Trial Title:
The Impact of Probiotic on Survival and Treatment Response in Metastatic Non-small Cell Lung Cancer Patients
NCT ID:
NCT06428422
Condition:
Metastatic Non-small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Conditions: Keywords:
immunotherapy
lung cancer
probiotics
Bifidobacterium animalis
microbiota
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Outcomes Assessor)
Intervention:
Intervention type:
Dietary Supplement
Intervention name:
Bifidobacterium animalis subsp. lactis Bl-04
Description:
4 x 10^9 cfu/g/day Bifidobacterium animalis subsp. lactis Bl-04 for 12 weeks
Arm group label:
Intervention group
Intervention type:
Other
Intervention name:
Plasebo
Description:
1 g/day maltodextrin for 12 weeks
Arm group label:
Plasebo group
Summary:
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.
Detailed description:
Despite modern treatments, lung cancer remains a leading cause of high mortality
worldwide. Over the past decade, significant improvements in patient survival have been
achieved with immune checkpoint inhibitors, which enhance the T cell-mediated immune
response to eradicate cancer cells. However, therapeutic resistance, drug side effects,
and heterogeneous treatment responses limit their effectiveness. Recent studies have
established a clear relationship between gut microbiota and cancer immunotherapy. The
intestinal microbiota has been shown to stimulate the anti-tumor immune response by
modulating immune system cells. Evidence from preclinical and clinical studies indicates
that gut microbiota plays a crucial role in the efficacy of immunotherapy and the
modulation of drug toxicity. Identifying the microbiota as a potential biomarker could
facilitate personalized treatment protocols. Genetic, epigenetic, and microbiota
modulation factors are essential for optimizing cancer immunotherapy outcomes.
Consequently, research is increasingly focusing on personalized treatment protocols for
microbiota modulation, including diet regulation, fecal microbiota transfer, prebiotics,
and probiotics. There has been a significant rise in studies demonstrating the clinical
benefits of microbial therapy products as complementary treatments.
The functional role of microbiota in modulating the systemic immune response has prompted
investigations into its impact on cancer immunotherapy, particularly with agents
targeting immunological checkpoints like PD-1. Recent studies have identified both
positive and negative regulatory bacteria that influence immunotherapy effectiveness.
However, sociocultural and dietary lifestyle differences affect gut microbiota
composition, leading to variations between populations. Therefore, studies are needed to
identify the unique microbiome composition of each population to develop microbiota
biological indicators for cancer immunotherapy. No research has been conducted in this
area in Türkiye. This study aims to identify bacterial species that may serve as
biomarkers for the microbiota specific to Turkish cancer patients receiving immunotherapy
and use them for prognostic purposes.
Understanding the significant role of probiotics in modulating intestinal microbiota has
increased the demand for these food supplements. Studies show that anti-tumor efficacy is
specific to the bacterial strain. For instance, Bifidobacteriums have been reported to
enhance the effectiveness of PD-1 blockers in experimental rat models. In another study,
B. lactis BL-04 reduced immunotherapy-induced colitis in animals.
This study will investigate the effect of a probiotic supplement containing
Bifidobacterium animalis lactis BL-04 on clinical objective response, clinical benefit
rates, and intestinal microbiota in patients with metastatic non-small cell lung cancer
(mNSCLC) receiving nivolumab. The results may facilitate the development of specific
probiotic supplements as a complementary therapy for mNSCLC treatment.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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/mm³, Neutrophil count > 1,500/mm³,Platelet count >
100,000/mm³
Exclusion Criteria:
- 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.
Gender:
All
Minimum age:
19 Years
Maximum age:
90 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Necmettin Erbakan University
Address:
City:
Konya
Zip:
42090
Country:
Turkey
Status:
Recruiting
Contact:
Last name:
Mehmet Artaç, MD
Phone:
+903322236000
Phone ext:
6434
Email:
martac@erbakan.edu.tr
Investigator:
Last name:
Mehmet Artaç, MD
Email:
Principal Investigator
Investigator:
Last name:
Hasibe Artaç, MD
Email:
Sub-Investigator
Investigator:
Last name:
Murat Araz, MD
Email:
Sub-Investigator
Investigator:
Last name:
Melek Karakurt Eryılmaz, MD
Email:
Sub-Investigator
Investigator:
Last name:
Selin Uğraklı, MD
Email:
Sub-Investigator
Investigator:
Last name:
Yunus Emre Tunçil, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Mehmet Zahid Koçak, MD
Email:
Sub-Investigator
Investigator:
Last name:
Muzaffer Uğraklı, MD
Email:
Sub-Investigator
Investigator:
Last name:
Ayça Ceylan, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Şenay Burçin Alkan, PhD
Email:
Sub-Investigator
Start date:
August 12, 2024
Completion date:
December 20, 2026
Lead sponsor:
Agency:
Necmettin Erbakan University
Agency class:
Other
Collaborator:
Agency:
Health Institutes of Türkiye (TUSEB)
Agency class:
Other
Source:
Necmettin Erbakan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06428422
