None listed
Conditions
Interventions
Drug : 1. Bojungi granule(Bojungikki-tang)
- 4g per bag (include 2.5g of Bojungikii-tang extract)
- 1 bag per meal (4g at a time), twice a day (take orally before or between meals in the morning and e
Sponsors
Koera University Guro Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adult male and female aged 19 years old and above 2) (According to TNM 8th edition) patient diagnosed with stage IIIB, IIIC, or IV non-small cell lung cancer 3) Patient planned for single treatment of Atezolizumab, an immune checkpoint inhibitor, as second and subsequent line therapy under permission - Patient with advanced or metastatic non-small cell lung cancer whose disease have progressed during or after approved platinum-based chemotherapy - Patients with EGFR or ALK mutant who are confirmed disease progression after approved treatment for these mutations and have failed prior platinum-based chemotherapy 4) Patient who is expected to survive more than 3 months 5) Patient whose ECOG PS score is 2 and below 6) Patient who has measurable or evaluable lesion defined in RECIST v1.1 7) Patient with good hematological function - Hemoglobin = 9.0 g/dL - Absolute Neutrophil Count(ANC) =1,500/? - Platlet = 100× 103/? 8) Patient with good renal function - Creatinine = 1.5× ULN - Creatinine clearance = 45 mL/min 9) Patient with good liver function - ALT, AST = 2.5× ULN. ALT, AST = 5× ULN, for subject with liver metastasis - Total bilirubin =1.5× ULN. Total bilirubin =3x ULN, for subject with liver metastasis or Gilbert Syndrome(unconjugated hyperbilirubinemia) in medical history, 10) A person who voluntarily decided to participate and consented in writing, after listening and understanding the detailed explanation about this clinical trial
Exclusion criteria
Exclusion criteria: 1) Patient who had been diagnosed within the last 5 years with new primary cancer or others that effects non-small cell lung cancer. 2) In case of receiving immune suppressive drug within the last 2 weeks, or immune-checkpoint inhibitor, anti-CTLA-4 treatment within the last 6 weeks 3) In case of receiving antibiotics within the last 2 weeks 4) In case of taking Thiazide or Loop diuretic 5) In case of hypokalemia 6) In case of having interstitial lung disease in medical history 7) Patient with active autoimmune disease who required systemic therapy within the last 2 years 8) Patient with uncontrolled diabetes (uncontrolled with insulin or oral medication, fasting blood sugar) 9) Patient with uncontrolled hypertension (In case of systolic above 150mg or diastolic over 100mg, while taking blood pressure medicine) 10) Patient with heart defect (heart failure, angina, arrhythmia etc.) 11) Patient with genetic issues such as galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption and so on 12) Patient infected with active or untreated HIV, tuberculosis, Hepatitis B or Hepatitis C 13) Patient with significant hematologic disease(i.e., aneurysm requiring surgical operation or recent peripheral artery thrombosis) within 6 months before randomization 14) Patient with significant hematologic disease(i.e., aneurysm requiring surgical operation or recent peripheral artery thrombosis) within 6 months before randomization 15) Patient who has abdominal cavity, esophageal atresia or gastrointestinal duct perforation in medical history within 6 months before randomization 16) Patient who is yet unsolved with toxicity over CTCAE v5.0 level1 resulting from previous therapy when the trial therapy starts 17) A person who is seriously hypersensitive to ingredients in investigational drug.(rash, flare, hives, eczema, dermatitis, itchiness etc.) 18) Pregnant or lactating patient 19) In case of fertile women, patient who disagrees with use of effective contraception method for at least 5 months after the final administration of Atezolizumab, an immune-checkpoint inhibitor, during this clinical trial 20) Patient who took oriental medicine or functional food(ginseng etc.) within 4 weeks before the initial treatment of investigational drug and been decided by the investigator that such intake might effect the trial or subject’s safety 21) Patients who have participated in clinical trial within 4 weeks before the first administration of an investigational drug 22) Patient who’ve been decided unsuitable for this clinical trial by investigator including serious infectious disease or organ failure and others
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of AEs (irAEs + non-irAEs, irAEs, non-irAEs) and incidence of AEs over CTCAE grade 3 ;Symptom improvement in fatigue and skeletal muscle loss ;Objective response rate (ORR) with Atezolizumab | — |
Secondary
| Measure | Time frame |
|---|---|
| Early termination rate and withdrawal period of Atezolizumab, early termination rate due to reaching above CTCAE grade 3;Among ADR of Atezolizumab single therapy in clinical trial, incidence of 17 events, among AEs above CTCAE Grade 3 and incidence rate over 1% & incidence of 3 events, among irAE with incidence rate over 1% ;Among ADR of Atezolizumab combined therapy in clinical trial, incidence of 9 events, among AEs above CTCAE Grade 3 and incidence rate over 1%;Relationship between immune parameter values and outcomes of Atezolizumab/Bojungilkki-tang treatment or patient's cold-heat pattern type | — |
Countries
Korea, Republic of
Contacts
Public ContactMi-kyung Jeong
Korea Institute of Oriental Medicine
Outcome results
None listed