背景： 评价同种异体CD8自然杀伤T（CD8 NKT）免疫疗法联合吉非替尼治疗晚期或转移性EGFR突变非小细胞肺癌（NSCLC）的疗效和安全性。方法：本研究是前瞻性的。具有外显子 19 (Ex19del) 或外显子 21 L858R 点突变且对吉非替尼治疗有反应的 NSCLC 患者被纳入试验，并随机分配至吉非替尼组和吉非替尼/NKT 组。在吉非替尼/NKT 组中，同种异体 CD8 NKT 细胞在体外培养并通过静脉适应性转移到患者体内。主要终点是无进展生存期（PFS）。次要终点分析包括疾病进展时间（TTP）、总生存期（OS）、血液中癌胚抗原（CEA）和丙氨酸转氨酶（ALT）的血清肿瘤标志物水平、缓解率和安全性。 2017年7月至2021年6月，19名患者被随机分配至吉非替尼组（n = 8）和吉非替尼/NKT组（n = 11）。结果：吉非替尼/NKT 组的估计中位生存 PFS 显着长于吉非替尼组（12 个月 vs 7 个月）。中位 TTP 也观察到类似的结果。此外，吉非替尼/NKT 组比吉非替尼组具有更好的 CEA 控制。吉非替尼/NKT 组和吉非替尼组分别有 64% 和 39% 的患者发生临床 3 级不良反应。吉非替尼/NKT组最常见的3级不良事件包括8例（73%）肝功能异常和1例（9%）腹泻，均在药物干预后得到缓解。结论：同种异体CD8 NKT细胞联合吉非替尼治疗EGFR突变晚期NSCLC的PFS比单用吉非替尼更长。无明显严重不良反应发生，患者依从性和生存状况良好。

Background: To evaluate the efficacy and safety of allogenic CD8 + natural killer T (CD8+ NKT) immunotherapy combined with gefitinib in the treatment of advanced or metastatic EGFR mutant non-small cell lung cancer (NSCLC). Methods: This study is prospective. The NSCLC patients with exon 19 (Ex19del) or exon 21 L858R point mutations, and response to gefitinib treatment were enrolled into the trial to be randomly assigned into the gefitinib arm and the gefitinib/NKT arm. Allogenic CD8+ NKT cells were cultured in vitro and adaptive transferred into the patients via vein in the gefitinib/NKT arm. The primary endpoint was progression-free survival (PFS). Secondary endpoint analysis included time to disease progression (TTP), overall survival (OS), levels of serum tumour markers for carcinoembryonic antigen (CEA) and alanine aminotransferase (ALT) in the blood, the response rate and safety. From July 2017 to June 2021, 19 patients were randomly assigned to the gefitinib arm (n = 8) and the gefitinib/NKT arm (n = 11). Results: The estimated median survival PFS in the gefitinib/NKT arm was significantly longer than that of the gefitinib arm (12 months vs 7 months). Similar results were also observed for the median TTP. Moreover, the gefitinib/NKT arm had better CEA control than the gefitinib arm. Clinical grade 3 adverse reactions occurred in 64% and 39% of patients in the gefitinib/NKT arm and the gefitinib arm, respectively. The most common grade 3 adverse events in the gefitinib/NKT arm included abnormal liver function in 8 cases (73%) and diarrhoea in 1 case (9%), both of which resolved after drug intervention. Conclusion: The PFS of EGFR-mutated advanced NSCLC treated with allogenic CD8+ NKT cells combined with gefitinib was longer than that of gefitinib alone. No obvious serious adverse reactions occurred, and the patients compliance and survival status were good.