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这是一项关于非小细胞肺癌的II 期研究，登记的药物或干预包括Amivantamab；Lazertinib；Carboplatin；Pemetrexed；Direct Oral Anticoagulant (DOAC)；Low Molecular Weight Heparin (LMWH)，当前状态为招募中。登记地点显示中国保定、长春、成都、重庆等城市有研究中心记录。是否仍有名额以及是否值得进一步询问，需要向研究中心确认。
药物或干预
Amivantamab；Lazertinib；Carboplatin；Pemetrexed；Direct Oral Anticoagulant (DOAC)；Low Molecular Weight Heparin (LMWH) · II 期
登记条件中文摘要
年龄范围：18岁及以上
登记的基本范围为不限性别，年龄18岁及以上；以下仅摘录7项专业入选条件，需结合英文原文并由研究团队确认。
登记记录列出7项主要排除条件，具体医学含义需结合英文原文并由研究团队确认。
中国哪些地方有记录
以下地点来自登记信息，不代表此刻仍有名额；请向研究中心确认最新情况。
- Affiliated Hospital of Hebei University · 保定
- Jilin cancer hospital · 长春
- Sichuan Cancer Hospital · 成都
- West China Hospital Sichuan University · 成都
- The First Affiliated Hospital of PLA Army Medical University · 重庆
- The First Affiliated Hospital Sun Yat sen University · 广州
- The First Affiliated Hospital Zhejiang University College of Medicine · 杭州
- Sir Run Run Shaw Hospital Zhejiang University School of Medicine · 杭州
- Harbin medical university cancer hospital · 哈尔滨
- Huizhou Municipal Central Hospital · 惠州
- Liuzhou people's Hospital · 柳州
- Fudan University Shanghai Cancer Center · 上海
- Tianjin Medical University General Hospital · 天津
- The First Affiliated Hospital of Wenzhou Medical University · 温州
- Union Hospital Tongji Medical College of Huazhong University of Science and Technology · 武汉
- Hospital of Jiangnan University · 无锡
- The First Affiliated Hospital of Xian Jiaotong University · 西安
- Yantai Yuhuangding Hospital · 烟台
入选条件原文摘录
以下为摘录，请打开原始登记查看完整入排标准。
- * Participant must have histologically or cytologically confirmed, locally advanced or metastatic, non-small cell lung cancer (NSCLC) that is not amenable to curative therapy including surgical resection or chemoradiation. Additional Cohort specific disease requirements include: Cohorts 1, 3, 3b, 5, 6 and 7: epidermal growth factor receptor (EGFR) exon 19 deletion (Exon19del) or Exon 21 L858R mutation; Cohort 2: EGFR Exon 20ins mutation. Cohorts 1,5,and6: Participant should not have received any prior systemic therapy for locally advanced or metastatic NSCLC. Cohort 2: Participant should not have received any prior systemic therapy for locally advanced or metastatic NSCLC. Cohorts 3and3b: Participant must have progressed on or after osimertinib monotherapy as the most recent line of treatment. Osimertinib must have been administered as either the first-line treatment for locally advanced or metastatic disease or in the second-line setting after prior treatment with first- or second-generation EGFR tyrosine kinase inhibitor (TKI) as a monotherapy. Cohort 4: Participants need to currently be on an amivantamab IV Q2W regimen (1,050 mg or 1,400 mg depending on weight) for at least 8 weeks, as part of standard of care, an expanded access program, or as a rollover from a long-term extension, without any amivantamab dose reduction. Cohort 7: Participants must have progressed on or after the combination of amivantamab and lazertinib as the most recent line of treatment. The combination of amivantamab and lazertinib must have been administered as the first-line treatment for locally advanced or metastatic disease. Cohort 2, 3, 3b, and 7 only: Squamous NSCLC are excluded. EGFR mutation must have been identified as determined by Food and Drug Administration (FDA) approved or other validated test of either circulating tumor deoxyribonucleic acid (ctDNA) or tumor tissue 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). A copy of the initial test report documenting the EGFR mutation must be included in the participant records and a deidentified copy must also be submitted to the sponsor
- * All cohorts except Cohort 4: Participants must have at least 1 measurable lesion, according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. If the only target lesion has been previously irradiated, it must show signs of disease progression since radiation was completed If only 1 non-irradiated measurable lesion exists, which undergoes a biopsy and is acceptable as a target lesion, the baseline tumor assessment scans should be performed at least 14 days after the biopsy
- * May have a prior or concurrent second malignancy (other than the disease under study) which natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment(s)
- * Have adequate organ (renal, hepatic, hematological, coagulation and cardiac) functions
- * Participant must have eastern cooperative oncology group (ECOG) status of 0 or 1
- * Cohort 6: Must be eligible for, and agree to comply with, the use of prophylactic anticoagulation with a direct oral anticoagulant or a low molecular weight heparin during the first 4 months of study treatment
- * A participant must agree not to donate eggs (ova, oocytes) or freeze for future use for the purposes of assisted reproduction during the study and for a period of 6 months after receiving the last dose of study treatment. Participants with child bearing potential should consider preservation of eggs prior to study treatment as anti-cancer treatments may impair fertility
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请继续确认中心是否启动、疾病分型、既往治疗、检查费用和知情同意安排。
查看登记信息
登记号：NCT05498428；登记信息更新于 2026-09-28；本站同步于 2026-10-08。