Can an ancient herbal tonic boost modern immunotherapy against lung cancer?
NCT ID NCT06249854
First seen Aug 05, 2026 · Last updated Aug 06, 2026 · Updated 1 time
Summary
This trial is testing whether adding the traditional herbal remedy Bojungikki-tang to the immunotherapy drug pembrolizumab can help people with advanced non-small cell lung cancer. The study includes adults with stage IV disease whose tumors are PD-L1 positive and who have no EGFR or ALK mutations. Researchers will compare the combination against pembrolizumab alone, looking at progression-free survival, overall survival, and quality of life.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Bojungikki-tang (an herbal remedy) combined with pembrolizumab (an immunotherapy drug)
- What this could lead to
- If it works, this combination could improve survival and quality of life for people with advanced lung cancer, offering a new integrative treatment strategy.
- What could go wrong
- This is a small, early-stage trial, so results may not be conclusive. The herbal remedy could also interact with immunotherapy or cause side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
26 people
The number who actually took part.
- Started
-
Feb 2024
- Finished
-
Dec 2025
- Lead sponsor
-
A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
19 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Non-small cell lung cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Hallym University Medical Center
Anyang-si, Gyeonggi-do, 14068, South Korea
-
Hanyang University Seoul Hospital
Seoul, 04763, South Korea
-
Korea University Guro Hospital
Seoul, 08308, South Korea
-
Kyung Hee University Hospital
Seoul, 02447, South Korea
-
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, 50612, South Korea
-
Samsung medical center
Seoul, 06351, South Korea
-
The catholic university of Korea Seoul Saint. Mary's hospital
Seoul, South Korea
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Two-Drug combo targets stubborn KRAS lung cancer
- Smaller chest drain may speed recovery after lung cancer surgery
- Gut bacteria may hold clues to why some cancer treatments work better
- Breath-Tracking sensor aims to sharpen lung cancer scans
- Can PET scan signals predict who beats lung cancer with immunotherapy?
- Two-Drug combo takes aim at Hard-to-Treat lung cancer