NCT04338620进行中（未招募）2 期
An Explorative Study on Camrelizumab Combined With Albumin-bound Paclitaxel and Platinum in Neoadjuvant Treatment of Resectable Non-small-cell Lung Carcinoma
Tang-Du Hospital1 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2020年4月7日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- pathological complete response (pCR)
研究概览
简要总结
Explorative study, which evaluates the effect of Camrelizumab combined with albumin-bound paclitaxel and platinum in neoadjuvant treatment of resectable non-small-cell lung carcinoma.
详细描述
This is a multicenter, randomized, open parallel controlled trial to evaluate the efficacy and safety of camrelizumab combined with albumin-bound paclitaxel and platinum versus albumin-bound paclitaxel combined with platinum in resectable stage IIIA -IIIB NSCLC (IIIB is limited toT3N2).
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age :18 Years to 70 Years (Adult, Older Adult)
- •ECOG physical score status of 0 or 1 points;
- •expected survival time ≥ 12 weeks;
- •Pathological diagnosis with StageIIIA-IIIB NSCLC;
- •According to the eighth edition of the AJCC/UICC TNM staging system, patients was pathological diagnosed with Stage III-N2 clinically resectable NSCLC.
- •Patients with at least one evaluable or measurable lesions as per RECIST version 1.1 （CT scan length and diameter of tumor lesion≥10mm，CT scan of lymph node lesion was short diameter≥15mm；）
- •Patients were newly diagnosed with non-small cell lung cancer, without radiotherapy, chemotherapy, surgery or molecule-targeted treatment.
- •Patients must have enough cardiopulmonary function for the expected pulmonary resections for lung cancer.
- •The main organ function meets the following criteria:1) blood routine:a. ANC ≥ 1.5×109/L; b. PLT ≥ 100×109/L; c. HB ≥ 90 g/L; 2) Blood biochemistry:TBIL ≤ 1.5×ULN;ALT、AST≤ 2.5×ULN;sCr≤1.5×ULN; 3) Blood coagulation: INR≤1.5×ULN and APTT≤1.5×ULN，endogenous creatinine clearance rate≥50ml/min(Cockcroft-Gault formula);
- •Pregnancy test (serum or urine) has to be performed for woman of childbearing age within 7 days before enrolment and the test result must be negative. They shall take appropriate methods for contraception during the study until the 3 months post the last administration of study drug. For men, (previous surgical sterilization accepted), shall agree to take appropriate methods of contraception during the study until the 3 months post the last administration of study drug;
- •Patient has to voluntarily join the study and sign the Informed Consent Form for the study.
排除标准
- •The subject must be excluded from participating in the trial if the subject:
- •Patients with brain metastasis
- •Patients with autoimmune disease, or a history of autoimmune disease including but not limited to the following: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism which can be included after hormone replacement therapy; Subjects with childhood asthma have been completely alleviated and without any intervention or vitiligo in adulthood can be included.
- •Subjects who need medical intervention with bronchodilators cannot be included.
- •Subjects with congenital or acquired immunodeficiency such as HIV infection, active hepatitis B (HBV DNA ≥ 2000 IU/mL), hepatitis C (hepatitis C antibody is positive);
- •Subjects with a condition requiring other immunosuppressive medications before 14 days of study drug administration firstly, not including inhaled corticosteroids or physiological doses of systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents).
- •Has received a live vaccine within 4 weeks of planned start of study therapy.
- •Other malignancies have been diagnosed within 3 years prior to the first use of the study drug;
- •Patients with a current or history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiologic pneumonia, drug-induced pneumonia and severe impairment of lung function.
- •Patients with hypertension that is difficult to control (systolic blood pressure ≥140 mmHg and diastolic blood pressure ≥90 mmHg);
- •patients with myocardial ischemia and myocardial infarction above class II (including QT interval prolongation, for man ≥ 450 ms, for woman ≥ 470 ms);
- •Severe infection within 4 weeks before the first administration (such as intravenous drip of antibiotics, antifungal drugs or antiviral drugs), or fever of unknown origin (> 38.5 ℃) within 4 weeks before the first administration.
- •allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation.
- •Pregnant or nursing women;
- •Patients with a history of hypersensitivity to any of the study drugs, similar drugs, or excipients.
- •Participated in other clinical trials within 4 weeks;
- •Patients with the history of drug abused or alcohol.
- •The investigator believes that there are any conditions that may damage the subject or result in the subject being unable to meet or perform the research request;
研究组 & 干预措施
A: Experimental Group
Experimental
Participants receive totally 3 cycles of camrelizumab combined with albumin-bound paclitaxel and Cisplatin/carboplatin/Nedaplatin treatment during preoperative period, every 3 weeks for up to 3 cycles.
干预措施: camrelizumab、albumin-bound paclitaxel and platinum (Drug)
B: Control group
Active Comparator
Participants receive totally 3 cycles of albumin-bound paclitaxel combined with Cisplatin/carboplatin/Nedaplatin treatment during preoperative period, every 3 weeks for up to 3 cycles.
干预措施: albumin-bound paclitaxel and platinum (Drug)
结局指标
主要结局
pathological complete response (pCR)
时间窗: The day of the surgery
no residual tumor cells in the surgically resected tumor specimen and all sampled regional lymph nodes after neoadjuvant treatment.
次要结局
- main pathology rate (MPR)(The day of the surgery)
- Objective Response Rate (ORR)(pre-operation)
- Event-free Survival （EFS）(Event-free survival (EFS): defined as the time from the randomization until the date of first documented progression or recurrence or date of death from any cause, whichever came first, assessed up to 100 months)
- Assess adverse events(90 days)
研究者
研究点 (1)
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