RecruitingPhase 2NCT06249854

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

Sponsor

Korea Institute of Oriental Medicine

Enrollment

70 participants

Start Date

Feb 8, 2024

Study Type

INTERVENTIONAL

Conditions

Non-small Cell Lung Cancer

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.

Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether combining an herbal Korean medicine called Bojungikki-tang with the immunotherapy drug pembrolizumab improves outcomes compared to pembrolizumab alone in people with advanced (stage IV) non-small cell lung cancer (NSCLC). Bojungikki-tang is a traditional formula thought to support immune function and overall vitality. **You may be eligible if...** - You are 19 or older - You have confirmed advanced NSCLC (stage IV) - Your cancer has high PD-L1 expression (TPS ≥50%) and no EGFR or ALK mutations - You have not yet received any treatment for advanced lung cancer - You are in adequate physical condition (ECOG 0–2) **You may NOT be eligible if...** - Your cancer has EGFR or ALK mutations (different targeted treatments apply) - Your PD-L1 expression is below 50% - You have received prior systemic treatment for advanced NSCLC - You have significant organ problems or active autoimmune disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBojungikki-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

DRUGPembrolizumab

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.