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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HLX43 DOSE 1 (2.0 mg/kg)；HLX43 DOSE 2 (2.5 mg/kg)，当前状态为招募中。登记地点显示中国北京有研究中心记录。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
HLX43 DOSE 1 (2.0 mg/kg)；HLX43 DOSE 2 (2.5 mg/kg) · 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8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8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。
- National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College · 北京
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。
- * Have a full understanding of the study content, process, and possible adverse reactions before the study, and sign the informed consent form (ICF); voluntarily participate in the study; be able to complete the study as per protocol requirements;
- * Aged ≥ 18 years at the time of signing the ICF, male or female;
- * Histologically or cytologically confirmed, locally advanced (stage IIIB/IIIC) or metastatic (stage IV) NSCLC not suitable for radical treatment (complete surgical resection, concurrent/sequential radio-chemotherapy) according to the Union for International Cancer Control and the American Joint Committee on Cancer (AJCC) TNM staging system (8th edition), and should meet the following criteria:
- 1. Subjects without actionable genomic alterations (AGAs):
- Subjects with non-squamous NSCLC must have documented negative test results for EGFR and ALK alterations. If no prior test results for EGFR and ALK are available, subjects must undergo EGFR and ALK testing at the study site. For subjects with squamous NSCLC, EGFR and/or ALK testing is not required prior to enrollment if their status is unknown;
- No other known actionable genomic alterations, such as ROS1, NTRK, BRAF, MET exon 14 skipping, and RET;
- Prior standard treatment failure of ≥ 1 line, including at least anti-PD-(L)1 antibody and platinum-based chemotherapy;
- 2. Subjects with AGAs:
联系前需要确认
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：NCT06907615；登记信息更新于 2026-10-01；本站同步于 2026-10-08，中国中心当前名额未经人工确认。