NCT05296278招募中2 期
Efficacy and Biomarker Explanation of IBI-323 Combined With Bevacizumab Plus Platinum Based Chemotherapy on ALK-Rearranged Non-Small Cell Lung Cancer Who Failed From First Line Alectinib
Hunan Province Tumor Hospital1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2023年12月25日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
This study aimed to explore the efficacy and biomarker explanation of IBI-323 combined with bevacizumab plus platinum based chemotherapy on ALK-rearranged non-small cell lung cancer who failed from first line Alectinib.
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
- •Sign written informed consent before implementing any trial-related procedures;
- •Age ≥18 years old and ≤75 years old.
- •No limit on the gender.
- •Patients diagnosed with Lung Adenocarcinoma ALK-Rearranged Stage IIIA-IV by pathology.
- •Patients who failed from first line Alectinib with stable brain metastasis included (Radiotherapy treated Oligo-metastasis).
- •According to the Solid Tumor Efficacy Evaluation Criteria (RECIST V1.1), at least one lesion can be measured on imaging. Lesions located in the field of previous radiation therapy may be considered measurable if progression is demonstrated.
- •ECOG score 0-1 points.
排除标准
- •Patients with contraindication of chemotherapy Pregnant or breast feeding women.
- •Participate in another interventional clinical study, unless participating in an observational (non-interventional) clinical study or in the survival follow-up phase of an interventional study.
- •Participants are known to have had previous severe allergic reactions to other monoclonal antibodies or to any of the components of the IBI323 preparation, and severe allergies to bevacizumab, pemetrexed, cisplatin, and carboplatin.
- •Previous systematic anti-tumor therapy for advanced non-squamous NSCLC other than ALK-TKI (including cytotoxic chemotherapy in combination with radiotherapy).
- •Previous use of anti-PD-1 anti-PD-L1 anti-programmed death receptor ligand 2(PD-L2) or anti-cytotoxic T-lymphocyte-associated antigen 4(CTLA-4) drugs or any other drugs that act on T-cell co-stimulation or checkpoint pathways (such as OX40 CD137 LAG3, etc.).
- •Radical radiation therapy within 28 days prior to the first dose, or palliative radiation therapy within 14 days prior to the first dose.
- •Received ALK-TKI treatment within 2 weeks prior to the first administration of the study drug
研究组 & 干预措施
Cohort A
Experimental
patients with only 3'ALK confirmed by NGS
干预措施: IBI-323 combined with bevacizumab plus Platinum (Drug)
Cohort B
Experimental
patients with 3'ALK with retention of 5'ALK
干预措施: IBI-323 combined with bevacizumab plus Platinum (Drug)
结局指标
主要结局
ORR
时间窗: 1 year
Defined as the proportion of subjects in complete remission (CR) and partial remission (PR) to the total subjects
次要结局
- OS(1 year)
- DCR(1 year)
研究者
Yongchang Zhang
Director, Head of Medical Oncology, Principal Investigator, Clinical Professor
Hunan Province Tumor Hospital
研究点 (1)
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