NCT06428422 The Impact of Probiotic on Survival and Treatment Response in Metastatic Non-small Cell Lung Cancer Patients
| NCT ID | NCT06428422 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Necmettin Erbakan University |
| Condition | Metastatic Non-small Cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-08-12 |
| Primary Completion | 2025-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2024-08-12 with a primary completion date of 2025-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06428422 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, up to 90 Years, studying Metastatic Non-small Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06428422 currently recruiting?
Yes, NCT06428422 is actively recruiting participants. Contact the research team at martac@erbakan.edu.tr for enrollment information.
Where is the NCT06428422 trial being conducted?
This trial is being conducted at Konya, Turkey (Türkiye).
Who is sponsoring the NCT06428422 clinical trial?
NCT06428422 is sponsored by Necmettin Erbakan University. The trial plans to enroll 100 participants.
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