NCT07191171 Impact of Dysbiosis-inducing Drugs on Effectivity of Immune Checkpoint Inhibitor in Non-small Cell Lung Cancer Patients
| NCT ID | NCT07191171 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Strasbourg, France |
| Condition | Dysbiosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 800 participants |
| Start Date | 2025-02-05 |
| Primary Completion | 2026-02-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 800 participants in total. It began in 2025-02-05 with a primary completion date of 2026-02-05.
⚠ 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
Lung cancer is the leading cancer in France in terms of mortality. The prognosis of the disease is closely correlated with the diagnostic stage and the majority of patients are diagnosed at a metastatic stage. The arrival of immunotherapy has made it possible to change the therapeutic paradigm by significantly improving the survival of metastatic patients. Despite this progress, only 20 to 30% of patients respond to immunotherapy. The search for predictive factors of response to or resistance to these drugs is of major importance for better patient selection. Among these factors, the intestinal microbiota appears to be closely correlated with the response to immunotherapy via the education of adaptive anticancer immunity. Thus, several bacterial species have been associated with patient survival or disease progression. Interestingly, the abundance of these same bacteria can be modulated by certain drugs co-prescribed with immunotherapy. These dysbiotic treatments or those leading to a significant modification of the composition of the intestinal microbiota could then modulate the response to immunotherapy and therefore patient survival. The objective of this study is therefore to objectify the impact of several therapeutic classes modifying the intestinal microbiota initiated in the 90 days preceding D1 of immunotherapy on the survival of patients with locally advanced (stage III-C) or metastatic (stage IV) non-small cell lung cancer (NSCLC)
Eligibility Criteria
Inclusion Criteria: * Adult (≥18 years) * Confirmed diagnosis of NSCLC * Stage IV or stage III-C NSCLC * Immunotherapy treatment Exclusion Criteria: * Refusal to reuse data for scientific research purposes * Minor patient * Disease stage below stage III-C * Patient included in a clinical trial with an unknown randomization arm (double-blind study) * Lack of relevant data on concomitant treatments, biology, or clinical outcomes
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07191171 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Dysbiosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07191171 currently recruiting?
Yes, NCT07191171 is actively recruiting participants. Contact the research team at celine.mascaux@chru-strasbourg.fr for enrollment information.
Where is the NCT07191171 trial being conducted?
This trial is being conducted at Strasbourg, France.
Who is sponsoring the NCT07191171 clinical trial?
NCT07191171 is sponsored by University Hospital, Strasbourg, France. The trial plans to enroll 800 participants.