Actively Recruiting
The Impact of Probiotic on Survival and Treatment Response in Metastatic Non-small Cell Lung Cancer Patients
Led by Necmettin Erbakan University · Updated on 2024-08-16
100
Participants Needed
1
Research Sites
122 weeks
Total Duration
On this page
Sponsors
N
Necmettin Erbakan University
Lead Sponsor
H
Health Institutes of Turkey
Collaborating Sponsor
AI-Summary
What this Trial Is About
The aim of this study is to evaluate the effect of a probiotic supplement containing Bifidobacterium animalis lactis BL-04 on the clinical effectiveness of immunotherapy in patients diagnosed with metastatic non-small cell lung cancer who are receiving immunotherapy.
CONDITIONS
Official Title
The Impact of Probiotic on Survival and Treatment Response in Metastatic Non-small Cell Lung Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Volunteering to participate in the study.
- Histologically confirmed diagnosis of Non-Small Cell Lung Cancer (NSCLC).
- Patients must be in an advanced stage (incurable with surgery or radiotherapy) or have metastatic disease (Stage IV).
- Male or female patients aged >18 years.
- Eastern Cooperative Oncology Group (ECOG) Performance Status less than 2.
- Laboratory findings must confirm adequate bone marrow function, indicated by:
White Blood Cell (WBC) count > 2,000/mm9, Neutrophil count > 1,500/mm9, Platelet count > 100,000/mm9
You will not qualify if you...
- Previously received treatment with any of the following antibody blockers: anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4.
- Currently taking probiotic supplements or consuming probiotic bacteria-supported yogurt and similar food supplements.
- Antibiotic utilization within the past month.
- Active interstitial lung disease or a history of interstitial lung disease requiring systemic steroid treatment.
- A condition requiring systemic corticosteroids (greater than 10 mg of prednisone daily or equivalent) or who have received immunosuppressive treatment within 14 days prior to the first dose of the study.
- Presence of uncontrolled adrenal insufficiency.
- Pregnancy or breastfeeding.
- Severe congestive heart failure (Class III or higher according to the New York Heart Association Functional Classification) or a history of myocarditis.
- Uncontrolled cardiac arrhythmia that developed within six months prior to the start of the study.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Necmettin Erbakan University
Konya, Turkey (Türkiye), 42090
Actively Recruiting
Research Team
M
Mehmet Artaç, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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