Combining Bojungikki-tang with Pembrolizumab for Advanced 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

This study is testing if combining a traditional herbal treatment with a cancer drug can help people with advanced lung cancer live longer and feel better.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 19 Years and up
• Sex: All
• Sponsor: Korea Institute of Oriental Medicine (other gov)
• Drugs / interventions: Pembrolizumab, prednisone
• Locations: 7 sites (Anyang-si, Gyeonggi-do and 6 other locations)
• Trial ID: NCT06249854 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of combining Bojungikki-tang (BJIKT) with pembrolizumab in patients with advanced non-small cell lung cancer (NSCLC) that expresses PD-L1 and lacks EGFR or ALK mutations. It is a multicenter, open-label, randomized controlled trial involving 70 participants aged 19 and older. The primary endpoint is progression-free survival (PFS), and the study aims to assess how this combination therapy can enhance immune response and improve patient outcomes based on previous pre-clinical findings. The trial will also monitor various immune-related factors and overall survival rates.

Who should consider this trial

Good fit: Ideal candidates are adults aged 19 or older with advanced NSCLC, PD-L1 positive tumors, and no EGFR or ALK genomic aberrations.

Not a fit: Patients with early-stage lung cancer or those with EGFR or ALK mutations may not benefit from this study.

Why it matters

Potential benefit: If successful, this combination therapy could significantly improve survival rates and treatment efficacy for patients with advanced non-small cell lung cancer.

How similar studies have performed: While the combination of immune checkpoint inhibitors and traditional therapies is being explored, this specific combination of BJIKT and pembrolizumab is novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

1. Patients who voluntarily decided to participate and provided written consent, after listening and understanding the detailed explanation about the clinical trial
2. Adult male or female aged 19 years or older
3. 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.
4. 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)
5. Life expectancy ≥ 3 months
6. ECOG (Eastern Cooperative Oncology Group) Performance Status score of 0\~2
7. Patients with at least 1 measurable lesion as defined in RECIST V1.1
8. 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

Exclusion Criteria:

1. Active brain metastases accompanied by clinically significant neurological symptoms or signs
2. Patients who diagnosed with another primary malignancy that affect non-small cell lung cancer in the last 5 years However, effectively treated non-melanoma skin cancer, carcinoma in situ of cervix, ductal carcinoma in situ of breast, thyroid cancer, or malignancies which were remained in remission during more than 3 years after being treated effectively and considered cured are permitted.
3. Patients who treated with immune checkpoint inhibitor or anti-CTLA-4 within the last 6 weeks or systemic immunosuppressive medications within the last 2 weeks However, low-dose corticosteroids (prednisone ≤ 10 mg/day or an equivalent dose of corticosteroid within 7 consecutive days) are permitted at the investigator's discretion.
4. Patients receiving thiazide or loop diuretics
5. Hypokalemia (less than 3.0 mEq/L)
6. Active interstitial lung disease requiring oral or intravenous steroid treatment
7. Patients with autoimmune disease requiring systemic treatment at the time of enrollment
8. Uncontrolled diabetes mellitus at the time of enrollment (Uncontrolled with insulin and oral medications, HbA1c ≥ 8.0% or fasting blood sugar ≥ 200 mg/dL)
9. Patients with uncontrolled hypertension at the time of enrollment (systolic pressure \> 150 mmHg or diastolic pressure \>100 mmHg) despite use of antihypertensive agent
10. Patients with uncontrolled heart disease (severe heart failure, unstable angina, uncontrolled arrhythmia, or history of life-threatening arrhythmia, etc.)
11. Patients with hereditary problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption, etc.
12. Patient with known active or uncontrolled HIV, tuberculosis, hepatitis B, or hepatitis C infection
13. Pregnant or lactating women
14. Patients who do not agree to use effective contraception during treatment period and for at least 5 months after the end of IP administration
15. 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
16. Patients who received other investigational drugs within 30 days before the first administration of IP (Bojungikgitang)
17. Severe hypersensitivity to IP and its components (rash, redness, hives, eczema, dermatitis, itching, etc.)
18. Patients who are not eligible for the trial at the discretion of the investigator including severe infectious diseases or organ failure, etc.

Where this trial is running

Anyang-si, Gyeonggi-do and 6 other locations

• Hallym University Medical Center — Anyang-si, Gyeonggi-do, South Korea (RECRUITING)
• Pusan National University Yangsan Hospital — Yangsan, Gyeongsangnam-do, South Korea (RECRUITING)
• Kyung Hee University Hospital — Seoul, South Korea (RECRUITING)
• Hanyang University Seoul Hospital — Seoul, South Korea (RECRUITING)
• Samsung medical center — Seoul, South Korea (RECRUITING)
• Korea University Guro Hospital — Seoul, South Korea (RECRUITING)
• The catholic university of Korea Seoul Saint. Mary's hospital — Seoul, South Korea (RECRUITING)

Study contacts

• Principal investigator: Sung Yong Lee, Ph.D — Koera University Guro Hospital
• Study coordinator: Mi-Kyung Jeong, Ph.D

Conditions: Non-small Cell Lung Cancer, Bojungikki-tang, Buzhong Yiqi decoction, Hochu-ekki-to