Objective To evaluate the clinical efficacy of Fried Licorice Decoction Plus-minus in combination with PD-1 therapy for patients with advanced non-small cell lung cancer (NSCLC) with Qi-Yin deficiency.

Methods From December 2020 to December 2022, 72 patients diagnosed with advanced NSCLC with Qi-Yin deficiency were enrolled in this study. The patients were recruited from Jilin Provincial Cancer Hospital and the Affiliated Hospital of Changchun University of Chinese Medicine. The patients were randomly assigned into two groups, with 36 patients in each group. The control group received PD-1 treatment alone, and the treatment group received PD-1 combined with Fried Licorice Decoction Plus-minus. The measures of primary outcomes included immune function (CD3⁺, CD3⁺/CD4⁺, and CD3⁺/CD8⁺) and quality of life score (Kamofsky, KPS). The measures of secondary outcomes included the objective response rate (ORR); traditional Chinese medicine (TCM) symptom score; serum tumor marker carcinoembryonic antigen (CEA); neuron-specific enolase (NSE); cytokeratin fragment (CYFRA211); and incidence of immune-related adverse events such as gastrointestinal toxicity, pulmonary toxicity, hepatotoxicity, and thyroid toxicity.

Results Regarding immune function regulation, a significant improvement was observed in CD3⁺, CD3⁺/CD4⁺, and CD3⁺/CD8⁺. Furthermore, at T3 and T4 time points, an improvement was observed in patient quality of life indicators such as the tumor markers CEA and CY211. In addition, symptoms related to TCM syndrome, including coughing, fatigue, palpitations, and diarrhea were significantly reduced compared to the baseline levels. Moreover, the treatment group exhibited superior outcomes compared to those of the control group in terms of reducing immune-associated pneumonia and diarrhea (P<0.05). The ORR for both groups was similar; 36% for those receiving combination therapy vs. 25% for those receiving PD-1 monotherapy. Therefore, no significant differences between these two groups were observed (P>0.05).

Conclusions The combination of Fried Licorice Decoction Plus-minus and PD-1 in the treatment of patients with advanced NSCLC showed a significant enhancement in immune function, improvement in clinical efficacy, reduction in immune-related adverse reactions, and had an excellent safety profile.