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Clinical Trial
. 2024 Aug 21;14(1):19374.
doi: 10.1038/s41598-024-69587-x.

Immune killer cells treatment for previously treated stage IV NSCLC patients

Yen-Han Tseng  1   2 , Ching-Liang Ho  3 , Chih-Feng Chian  4 , Chi-Lu Chiang  1   2 , Heng-Sheng Chao  1   2 , Chen-Liang Tsai  4 , Wann-Cherng Perng  4 , Chin-Fu Hsiao  5 , Mei-Hsing Chuang  5 , Kai-Hsiung Ko  6 , Yun-Ching Cheng  7 , Shin-Jung Chen  7 , Chia-Jen Wang  7 , Yuh-Min Chen  8   9
Affiliations
Clinical Trial

Immune killer cells treatment for previously treated stage IV NSCLC patients

Yen-Han Tseng et al. Sci Rep. .

Abstract

The 5-year survival is poor for stage IV non-small cell lung cancer (NSCLC). Recently, cell immunotherapy has emerged as a new treatment strategy. This study aimed to evaluate the efficacy and safety of Immune killer cells (IKC) in patients with stage IV NSCLC after the failure of prior chemotherapy. This study enrolled 26 patients with stage IV NSCLC who failed at least two lines of chemotherapy with or without targeted therapy. The IKC was given alone weekly for 24 weeks. The primary endpoint was progression-free survival (PFS). Secondary outcomes included overall survival (OS), pain intensity, quality of life (QOL), and safety. The median PFS for the intent-to-treat (ITT) population (i.e., all enrolled patients) was 3.8 month. In the per-protocol (PP) population (i.e., patients receiving > 12 IKC infusions), the median PFS was 5.6 months. Moreover, the ITT population showed a 1-year survival rate of 60.0%, while that for the PP population was 85.7%. Only 7 out of 200 AEs (3.5%) were related to the IKC infusion, and they were all rated as grade 1 in severity. The IKC infusion was well tolerated. This novel immunotherapy prolonged the PFS and improved the survival compared with historical data. It might be a potential treatment strategy for stage IV NSCLC patient who failed prior chemotherapy.ClinicalTrials.gov identifier: NCT03499834.

Keywords: Cell immunotherapy; Immune killer cells; Non-small cell lung cancer; Overall survival; Safety.

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Conflict of interest statement

The authors declare no competing interests.

Figures

Figure 1
Figure 1
Consort diagram. Total 26 patients were enrolled. One patient died before IKC infusion. During IKC infusion, 11 patients withdrawal because of disease progression or by physician’s judgement. 14 patients received ≧ 12 times of IKC infusion and was defined as per protocol (PP) population. NSCLC non-small cell lung cancer, TKI tyrosin kinase inhibitor, IKC immune killer cells, ITT intention to treat population, PP per protocol population.
Figure 2
Figure 2
Progression free survival curve of ITT Population (upper) and PP population (lower).
Figure 3
Figure 3
Overall survival curve of ITT population (upper) and PP population (lower).
Figure 4
Figure 4
Waterfall plot of IKC infusion. The objective response rate were not associated with EGFR status, infused IKC amount, CTL percentage, or NKT percentage.
See this image and copyright information in PMC

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