NCT06249854

Efficacy and Safety of Combination Therapy With Bojungikki-tang and Pembrolizumab Monotherapy in Patients With Advanced Non-small Cell Lung Cancer

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Korea Institute of Oriental Medicine · Other Government
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a multicenter, open-label, randomized controlled clinical trial 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. A total of 70 patients aged 19 or older will be enrolled in the study and progression-free survival (PFS) will be assessed as the primary endpoint. In a pre-clinical study, the combination of immune checkpoint inhibitors(ICIs) and Bojungikki-tang extended the survival of mice compared to the administration of ICIs or BJIKT alone and reduced tumor volume and weight. In addition, it was confirmed that various immune-related factors in the tumor microenvironment were controlled to improve the immunosuppressed microenvironment and to strengthen the tumor immune response by increasing major immune cytokines in the blood. Furthermore, the combination of ICIs and BJIKT did not cause pharmacodynamic and pharmacokinetic drug interactions, and significant side effects of Bojungikki-tang were not observed in most clinical reports on long-term administration of Bojungikki-tang. Based on the results, the combination of BJIKT and ICIs is expected to improve survival and enhance the therapeutic efficacy of ICIs by modulating the systemic tumor-immune environment. In order to evaluate efficacy, variables including PFS, disease control rate (DCR), overall survival (OS), and quality of life will be used. The incidence rate of adverse events (AEs) and AEs with CTCAE grade 3 or higher will be assessed for safety. Most variables will be followed up during and after 45-week treatment, and the safety of interventions will be monitored consistently. Immune profiling and multi-omics analyses, including transcriptomic, proteomic, and metabolomic evaluations of PBMCs, will be conducted for exploratory purposes. In addition, pattern identification, a traditional diagnostic method in East Asian medicine, will be utilized as an exploratory variable. A validated questionnaire assessing Cold-Heat patterns, tongue diagnosis data, and pulse diagnosis data will be used to investigate their correlation with clinical and laboratory data.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Bojungikki-tang(BJIKT)	Bojungikgitang, which is a classical formulation widely used in South Korea, China, and Japan for a long time, has been reported to have following anticancer activities. 1. Protective effect of intestine and hematopoietic organs against radiation damage 2. Improving localized radiotherapy-induced immune deterioration 3. Improving cancer-related fatigue and QOL 4. Reducing radiation or chemotherapy induced side effects
DRUG	Pembrolizumab	It is a humanized antibody used in cancer immunotherapy for various types of cancer, including lung cancer. It targets the programmed cell death protein 1 (PD-1) receptor of lymphocytes. It was approved for medical use in the U.S. in 2014.

Timeline

• Start date: 2024-02-08
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2024-02-08
• Last updated: 2024-10-01

Locations

7 sites across 1 country: South Korea