KCT0009012尚未招募Unknown
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
Koera University Guro Hospital0 个研究点目标入组 70 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •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×
排除标准
- •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.
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