetic characterization of tumor status through the required pretreatment tumor biopsy (or submission of equivalent archival material), as well as baseline and periodic blood samples for analysis of tumor mutations in the bloodstream.
排除标准
- •Participant has evidence of synchronous NSCLC with an EGFR mutation other than EGFR Exon 20ins.
- •Participant has untreated brain metastases (a participant with definitively, locally treated metastases who is clinically stable, asymptomatic, and off corticosteroid treatment for at least 2 weeks prior to randomization is eligible).
- •Participant has history of spinal cord compression that has not been treated definitively with surgery or radiation.
- •Participant has a medical history of interstitial lung disease (ILD), including drug-induced ILD, or radiation pneumonitis.
- •Participant has a contraindication to the use of carboplatin or pemetrexed (refer to local prescribing information for each agent). Participant has a history of hypersensitivity to, or cannot take, vitamin B12 or folic acid.
结局指标
主要结局
Progression-Free Survival (PFS) According to RECIST v1.1 as Assessed by Blinded Independent Central Review
时间窗: Up to 18 months
次要结局
- Objective Response Rate(Up to 48 months)
- Duration of Response(Up to 48 months)
- Overall Survival(Up to 48 months)
- Time to Subsequent Therapy(Up to 48 months)
- Progression-Free Survival After First Subsequent Therapy(Up to 48 months)
- Time to Symptomatic Progression(Up to 48 months)
- Incidence and Severity of Adverse Events(Up to 48 months)
- Number of Participants with Clinical Laboratory Abnormalities(Up to 48 months)
- Number of Participants with Vital Signs Abnormalities(Up to 48 months)
- Number of Participants with Physical Examination Abnormalities(Up to 48 months)
- Serum Concentration of Amivantamab(Up to 48 months)
- Number of Participants with Anti-Amivantamab Antibodies(Up to 48 months)
- European Organization of Research and Treatment of Cancer Quality of Life Questionnaire Core 30(Up to 48 months)
- Patient Reported Outcomes Measurement Information System-Physical Function(Up to 48 months)
研究者
研究点 (6)
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