AmiCARE: A Clinical Trial on the Outcomes of Comprehensive Enhanced Prophylaxis Management (CEPM) in Chinese Patients With EGFR-Mutated Advanced NSCLC Receiving Amivantamab-Based Regimens
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- The proportion of participants in 3 cohorts reporting improved/stable global health status of QoL score at 3 months
研究概览
简要总结
This study aims to explore the clinical outcomes of Comprehensive Enhanced Preventive Management (CEPM) combined with an amivantamab-containing treatment regimen in Chinese patients with EGFR-mutated advanced NSCLC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Aged at least 18 (or the legal age of consent in the jurisdiction in which the study is taking place) at the time of informed consent.
- •Participants have a confirmed diagnosis of locally advanced or metastatic EGFR-mutated NSCLC (Stage IIIB/C or IV).
- •Participant [and/or their legally authorized representative where applicable] must sign an ICF allowing source data verification in accordance with local requirements and indicating that the participant understands the purpose of and procedures required for the study and is willing to participate in the study.
- •Participants have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to
- •Participants with asymptomatic or previously treated and stable brain metastases may participate in this study. Participants who have completed definitive therapy, are not on steroids, and have a stable clinical status for at least 2 weeks prior to study treatment are allowed.
- •Be eligible for, and agree to comply with, the use of enhanced dermatologic management and enhanced IRR prophylaxis management during the duration of anticancer treatments with amivantamab and lazertinib, or amivantamab with chemotherapy.
- •Cohort 1 (cEGFR 1L):
- •EGFR mutation must be an Ex19del or Ex21 L858R substitution.
- •Participants who plan to receive Amivantamab (IV form) and Lazertinib regimen treatment based on physician's medical judgement.
- •Participant is treatment-naive and not amenable to curative therapy including surgical resection or (chemo)radiation. Adjuvant or neoadjuvant therapy is allowed if last dose administered more than 12 months prior to the development of locally advanced or metastatic disease.
- •Be eligible for, and agree to comply with, the use of prophylactic-dose anticoagulation with a direct oral anticoagulant or a low molecular weight heparin during the first 4 months of anticancer treatment (from Day 1-120) according to Chinese Society of Clinical Oncology (CSCO) guidelines.
- •Cohort 2 (cEGFR 2L):
- •EGFR mutation must be an Ex19del or Ex21 L858R substitution.
- •Participants who plan to receive Amivantamab (IV form) and Chemotherapy regimen treatment based on physician's medical judgement.
- •Participants must have progressed on or after prior therapy including an EGFR TKI for advanced or metastatic NSCLC. Amivantamab and chemotherapy will be received as a second-line treatment.
- •Cohort 3 (EGFR Ex20ins 1L):
- •EGFR mutation must be an EGFR Ex20ins.
- •Participants who plan to receive Amivantamab (IV form) and Chemotherapy regimen treatment based on physician's medical judgement.
- •Participant is treatment-naive and not amenable to curative therapy including surgical resection or (chemo)radiation. Adjuvant or neoadjuvant therapy for is allowed if last dose administered more than 12 months prior to the development of locally advanced or metastatic disease.
排除标准
- •Pregnancy or breastfeeding.
- •Is currently enrolled in an interventional clinical study.
- •Any condition for which, at the investigator's discretion, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
研究组 & 干预措施
Cohort 3 (EGFR Ex 20ins 1L)
Participants will receive enhanced dermatologic management and enhanced IRR prophylaxis management
干预措施: Enhanced IRR Prophylaxis (Combination Product)
Cohort 1 (cEGFR 1L)
Participants will receive enhanced dermatologic management, enhanced IRR and VTE prophylaxis management
干预措施: Enhanced dermatologic management (Combination Product)
Cohort 1 (cEGFR 1L)
Participants will receive enhanced dermatologic management, enhanced IRR and VTE prophylaxis management
干预措施: Enhanced IRR Prophylaxis (Combination Product)
Cohort 1 (cEGFR 1L)
Participants will receive enhanced dermatologic management, enhanced IRR and VTE prophylaxis management
干预措施: Enhanced VTE Prophylaxis (Cohort 1 only) (Combination Product)
Cohort 2 (cEGFR 2L)
Participants will receive enhanced dermatologic management and enhanced IRR prophylaxis management
干预措施: Enhanced dermatologic management (Combination Product)
Cohort 2 (cEGFR 2L)
Participants will receive enhanced dermatologic management and enhanced IRR prophylaxis management
干预措施: Enhanced IRR Prophylaxis (Combination Product)
Cohort 3 (EGFR Ex 20ins 1L)
Participants will receive enhanced dermatologic management and enhanced IRR prophylaxis management
干预措施: Enhanced dermatologic management (Combination Product)
结局指标
主要结局
The proportion of participants in 3 cohorts reporting improved/stable global health status of QoL score at 3 months
时间窗: At 3 months
次要结局
- The proportion of participants in 3 cohorts reporting improved/stable global health status of QoL at 6 months(At 6 months)
- Safety in Subjects receiving Amivantamab-based regimens(12 months)
- Overall response rate (ORR)(12 months)
- Progression-free survival (PFS)(12 Months)
- 12-month PFS rate(12 months)
- Time to treatment failure (TTF)(12 months)
- Duration of response (DOR)(12 months)
研究者
Ren Shengxiang
Chief of Medical Oncology
Shanghai Pulmonary Hospital, Shanghai, China