A Single-arm, Sequential Study Assessing the Efficacy and Safety of SMET12 and Toripalimab Combined Chemotherapy in Patients With EGFR Positive Advanced Non-small Cell Lung Cancer (NSCLC) : First-line Treatment or Failed From First-line Immune Checkpoint Inhibitor Treatment.
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- incidence of adverse events
研究概览
简要总结
This is a single-arm, sequential study assessing the efficacy and safety of SMET12 and Toripalimab combined chemotherapy in patients with EGFR positive advanced non-small cell lung cancer (NSCLC) : first-line treatment or failed from first-line immune checkpoint inhibitor treatment.The primary objective is to evaluate the anti-tumor activity and safety of SMET12 and Toripalimab combined chemotherapy in patients with EGFR positive advanced NSCLC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Has fully understood and voluntarily signed an informed consent form for this study , willing and able to comply with study procedures.
- •Age ≥ 18 years.
- •Histologically confirmed EGFR positive (immunohistochemistry ≥ [+]) advanced NSCLC ,including: (1) Cohort A: Treatment-naïve subjects; (2) Cohort B: Subjects resistant to first-line treatment contain immune checkpoint inhibitors (stability period > 3 months).
- •At least one measurable lesion via RECIST v1.1 criteria
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or
- •Expected survival ≥ 3 months.
- •Adequate organ function .
排除标准
- •Driver gene-positive (EGFR, ALK, ROS1) .
- •history of dual primary malignancies within the past 5 years.
- •active autoimmune diseases or a history of autoimmune disorders requiring systemic corticosteroid therapy.
- •systemic infections requiring systemic treatment.
- •known central nervous system metastases or other central nervous system diseases or abnormalities deemed unsuitable for inclusion in this study by the investigator.
- •Fertile individuals unable to maintain effective contraception during the trial.
- •Subjects in Cohort B who have received prior docetaxel treatment.
- •Subjects in Cohort B who experienced Grade 3 or higher immune-related adverse events during first-line treatment with immune checkpoint inhibitors.
- •Individuals deemed unsuitable for participation in this clinical trial by the investigator for various reasons .
研究组 & 干预措施
Treatment-naïve subjects with EGFR positive advanced Lung Adenocarcinoma
toripalimab：3mg/kg， Q2W； SMET12：60μg，Q2W； Pemetrexed Disodium 500mg/m2 d+Carboplatin AUV＝5 d1 Q3W，administered for 2~4 cycles
干预措施: SMET12 (Drug)
Treatment-naïve subjects with EGFR positive advanced Lung Squamous Cell Carcinoma
toripalimab：3mg/kg， Q2W； SMET12：60μg，Q2W； paclitaxel 100mg/m2 d1，d8，d15+cisplatin 75mg/m2 d1 Q3W， administered for 2~4 cycles
干预措施: SMET12 (Drug)
Subjects resistant to first-line treatment contain immune checkpoint inhibitors
toripalimab：3mg/kg， Q2W； SMET12：60μg，Q2W； Docetaxel 60-75 mg/m2 d1Q3W，administered for 2~4 cycles
干预措施: SMET12 (Drug)
结局指标
主要结局
incidence of adverse events
时间窗: 1 year
Adverse events incidence refers to the frequency of adverse events
rate of adverse events
时间窗: 1 year
All adverse events will also be rated based on the NCI CTCAE version 5.0.
Laboratory aberrations
时间窗: 1 year
Laboratory outliers refer to measurement results that significantly deviate from the normal reference range in laboratory testing.
次要结局
- disease control rate(1 year)
- Progression-free survival(1 year)
- DOR（ Duration of Response）(1 year)