NCT05940532招募中2 期
A Single-arm Phase 2 Study of Sugemalimab and Chemotherapy as Induction Therapy in Unresectable and Stage III Non-small Cell Lung Cancer (NSCLC)
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
- 41
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
The goal of this phase II, open-label, single-arm study is to evaluate the efficacy and safety of induction immunotherapy and chemotherapy followed by the multidisciplinary team (MDT)-guided radiotherapy or surgery in unresectable, stage III 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
- •1.18 to 75 years old, both male and female;
- •2.ECOG score: 0-1;
- •3.Histopathologically or cytologically confirmed, stage III (AJCC 8th) non-small cell lung cancer;
- •4.Multidisciplinary team (MDT) discussion confirmed unresectable disease but can be treated by curative radiotherapy;
- •5.Measurable lesions available;
- •6.Major organ function is basically normal;
- •7.Estimated survival time is at least 6 months;
- •8.Non-surgically sterile female subjects of childbearing age must have a negative serum HCG test before inclusion.
排除标准
- •Histologically or cytologically confirmed mixed SCLC and NSCLC;
- •Subjects with driver gene mutations(EGFR mutation, ALK fusion, etc.);
- •Previous systemic anti-tumor therapy including immune checkpoint inhibitors for NSCLC;
- •Previous thoracic radiotherapy;
- •Subjects who participated in other clinical trials within 4 weeks or 5 drug half-lives(whichever is shorter) before the first dose;
- •Systemic immunostimulant therapy before the first dose;
- •Systemic immunosuppressive therapy before the first dose or were expected to require systemic immunosuppressive drugs during the study treatment;
- •Subjects with autoimmune diseases;
- •Other malignant tumors other than non-small cell lung cancer within 5 years before screening;
- •Known or suspected interstitial pneumonia;
- •Other moderate to severe lung diseases that may interfere with the detection or treatment of drug-related pulmonary toxicity and seriously affect respiratory function;
- •Severe cardiovascular and cerebrovascular diseases;
- •Clinically significant bleeding symptoms or significant bleeding tendency within 1 month before the first dose;
- •Arteriovenous thrombotic events within 3 months before the first dose;
- •Positive HIV test;
- •Active hepatitis B or C;
- •Evidence of active tuberculosis infection within 1 year before the first dose;
- •Serious infection within 4 weeks before the first dose;
- •History of attenuated live vaccination 28 days before the first dose or expected to receive attenuated live vaccination during the study;
- •Major surgeries other than diagnosis or biopsy within 28 days prior to the first dose;
- •Previous or planned allogeneic bone marrow transplantation or solid organ transplantation;
- •History of severe allergic reactions to other monoclonal antibodies/fusion proteins;
- •Allergic to any component of the randomized treatment regimen;
- •Female subjects who are pregnant, lactating, or planning to get pregnant during the study period;
- •Subjects who have a known history of psychotropic drug abuse, alcoholism, or drug abuse;
- •Presence of other conditions that, in the opinion of the investigator, would make participation in this clinical trial inappropriate.
研究组 & 干预措施
Interventional arm
Experimental
Patients will receive 3 cycles of induction therapy with sugemalimab and chemotherapy before curative local therapy.
干预措施: Sugemalimab and Chemotherapy (Drug)
结局指标
主要结局
ORR
时间窗: From the initiation of the first dose to 3 years
Objective response rate
次要结局
- OS(From the initiation of the first dose to 3 years)
- AEs(From the initiation of the first dose to 90 days after the last dose)
- PFS(From the initiation of the first dose to 3 years)
- iORR(From the initiation of the first dose to 3 years)
- Measurement of Quality of Life with EORTC EQ-5D-5L VAS questionnaire(From the initiation of the first dose to 3 years)
- Measurement of Quality of Life with EORTC QLQ-C30 questionnaire(From the initiation of the first dose to 3 years)
- Measurement of Quality of Life with EORTC QLQ-LC13 questionnaire(From the initiation of the first dose to 3 years)
研究者
研究点 (1)
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