NCT06357598招募中4 期
Preoperative Neoadjuvant Immunotherapy Combined With Chemotherapy for Newly Diagnosed Stage Ⅲ Unresectable Non-small Cell Lung Cancer: a Open-label, Single-arm Prospective Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- R0 Resection Rate
研究概览
简要总结
Explorative study, which evaluates the effect of Tislelizumab combined with chemotherapy in neoadjuvant treatment of stage Ⅲ unresectable non-small-cell lung carcinoma.
详细描述
This is a open-label, single-arm prospective clinical trial to evaluate the efficacy and safety of Tislelizumab combined with chemotherapy in neoadjuvant treatment of newly diagnosed stage Ⅲ unresectable 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
- •Age :18 Years to 75 Years;
- •ECOG physical score status of 0 or 1 points;
- •Expected survival time ≥ 6 months;
- •According to the eighth edition of the AJCC/UICC TNM staging system, patients were pathological diagnosed with Stage III NSCLC and had one of the following conditions: 1) A complete resection (R0) would not be possible, based on evaluation within a multidisciplinary team, including an experienced thoracic surgeon; 2) Multiple ipsilateral mediastinal lymph nodes metastasized into large masses or multistation metastases (IIIA: T1-2N2 or IIIB: T3-4N2); 3) Contralateral hilar or mediastinal lymph nodes, or ipsilateral or contralateral scalene or supraclavicular lymph nodes metastasis (IIIB: T1-2N3; IIIC: T3-4N3); 4) The lesion invaded the heart, aorta, or esophagus (IIIA: T4N0-1).
- •EGFR mutation or ALK mutation was negative;
- •Patients with at least one evaluable or measurable lesions as per RECIST version 1.1;
- •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≥45ml/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
- •Patients with autoimmune disease, or a history of autoimmune disease within 2 years prior to the first use of the study drug 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 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 7 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 5 years prior to the first use of the study drug (excluding skin basal cell carcinoma that has been cured, skin squamous cell carcinoma, and / or carcinoma in situ that has undergone radical resection);
- •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 serious or uncontrollable systemic diseases, such as:
- •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 has received the following therapies: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs or drugs that target another stimulator or synergistically inhibit T cell receptors (e.g., CTLA-4, OX-40, CD137);
- •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
Experimental Group
Experimental
Participants receive 2-4 cycles of Tislelizumab combined with chemotherapy treatment during preoperative period, every 3 weeks for 4 cycles at most.
干预措施: Tislelizumab (Drug)
Experimental Group
Experimental
Participants receive 2-4 cycles of Tislelizumab combined with chemotherapy treatment during preoperative period, every 3 weeks for 4 cycles at most.
干预措施: Pemetrexed (Non-squamous NSCLC) or Nab-paclitaxel(Squamous NSCLC) (Drug)
Experimental Group
Experimental
Participants receive 2-4 cycles of Tislelizumab combined with chemotherapy treatment during preoperative period, every 3 weeks for 4 cycles at most.
干预措施: Carboplatin or Cisplatin (Drug)
Experimental Group
Experimental
Participants receive 2-4 cycles of Tislelizumab combined with chemotherapy treatment during preoperative period, every 3 weeks for 4 cycles at most.
干预措施: Surgery (Procedure)
结局指标
主要结局
R0 Resection Rate
时间窗: 1 month after surgery
R0 Resection Rate: The pathological results will showed that the incision margin was negative and no residual cancer cells were found under the microscope.
次要结局
- Major Pathological Response (MPR) Rate(1 month after surgery)
- Rate of grade 3 and higher grade treatment-related adverse events(From date of treatment allocation until surgery or within 30 days after last dose of preoperative treatment)
- Progression-Free Survival (PFS)(Up to 12 months)
- Objective Response Rate (ORR)(Pre-operation)
- Resectability Rate(Pre-operation)
研究者
jiaowenjie
Professor
The Affiliated Hospital of Qingdao University
研究点 (1)
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