NCT07247227招募中不适用
Sugemalimab Plus Platinum-based Chemotherapy as First-line Therapy for Patients With Locally Advanced and Metastatic Non-small Cell Lung Cancer (NSCLC) in a Real-world Setting: a Single-arm, Multi-center Study
Peking Union Medical College1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2023年10月10日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- rw-PFS
研究概览
简要总结
This single-arm, multi-center study is to evaluate Sugemalimab plus platinum-based chemotherapy as first-line therapy for patients with locally advanced and metastatic NSCLC in a real-world setting.
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
- •Age ≥ 18 years.
- •Patients voluntarily join the study and sign an informed consent form for the study.
- •ECOG PS score 0-3 (patients with PS score 2-3 would be enrolled if due to the tumor disease and anticipated to be improved at investigators' decision).
- •Histologically documented, stage III, IV non-Small Cell Lung Cancer (according to version 8th of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology) and previously untreated systematically(excluding local therapy for local lesions or symptomatic relief, palliative radiotherapy, intervention, intrathecal injection, nerve block, etc.).
- •Patients with stage III NSCLC who are not suitable for surgery at a multidisciplinary discussion or investigators' assessment.
- •Patients with at least one measurable target lesion by CT scan/MRI (RECISTv1.1).
- •Patients with active brain metastases and liver metastases could be enrolled (Concurrent radiotherapy, intervention, dehydration, and other local treatment are permitted).
- •Interstitial pneumonia, drug-induced pneumonia, radiation pneumonitis requiring steroid therapy, or active pneumonia with clinical symptoms of grade 2, can be included after symptomatic treatment until recovery to grade 0-
- •Fertile men and women of childbearing age must agree to take effective contraceptive measures from signing the main informed consent until 180 days after the last dose of the study drug. Women of childbearing potential include premenopausal women and women within 2 years of menopause. Females of childbearing potential must have a negative pregnancy test ≤ 7 days prior to the first dose of study drug.
排除标准
- •All patients carry activating mutations of EGFR, ALK, ROS1, and RET. (No more mutation test needed).
- •Small cell lung cancer (including patients with mixed small cell lung cancer and non-small cell lung cancer).
- •Histopathologically or cytopathologically confirmed non-NSCLC.
- •Any prior treatment of antibody/drug that targets T-cell coregulatory proteins (not limited to CTLA-4 inhibitors or other agents targeting T cells).
- •Any tumor history within the past 5 years prior to the start of treatment in this study (except cured cervical carcinoma in situ, cured basal cell carcinoma, and bladder epithelial tumors with surgical resection alone and at least 5 consecutive years of disease-free survival).
- •Patients with active, unstable systemic disease, active infection, uncontrolled hypertension, heart failure (NYHA class >= II), unstable angina pectoris, acute coronary syndrome, severe arrhythmia, severe liver, kidney, or metabolic diseases, HIV infection.
- •Pregnant or lactating women.
- •Systemic anti-tumor therapy planned within 4 weeks before first-line treatment or during medication after enrollment, including cytotoxic therapy, signal transduction inhibitors, immunotherapy (with the exception of thymosin, lentinan, and other immunomodulator therapy).
- •Major surgical treatment, incisional biopsy, or significant traumatic injury within 28 days before 1st line therapy.
- •Participation in other anti-tumor drug clinical trials within 4 weeks before first-line therapy.
- •Active, known, or suspected autoimmune diseases. Vitiligo and Type I diabetes mellitus with no systemic treatment are allowed. Residual hypothyroidism caused by autoimmune thyroiditis requiring only hormone replacement therapy is allowed.
- •With known mental illness, alcoholism, drug abuse, or other factors which may cause termination of this study, affect the safety of subjects, or collection of data and samples.
研究组 & 干预措施
stage III NSCLC.
Experimental
sugemalimab+platinum-based chemotherapy in stage III NSCLC.
干预措施: Sugemalimab and Chemotherapy (Drug)
stage IV NSCLC.
Experimental
Sugemalimab 1200mg plus 4-6 cycles of platinum-based chemotherapy
干预措施: Sugemalimab and Chemotherapy (Drug)
结局指标
主要结局
rw-PFS
时间窗: From enrollment to the end of treatment at 1 year
rw-PFS, defined as the time from the start of 1st line treatment to tumor progression or death, which occurs first
次要结局
- TTF(From enrollment to the end of treatment at 1 year)
- OS(From enrollment to the end of treatment at 1 year)
- Objective response rate (ORR)(From enrollment to the end of treatment at 1 year)
- DCR(From enrollment to the end of treatment at 1 year)
- DOR(From enrollment to the end of treatment at 1 year)
- Safety, number of participants with treatment-related adverse events (AEs)(From enrollment to the end of treatment at 1 year)
- 12-month, 18-month, and 24-month overall survival (OS) rates(Up to 24 months from treatment initiation (with OS rates assessed at 12, 18, and 24 months))
研究者
Junling Li
professor
Peking Union Medical College
研究点 (1)
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