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

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.)