A Prospective, Single-arm, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Tafolecimab and Sintilimab Combined With Chemotherapy in Patients With Advanced or Metastatic Driver Gene-negative Non-small Cell Lung Cancer After Failure of First-line Immunotherapy.

Jinghui Wang1 个研究点分布在 1 个国家目标入组 30 人开始时间: 2024年5月17日最近更新: 2024年5月20日

适应症

干预措施

试验速览

阶段: 2 期
状态: 招募中
发起方
入组人数: 30
试验地点: 1
主要终点: PFS

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The second-line treatment for patients who have progressed after first-line immune checkpoint inhibitor therapy, is chemotherapy based on docetaxel and other drugs. The treatment effect is limited. The median survival time of them are 6 months. So there is a huge unmet medical need.

This study is a Prospective, Single-arm, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Tafolecimab and Sintilimab Combined With Chemotherapy in Patients With Advanced or Metastatic Driver Gene-negative Non-small Cell Lung Cancer After Failure of First-line Immunotherapy. 30 patients will be enrolled.

The main endpoint is PFS，and the secondary endpoint are OS,DCR,DOR,ORR, and so on.

详细描述

This is a Prospective, Single-arm, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Tafolecimab and Sintilimab Combined With Chemotherapy in Patients With Advanced or Metastatic Driver Gene-negative Non-small Cell Lung Cancer After Failure of First-line Immunotherapy.

30 patients will be enrolled. These patients will be treated with chemotherapy combined with sintilimab and Tafolecimab.

The main endpoint is PFS，and the secondary endpoint are OS,DCR,DOR,ORR, and so on.

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

未提供

排除标准

•The pathology is small cell lung cancer (SCLC), including lung cancer that is a mixture of SCLC and NSCLC;
•Have received the following treatments:
•Received systemic anti-tumor treatment within 3 weeks before treatment, such as chemotherapy, targeted therapy, immunotherapy (including Chinese herbal treatment with anti-tumor indications), etc.; 2) Have received any investigational drug treatment within 4 weeks before treatment; 3) Received large doses of immunosuppressive drugs (systemic glucocorticoids exceeding 10 mg/day of prednisone or its equivalent) within 4 weeks before treatment; 4) Have received live attenuated vaccines within 4 weeks before treatment (or plan to receive live attenuated vaccines during the study); 5) Have undergone major surgery (such as open cavity, thoracotomy or Kaifu surgery) within 4 weeks before treatment, or have unhealed surgical wounds, ulcers or fractures.
•There is clinically uncontrollable pleural effusion/abdominal effusion (subjects who do not need to drain the effusion or who stop drainage for 3 days without significant increase in effusion can be enrolled);
•Subjects who have received chest radiation therapy greater than 30Gy within 6 months before treatment or palliative radiation therapy with a dose of 30Gy or less within 7 days before treatment (palliative treatment for bone lesions or intracranial lesions is allowed) Radiation Therapy);
•Active autoimmune disease that requires systemic treatment (such as the use of disease-modifying drugs, glucocorticoids, or immunosuppressants) has occurred within 2 years before the first dose. Replacement therapies (such as thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency, etc.) are not considered systemic treatments;
•Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation;
•Those who are known to be allergic to the active ingredients or excipients of tolesimab, the study drug;
•Have not fully recovered from toxicity and/or complications caused by any intervention before initiating treatment (i.e., ≤Grade 1 or reaching baseline, excluding fatigue or alopecia);
•Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive);
•Untreated active hepatitis B (defined as HBsAg positivity and a detected HBV-DNA copy number greater than the upper limit of normal value in the laboratory of the research center);
•Note: Hepatitis B subjects who meet the following criteria can also be enrolled:
•If the HBV viral load is <1000 copies/ml (200 IU/ml) before the first dose, the subject should receive anti-HBV treatment during the entire study chemotherapy drug treatment period to avoid viral reactivation.
•Subjects with anti-HBc (+), HBsAg (-), anti-HBs (-) and HBV viral load (-) do not need to receive prophylactic anti-HBV treatment, but need to be closely monitored for viral reactivation
•Subjects with active HCV infection (HCV antibody positive and HCV-RNA level higher than the lower limit of detection);
•Get live vaccine within 30 days before the first dose (cycle 1, day 1); Note: Injectable inactivated virus vaccine against seasonal influenza is allowed within 30 days before the first dose; however, intranasal live attenuated influenza vaccine is not allowed.
•Pregnant or lactating women;