Camrelizumab With Chemotherapy in Adults With Medically Inoperable Early Stage NSCLC
A Pilot Study of Camrelizumab With Chemotherapy in Adults With Medically Inoperable Early Stage Non-Small Cell Lung Cancer (NSCLC)
研究概览
详细说明
This trial will evaluate the safety and efficacy of camrelizumab in combination with chemotherapy, followed by camrelizumab alone after 4-6 cycles of combination in participants with medically inoperable stage I or IIA non-small cell lung cancer (NSCLC). The primary objective of this pilot study is to determine the Camrelizumab plus chemotherapy improves progression-free survival (PFS) . All the efficacy and safety are assessed by investigator : 1) response rate (ORR), 2) disease control rate (DCR); 3) overall survival (OS), 4) PFS rate of 1-year, 2-year, and 5-year; and 5) OS rate of 1-year, 2-year, and 5-year.
Explore objective is potential biomarker associated with efficacy.
研究类型
注册 (预期的)
阶段
- 阶段2
联系人和位置
学习联系方式
- 姓名:Changli Wang, PhD
- 电话号码:6417 86-22-23340123
- 邮箱:wangchangli@medmail.com.cn
研究联系人备份
- 姓名:Lianming Zhang, PhD
- 电话号码:6417 86-22-23340123
学习地点
-
-
-
Tianjin、中国、300060
- 招聘中
- Tianjin Medical University Cancer Institute and Hospital
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patients aged ≥18 years, male and female are not limited;
- Patients with ECOG score of 0-1;
- Life expectancy ≥12 weeks;
- Patients must have histologically- or cytologically-documented NSCLC (according to 2015 WHO Classification);
- Patients with stage I - IIA (T1-T2bN0M0, tumor size ≤ 50mm) confirmed by radiographic;and medical inoperable, unable to undergo thoracic surgery, or refusing to surgery (according to the eighth edition of TNM staging);
- Patients with measurable target lesions according to the RECIST 1.1 standard;
- Patients have not received prior treatment for their NSCLC, including radiotherapy, chemotherapy, surgery and target drugs;
- Can provide tumor tissue;
- Adequate organ and marrow function;
- Fertile female were required to have a serum or urine pregnancy test within 72 hours before the start dose of study medication and the result has been negative;If female of childbearing potential, is willing to use adequate contraception for the course of the study through 90 days after the last dose of study medication; if male with a female partner(s) of child-bearing potential, must agree to use adequate contraception starting with the first dose of study medication through 90 days after the last dose of study medication;
- Provision of signed ICF.
Exclusion Criteria:
- Known any distance metastases;
- Patients with known EGFR gene mutation or ALK fusion mutation;
- Patients with any active autoimmune disease or history of autoimmune disease;
- Patients with innate or acquired immune deficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B, hepatitis C or co-infection with hepatitis B and hepatitis C;
- Subjects requiring systemic treatment with corticosteroids (> 10 mg / day of prednisone or its equivalent) or other immunosuppressants within 14 days prior to the first administration;
- Patient must not have received a live, attenuated vaccine within 4 weeks prior to the first administration;
- Any therapy for NSCLC treatment;
- Patients with other malignant tumors in the past 5 years;
- Patients with previous or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiologic pneumonia, drug-induced pneumonia and active pneumonia confirmed by imaging;
- Patients with cardiac insufficiency;
- Routine urine test indicated that urine protein was >= (+ +), or 24-hour urine protein was >= 1g, or severe liver and kidney dysfunction;
- Patients with severe infection or fever of unknown origin >38.5 ℃ within 4 weeks prior to the first administration;
- Patients with known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
- Pregnant or lactating women; those with fertility who are unwilling or unable to take effective contraceptive measures;
- Known allergies, hypersensitivity, or intolerance to camrelizumab or its excipients or to pemetrexed or to nab-paclitaxel;
- Any condition that, in the opinion of the investigator, would interfere with evaluation of the study drug or interpretation of patient safety or study results,or the patient is unlikely to comply with study procedures, restrictions, and requirements.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Camrelizumab combined with chemotherapy
Participants receive camrelizumab 200 mg by intravenous (IV) infusion prior to chemotherapy on Day 1 of each 21-day cycle for up to 18 cycles PLUS Investigator's choice of chemotherapy. Interventions: Biological: Camrelizumab |
化疗
其他名称:
PD-1
其他名称:
化学疗法
其他名称:
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Progression-free Survival (PFS)
大体时间:up to approximately 3 years
|
PFS is determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).
|
up to approximately 3 years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Overall Survival (OS)
大体时间:up to approximately 5 years
|
OS is defined as the first date of treatment to date of death from any causes.
|
up to approximately 5 years
|
|
Objective response rate (ORR)
大体时间:up to approximately 1 years
|
ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 by investigator.
|
up to approximately 1 years
|
|
Disease Control Rate (DCR)
大体时间:up to approximately 3 years
|
DCR is defined as the percentage of patients who have achieved complete response and partial response per RECIST 1.1 by investigator..
|
up to approximately 3 years
|
|
Adverse Events (AEs)
大体时间:up to 18 months
|
The number of participants experiencing an AE will be assessed.
|
up to 18 months
|
|
12 个月时的 PFS (PFS12)
大体时间:最长 12 个月
|
PFS 将使用 Kaplan-Meier 产品限制方法计算。
|
最长 12 个月
|
|
PFS at 24 months (PFS24)
大体时间:up to maximum 24 months
|
PFS will be calculated using Kaplan-Meier product limit methods.
|
up to maximum 24 months
|
|
PFS at 5 years
大体时间:up to maximum 5 years
|
PFS will be calculated using Kaplan-Meier product limit methods.
|
up to maximum 5 years
|
|
12 个月时的操作系统 (OS12)
大体时间:最长 12 个月
|
OS 将使用 Kaplan-Meier 产品限制方法计算。
|
最长 12 个月
|
|
24 个月时的操作系统 (OS24)
大体时间:最长 24 个月
|
OS 将使用 Kaplan-Meier 产品限制方法计算。
|
最长 24 个月
|
|
OS at 5 years
大体时间:up to maximum 5 years
|
OS will be calculated using Kaplan-Meier product limit methods.
|
up to maximum 5 years
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.