NCT05243355招募中2 期
A Prospective, Single-arm, Phase II Study of Envafolimab Combined With Chemotherapy and Recombinant Human Endostatin in the First-line Treatment of Advanced (Stage IIIB-IV) Squamous Non-small Cell Lung Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- 1 year PFS rate
研究概览
简要总结
This is a prospective, single arm, multicenter phase II study aimed at evaluating the efficacy and safety of Envafolimab combined with standard platinum containing dual drug chemotherapy and Recombinant Human Endostatin in patients with advanced (stage IIIB-IV) squamous non-small cell lung cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent；
- •Aged 18-75 years old；
- •Histologically or cytologically confirmed, locally advanced (Stage IIIB/C) not amenable to curative surgery or radiotherapy, or metastatic/recurrent (Stage IV) squamous NSCLC according to American Joint Committee on Cancer, 8th Edition；
- •At least 1 measurable lesion as defined by RECIST v1.1；
- •ECOG performance status 0-1；
- •No systematic antitumor treatment for advanced / metastatic diseases has been received in the past；
- •Life expectancy sup 3 months；
- •Adequate organ function；
- •For female subjects of childbearing age, urine or serum pregnancy test shall be conducted 3 days before receiving the first study drug administration, and the result is negative；
- •The subject and the subject's sexual partner need to use a medically approved contraceptive measure during the study treatment period and within 6 months after the end of the study treatment period.
排除标准
- •Histology was non squamous cell NSCLC. Mixed cell types must distinguish the dominant cell morphology (squamous cell carcinoma components > 50% can be included in the group); If there are small cell carcinoma, neuroendocrine carcinoma and sarcoma, they can not be included in the group;
- •EGFR sensitive mutations or ALK rearrangements;
- •Imaging (CT or MRI) showed that the tumor invaded large blood vessels or it was judged that the tumor was very likely to invade important blood vessels and cause fatal bleeding during the follow-up study;
- •Concurrent participation in another clinical trial;
- •Have previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs that stimulate or co inhibit T cell receptors (e.g., CTLA-4, OX-40, CD137);
- •Received Chinese patent medicine with anti-tumor indications or drugs with immunomodulatory effect (thymosin, interferon, interleukin, etc.) within 2 weeks, or major surgical treatment within 3 weeks before the first administration;
- •There are active hemoptysis, active diverticulitis, abdominal abscess, gastrointestinal obstruction and peritoneal metastasis that need clinical intervention;
- •Grade III-IV congestive heart failure (New York Heart Association classification), poorly controlled and clinically significant arrhythmia;
- •Any arterial thrombosis, embolism or ischemia, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack, occurred within 6 months before enrollment;
- •Known allergic reactions to PD-1/L1 monoclonal antibodies, taxanes, cisplatin or carboplatin, recombinant human endostatin active ingredients and or any excipients;
- •Patients requiring long-term systemic use of corticosteroids;
- •Symptomatic central nervous metastasis;
- •Active infection requiring treatment or systemic anti infective drugs used within one week before the first administration;
- •Not fully recovered from toxicity and/or complications caused by any intervention before starting treatment (i.e. ≤ grade 1 or reaching baseline, excluding fatigue or hair loss);
- •Known HIV infection;
- •Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number detected greaterthan the upper limit of normal value in the laboratory of the research center);
- •Active HCV infected;
- •Live vaccine was administered within 30 days before the first administration;
- •Pregnant or lactating women;
- •Medical history or disease evidence, abnormal treatment or laboratory test values that may interfere with the test results, prevent the subjects from participating in the whole study, or other situations that the researchers believe are not suitable for inclusion.
研究组 & 干预措施
"Envafolimab" and "Chemotherapy" and "Recombinant Human Endostatin"
Experimental
Envafolimab: 300 mg，D1，Q3W, until PD or intolerable toxicity. Paclitaxel / NAB-Paclitaxel, 175 / 260mg / m2, D1, Q3w. Cisplatin: 75mg / m2, 1-3 days, or carboplatin: AUC 5, D1, Q3w, 4-6 cycles. Recombinant Human Endostatin：210mg，CIV 72h，d1-3，Q3W，4-6 cycles in total.
干预措施: "Envafolimab" and "Chemotherapy" and "Recombinant Human Endostatin" (Drug)
结局指标
主要结局
1 year PFS rate
时间窗: 12 months after the last subject participating in
12-month progression free survival in ITT population
次要结局
- ORR(24 months after the last subject participating in)
- DOR(24 months after the last subject participating in)
- PFS(24 months after the last subject participating in)
- OS(24 months after the last subject participating in)
研究者
研究点 (2)
Loading locations...
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