Abstract：
Despite the positive results obtained by first-line chemoimmunotherapy in patients with metastatic non-small-cell lung cancer (NSCLC), only a few second-line options are available after disease progression. Combi-TED is a phase II international study that will assess the efficacy of Tedopi®, a cancer vaccine, combined with either docetaxel or nivolumab and compared with docetaxel monotherapy in patients with metastatic NSCLC after chemoimmunotherapy. The study, currently in the recruitment phase, will assess 1-year overall survival (primary end point), patient\'s progression-free survival and overall response rate, as well as the correlation of efficacy with several tumor or blood biomarkers. The results will hopefully provide more information on Tedopi combinational treatment compared with current standard of care in NSCLC patients who fail first-line chemoimmunotherapy. Clinical Trial Registration: NCT04884282 (ClinicalTrials.gov).
Patients with lung cancer that has spread to other parts of the body are usually treated with a combination of chemotherapy and drugs that stimulate the immune system to kill cancer cells, which is referred to as immunotherapy. If after receiving these drugs the cancer still gets worse, patients have only a few treatment options left and are usually treated with chemotherapy only. Researchers will study if a new medicine called Tedopi®, a vaccine that specifically attacks cancer cells, used together with chemotherapy or immunotherapy, will work better then chemotherapy alone for these patients. The study will monitor how long patients will live after treatment, for how long they will live without their disease getting worse and how many patients will improve after treatment. Moreover, researchers will study if patients present specific features, such as certain molecules in their tumor cells or blood cells, that may indicate that they respond better to certain treatments.
Patients with lung cancer that has spread to other parts of the body are usually treated with a combination of chemotherapy and drugs that stimulate the immune system to kill cancer cells, which is referred to as immunotherapy. If after receiving these drugs the cancer still gets worse, patients have only a few treatment options left and are usually treated with chemotherapy only. Researchers will study if a new medicine called Tedopi®, a vaccine that specifically attacks cancer cells, used together with chemotherapy or immunotherapy, will work better then chemotherapy alone for these patients. The study will monitor how long patients will live after treatment, for how long they will live without their disease getting worse and how many patients will improve after treatment. Moreover, researchers will study if patients present specific features, such as certain molecules in their tumor cells or blood cells, that may indicate that they respond better to certain treatments.
摘要：
尽管一线化学免疫疗法在转移性非小细胞肺癌（NSCLC）患者中获得了积极的结果，疾病进展后只有少数二线选择.Combi-TED是一项II期国际研究，将评估Tedopi®的疗效，癌症疫苗，联合多西他赛或纳武单抗治疗转移性NSCLC化疗后患者,并与多西他赛单药治疗进行比较.这项研究,目前处于招聘阶段，将评估1年总生存率（主要终点），患者的无进展生存期和总反应率，以及疗效与几种肿瘤或血液生物标志物的相关性。与一线化学免疫疗法失败的NSCLC患者的当前护理标准相比，该结果有望为Tedopi组合治疗提供更多信息。临床试验注册：NCT04884282（ClinicalTrials.gov）。
已经扩散到身体其他部位的肺癌患者通常采用化疗和刺激免疫系统杀死癌细胞的药物联合治疗，这被称为免疫疗法。如果在接受这些药物后癌症仍然恶化，患者只剩下很少的治疗选择，通常只接受化疗。研究人员将研究一种名为Tedopi®的新药，一种专门攻击癌细胞的疫苗，与化疗或免疫疗法一起使用，对这些患者来说，比单独化疗效果更好。这项研究将监测患者治疗后的寿命，他们会活多久，而他们的疾病不会恶化，治疗后有多少患者会好转。此外，研究人员将研究患者是否具有特定特征，例如肿瘤细胞或血细胞中的某些分子，这可能表明他们对某些治疗反应更好。
已经扩散到身体其他部位的肺癌患者通常采用化疗和刺激免疫系统杀死癌细胞的药物联合治疗，这被称为免疫疗法。如果在接受这些药物后癌症仍然恶化，患者只剩下很少的治疗选择，通常只接受化疗。研究人员将研究一种名为Tedopi®的新药，一种专门攻击癌细胞的疫苗，与化疗或免疫疗法一起使用，对这些患者来说，比单独化疗效果更好。这项研究将监测患者治疗后的寿命，他们会活多久，而他们的疾病不会恶化，治疗后有多少患者会好转。此外，研究人员将研究患者是否具有特定特征，例如肿瘤细胞或血细胞中的某些分子，这可能表明他们对某些治疗反应更好。
