OncoMatch/Clinical Trials/NCT06249854
Efficacy and Safety of Combination Therapy With Bojungikki-tang and Pembrolizumab Monotherapy in Patients With Advanced Non-small Cell Lung Cancer
Is NCT06249854 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Bojungikki-tang(BJIKT) and Pembrolizumab for non-small cell lung cancer.
Treatment: Bojungikki-tang(BJIKT) · Pembrolizumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: PD-L1 (CD274) tumor proportion score (TPS) ≥ 50% (TPS ≥ 50%)
Patients with PD-L1 tumor proportion score(TPS) ≥ 50%
Required: EGFR wild-type
no EGFR ... genomic tumor aberrations
Required: ALK wild-type
no ... ALK genomic tumor aberrations
Disease stage
Required: Stage IV
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: immune checkpoint inhibitor
Patients who treated with immune checkpoint inhibitor or anti-CTLA-4 within the last 6 weeks
Cannot have received: systemic immunosuppressive medication
Exception: low-dose corticosteroids (prednisone ≤ 10 mg/day or equivalent within 7 consecutive days) permitted at investigator's discretion
systemic immunosuppressive medications within the last 2 weeks
Cannot have received: herbal medicine
Patients who received herbal medicine within 4 weeks before the first administration of IP (Bojungikgitang) and been decided that such intake affect the trial or safety of the subject at the investigator's discretion
Cannot have received: investigational drug
Patients who received other investigational drugs within 30 days before the first administration of IP (Bojungikgitang)
Lab requirements
Blood counts
Hemoglobin ≥ 9.0 g/dL; Absolute neutrophil count (ANC) ≥ 1,500/㎕; Platelet count ≥100× 10^3/㎕
Kidney function
Serum creatinine ≤ 1.5x ULN or creatinine clearance ≥ 45 ml/min
Liver function
ALT and AST ≤ 2.5× ULN; with liver metastasis: ALT and AST ≤ 5× ULN; Total bilirubin ≤ 1.5× ULN; with liver metastasis or known Gilbert syndrome: Total bilirubin ≤ 3× ULN
Patients with adequate bone marrow reserve or organ function as follows: Hemoglobin ≥ 9.0 g/dL; ANC ≥ 1,500/㎕; Platelet count ≥100× 10^3/㎕; Serum creatinine ≤ 1.5x ULN or creatinine clearance ≥ 45 ml/min; ALT and AST ≤ 2.5× ULN; with liver metastasis: ALT and AST ≤ 5× ULN; Total bilirubin ≤ 1.5× ULN; with liver metastasis or known Gilbert syndrome: Total bilirubin ≤ 3× ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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