A Multicenter, Open Label, Randomized Controlled Clinical Trial to Evaluate the Efficacy and Safety of Combination Therapy With Bojungikki-tang and Pembrolizumab Monotherapy in Patients With Advanced Non-small Cell Lung Cancer
This is a multicenter, open-label, randomized controlled clinical trial designed to evaluate the efficacy and safety of combination therapy with Bojungikki-tang(BJIKT) and pembrolizumab monotherapy in patients with advanced non-small cell lung cancer whose tumors express PD-L1 positive with no EGFR or ALK genomic tumor aberrations. Based on prior pre-clinical studies, the combination of Bojungikki-tang and immune checkpoint inhibitors (ICIs) can be expected to improve survival and enhance the therapeutic efficacy of ICIs by modulating the systemic tumor-immune environment. Therefore, this clinical trial aims to assess the efficacy and safety of the combined therapy with BJIKT and pembrolizumab and establish clinical evidence for an integrative cancer treatment strategy by examining the survival rate and immune status following combined ICI and BJIKT treatment.
• Patients who voluntarily decided to participate and provided written consent, after listening and understanding the detailed explanation about the clinical trial
• Adult male or female aged 19 years or older
• Patients with histologically or cytologically confirmed advanced (stage IV) non-small cell lung cancer \[according to TNM 8th edition\] In case of recurrence, only extra-thoracic metastasis is allowed.
• Patients planned for immune checkpoint inhibitor (Pembrolizumab) monotherapy as first-line treatment (Patients with PD-L1 tumor proportion score(TPS) ≥ 50% and no EGFR or ALK genomic tumor aberrations)
• Life expectancy ≥ 3 months
• ECOG (Eastern Cooperative Oncology Group) Performance Status score of 0\
∙ 2
• Patients with at least 1 measurable lesion as defined in RECIST V1.1
• Patients with adequate bone marrow reserve or organ function as follows:
‣ Hemoglobin ≥ 9.0 g/dL
⁃ Absolute neutrophil count (ANC) ≥ 1,500/㎕
⁃ Platelet count ≥100× 10\^3/㎕
⁃ Serum creatinine ≤ 1.5x ULN or creatinine clearance ≥ 45 ml/min (measured using standard methods at the study site)
⁃ ALT and AST ≤ 2.5× ULN Patients with liver metastasis: ALT and AST ≤ 5× ULN
⁃ Total bilirubin ≤ 1.5× ULN Patients with liver metastasis or known Gilbert syndrome(unconjugated hyperbilirubinemia): Total bilirubin ≤ 3× ULN