How medications that change gut bacteria affect immunotherapy in advanced non-small cell lung cancer
Official title: Impact of Dysbiosis-inducing Drugs on Effectivity of Immune Checkpoint Inhibitor in Non-small Cell Lung Cancer Patients: a Retrospective Study
Run by University Hospital, Strasbourg, France · NCT07191171 · Data updated 2026-11-12
This study tries to see if drugs that alter the gut microbiome change how well immunotherapy works in adults with stage III-C or IV non-small cell lung cancer.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 800 (estimated) |
| Sponsor | University Hospital, Strasbourg, France Academic / other |
| Drugs / interventions | Immunotherapy |
| Locations | 1 site (Strasbourg) |
| Status | Recruiting |
| Started | February 5, 2025 |
| Main results expected | February 5, 2026 |
| Study ends | February 5, 2026 |
| Registry record updated | September 24, 2025 |
| Trial ID | NCT07191171 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with confirmed stage III-C or IV non-small cell lung cancer who are receiving immunotherapy at CHU Strasbourg and who consent to use of their clinical data.
✕Probably not a fit
Patients with early-stage disease, those not receiving immunotherapy, those lacking adequate medical records, or those enrolled in double-blind randomized trials with unknown treatment arms are unlikely to benefit from the study's findings.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational project will review medical records of adult patients with stage III-C or IV non-small cell lung cancer who are receiving immunotherapy at CHU Strasbourg. Investigators will collect information on concomitant medications known to alter the intestinal microbiota, available biological or microbiome data, and clinical outcomes including response to immune checkpoint inhibitors and survival. The analysis will look for associations between exposure to dysbiosis-inducing drugs (for example antibiotics or proton pump inhibitors) and treatment response while adjusting for clinical and demographic confounders. Patients enrolled in blinded randomized trials or those lacking key treatment or outcome data will be excluded.
Why it matters
Potential benefit: If successful, the findings could identify commonly prescribed medications that reduce immunotherapy effectiveness and guide clinicians to modify co-treatments to improve patient outcomes.
How similar studies have gone: Previous observational and translational studies have linked gut microbiome composition and exposures such as antibiotics or proton pump inhibitors to immune checkpoint inhibitor responses, but causality and clear clinical recommendations remain unproven.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Service de Pneumologie - CHU de Strasbourg - France
Strasbourg, France Recruiting
Study contacts
- Study coordinator: Céline MASCAUX, MD, PhD
- Email: celine.mascaux@chru-strasbourg.fr
- Phone: 33.3.69.55.06.39
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.