Actively Recruiting
Efficacy and Safety of Combination Therapy With Bojungikki-tang and Pembrolizumab Monotherapy in Patients With Advanced Non-small Cell Lung Cancer
Led by Korea Institute of Oriental Medicine · Updated on 2024-10-01
70
Participants Needed
7
Research Sites
98 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multicenter, open-label, randomized controlled clinical trial designed to evaluate the efficacy and safety of combination therapy with Bojungikki-tang(BJIKT) and pembrolizumab monotherapy in patients with advanced non-small cell lung cancer whose tumors express PD-L1 positive with no EGFR or ALK genomic tumor aberrations. Based on prior pre-clinical studies, the combination of Bojungikki-tang and immune checkpoint inhibitors (ICIs) can be expected to improve survival and enhance the therapeutic efficacy of ICIs by modulating the systemic tumor-immune environment. Therefore, this clinical trial aims to assess the efficacy and safety of the combined therapy with BJIKT and pembrolizumab and establish clinical evidence for an integrative cancer treatment strategy by examining the survival rate and immune status following combined ICI and BJIKT treatment.
CONDITIONS
Official Title
Efficacy and Safety of Combination Therapy With Bojungikki-tang and Pembrolizumab Monotherapy in Patients With Advanced Non-small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who voluntarily agree to participate and provide written consent
- Adults aged 19 years or older
- Histologically or cytologically confirmed advanced (stage IV) non-small cell lung cancer; for recurrence, only extra-thoracic metastasis allowed
- Planned for pembrolizumab monotherapy as first-line treatment with PD-L1 tumor proportion score ≥ 50% and no EGFR or ALK genomic tumor aberrations
- Life expectancy of at least 3 months
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 to 2
- At least one measurable lesion as defined by RECIST V1.1
- Adequate bone marrow and organ function including hemoglobin ≥ 9.0 g/dL, absolute neutrophil count ≥ 1,500/μL, platelet count ≥ 100,000/μL, creatinine clearance ≥ 45 ml/min or serum creatinine ≤ 1.5x upper limit of normal (ULN), liver enzymes (ALT and AST) ≤ 2.5x ULN or ≤ 5x ULN if liver metastasis present, total bilirubin ≤ 1.5x ULN or ≤ 3x ULN if liver metastasis or Gilbert syndrome present
You will not qualify if you...
- Active brain metastases with significant neurological symptoms or signs
- Diagnosis of another primary malignancy affecting lung cancer in the last 5 years, except certain effectively treated cancers in remission for over 3 years
- Treatment with immune checkpoint inhibitors or anti-CTLA-4 within last 6 weeks or systemic immunosuppressive medications within last 2 weeks (low-dose corticosteroids allowed)
- Use of thiazide or loop diuretics
- Hypokalemia (less than 3.0 mEq/L)
- Active interstitial lung disease requiring steroid treatment
- Autoimmune disease needing systemic treatment at enrollment
- Uncontrolled diabetes mellitus (HbA1c ≥ 8.0% or fasting blood sugar ≥ 200 mg/dL)
- Uncontrolled hypertension (systolic > 150 mmHg or diastolic > 100 mmHg) despite medication
- Uncontrolled heart disease including severe heart failure or life-threatening arrhythmias
- Hereditary disorders such as galactose intolerance or glucose-galactose malabsorption
- Known active or uncontrolled HIV, tuberculosis, hepatitis B, or hepatitis C infections
- Pregnant or breastfeeding women
- Not agreeing to use effective contraception during treatment and for 5 months after
- Use of herbal medicine within 4 weeks before starting Bojungikki-tang if deemed unsafe
- Participation in other investigational drug studies within 30 days before starting Bojungikki-tang
- Severe allergic reactions to study drugs or components
- Any other condition making the participant unsuitable as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Hallym University Medical Center
Anyang-si, Gyeonggi-do, South Korea, 14068
Actively Recruiting
2
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, South Korea, 50612
Actively Recruiting
3
Kyung Hee University Hospital
Seoul, South Korea, 02447
Actively Recruiting
4
Hanyang University Seoul Hospital
Seoul, South Korea, 04763
Actively Recruiting
5
Samsung medical center
Seoul, South Korea, 06351
Actively Recruiting
6
Korea University Guro Hospital
Seoul, South Korea, 08308
Actively Recruiting
7
The catholic university of Korea Seoul Saint. Mary's hospital
Seoul, South Korea
Actively Recruiting
Research Team
M
Mi-Kyung Jeong, Ph.D
CONTACT
E
Eunbyul Cho
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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