Metastatic Non-small Cell Lung CancerNCT06428422
The Impact of Probiotic on Survival and Treatment Response in Metastatic Non-small Cell Lung Cancer Patients
A study testing Bifidobacterium animalis subsp. lactis Bl-04 and Plasebo in people with Metastatic Non-small Cell Lung Cancer, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 90 years
- Conditions the study is for
- Metastatic Non-small Cell Lung Cancer
- What is being tested?
- Bifidobacterium animalis subsp. lactis Bl-04 and Plasebo
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Aug 2024to 20 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Necmettin Erbakan University
Konya, 42090
Mehmet Artaç, MD, +903322236000 ext. 6434, martac@erbakan.edu.tr
Mehmet Artaç, MD
About this study
Official title: The Impact of Bifidobacterium Lactis Supplementation on Survival and Treatment Response in Metastatic Non-small Cell Lung Cancer Patients Receiving Immunotherapy (Nivolumab)
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.
Read the 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.
- Conditions
- Metastatic Non-small Cell Lung Cancer
- Being tested
- Bifidobacterium animalis subsp. lactis Bl-04, Plasebo
- Keywords
- immunotherapy, lung cancer, probiotics, Bifidobacterium animalis, microbiota
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bifidobacterium animalis subsp. lactis Bl-04Dietary supplement
4 x 10^9 cfu/g/day Bifidobacterium animalis subsp. lactis Bl-04 for 12 weeks
PlaseboOther
1 g/day maltodextrin for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention group will receive an oral dosage of 4 x 10^9 cfu/g/day Bifidobacterium animalis subsp. lactis BL-04 strain (Danisco, USA) and 1 gram of maltodextrin (Danisco, USA) in conjunction with the conventional treatment, which consisted of systemic cancer immunotherapy with nivolumab at a dose of 3 mg/kg administered intravenously every two weeks. The immunotherapy with nivolumab will be completed in twelve weeks.
A probiotic strain is provided to the intervention group in the form of a sachet. Patients will be asked to pour the entire sachet into a glass of water (100 mL, room temperature), mix, and drink it every day for 12 weeks. Receives: Dietary Supplement: Bifidobacterium animalis subsp. lactis Bl-04 |
| Plasebo group | Placebo comparator | The plasebo group will receive the conventional treatment, which consisted of systemic cancer immunotherapy with nivolumab at a dose of 3 mg/kg administered intravenously every two weeks. The immunotherapy with nivolumab will be completed in twelve weeks.
In addition to the traditional treatment (nivolumab), the plasebo group will be given 1 g/day maltodextrin (Danisco, USA) as placebo. Maltodextrin will be provided to the intervention group in the form of a sachet. Patients will be asked to pour the entire sachet into a glass of water (100 mL, room temperature), mix, and drink it every day for 12 weeks. Receives: Other: Plasebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Clinical Response
The clinical impact of the immunotherapy will be evaluated according to RECIST (Response Evaluation Criteria In Solid Tumors) 1.1 criteria based on radiological analysis.
Measured: Week 12
Progression-free survival
The progression-free survival (PFS) period will be defined as the interval between the initiation of treatment and the date of radiological progression.
Measured: Basaline and the date of radiological progression
Overall survival
The overall survival (OS) period will be defined as the interval between the date of disease diagnosis and death from any cause.
Measured: Basaline and the date of death from any case
Secondary outcomes (2)
Intestinal microbiota modulation
Microbiota and fatty acid analyses, including acetic acid, propionic acid, and butyric acid, will be conducted on fecal samples."
Measured: Basaline and Week 12
Immunological findings
The concentrations of CD4+ T cell subgroups (Th1, Th2, Th9, Th17, Th1Th17, and Treg) and sitokins (IL-1β, IL-4, IL-10, IL-17, TNF-α, TGF-beta, IFN-gamma, IL-36 and trimethylamine N-oxide) will be quantified in the serum samples of the patients.
Measured: Basaline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2024
- Study start12 Aug 2024
- Primary completion31 Oct 2025 (estimated)
- Study completion20 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Non-small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Collaborators
- Health Institutes of Turkey
- Responsible party
- Principal investigator, Mehmet Artac, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06428422
- Sponsor's protocol ID
- BL-32769
- Status last verified
- Aug 2024
- First submitted
- 20 May 2024
- Last updated
- 16 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Bifidobacterium Lactis Supplementation on Survival and Treatment Response in Metastatic Non-small Cell Lung Cancer Patients Receiving Immunotherapy (Nivolumab)
- ClinicalTrials.gov ID
- NCT06428422
- Acronym / sponsor ID
- BL-32769
- Conditions
- Metastatic Non-small Cell Lung Cancer
- Keywords
- immunotherapy, lung cancer, probiotics, Bifidobacterium animalis, microbiota
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Collaborators
- Health Institutes of Turkey
- Study start
- 12 Aug 2024 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 24 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Dietary Supplement: Bifidobacterium animalis subsp. lactis Bl-04The intervention group will receive an oral dosage of 4 x 10^9 cfu/g/day Bifidobacterium animalis subsp. lactis BL-04 strain (Danisco, USA) and 1 gram of maltodextrin (Danisco, USA) in conjunction with the conventional treatment, which consisted of systemic cancer immunotherapy with nivolumab at a dose of 3 mg/kg administered intravenously every two weeks. The immunotherapy with nivolumab will be completed in twelve weeks. A probiotic strain is provided to the intervention group in the form of a sachet. Patients will be asked to pour the entire sachet into a glass of water (100 mL, room temperature), mix, and drink it every day for 12 weeks. |
| Plasebo group | Placebo comparator | Other: PlaseboThe plasebo group will receive the conventional treatment, which consisted of systemic cancer immunotherapy with nivolumab at a dose of 3 mg/kg administered intravenously every two weeks. The immunotherapy with nivolumab will be completed in twelve weeks. In addition to the traditional treatment (nivolumab), the plasebo group will be given 1 g/day maltodextrin (Danisco, USA) as placebo. Maltodextrin will be provided to the intervention group in the form of a sachet. Patients will be asked to pour the entire sachet into a glass of water (100 mL, room temperature), mix, and drink it every day for 12 weeks. |
Who may qualify
- Ages
- 19 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bifidobacterium animalis subsp. lactis Bl-044 x 10^9 cfu/g/day Bifidobacterium animalis subsp. lactis Bl-04 for 12 weeks | Dietary supplement | Intervention group |
| Plasebo1 g/day maltodextrin for 12 weeks | Other | Plasebo group |
Primary outcome
Evaluation of Clinical Response
Time frame: Week 12
The clinical impact of the immunotherapy will be evaluated according to RECIST (Response Evaluation Criteria In Solid Tumors) 1.1 criteria based on radiological analysis.
Progression-free survival
Time frame: Basaline and the date of radiological progression
The progression-free survival (PFS) period will be defined as the interval between the initiation of treatment and the date of radiological progression.
Overall survival
Time frame: Basaline and the date of death from any case
The overall survival (OS) period will be defined as the interval between the date of disease diagnosis and death from any cause.
2 secondary outcomes
Intestinal microbiota modulation
Time frame: Basaline and Week 12
Immunological findings
Time frame: Basaline and Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bifidobacterium animalis subsp. lactis Bl-04 and Plasebo in people with Metastatic Non-small Cell Lung Cancer, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mehmet Artaç, MD (+90332236000 ext. 6434, martac@erbakan.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Clinical Response (time frame: Week 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2024.