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NCT07191171Recruiting

Impact of Dysbiosis-inducing Drugs on Effectivity of Immune Checkpoint Inhibitor in Non-small Cell Lung Cancer Patients

Impact of Dysbiosis-inducing Drugs on Effectivity of Immune Checkpoint Inhibitor in Non-small Cell Lung Cancer Patients: a Retrospective Study

Source: ClinicalTrials.gov · Last updated 24 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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)

Status (registry)
Recruiting
Study type
Observational
Enrollment
800 (estimated)
First submitted
7 Apr 2025
Start date
5 Feb 2025
Primary completion date
5 Feb 2026
Lead sponsor
University Hospital, Strasbourg, France
Diseases
Lung cancer
NCT number
NCT07191171

What you commit to

  • Study type: Observational
  • Planned participants: 800
  • From 5 Feb 2025 to the primary completion date, 5 Feb 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Lack of relevant data on concomitant treatments, biology, or clinical outcomes

Other illness

  • Disease stage below stage III-C

Other

  • Refusal to reuse data for scientific research purposes
  • Minor patient
  • Patient included in a clinical trial with an unknown randomization arm (double-blind study)

Who the study is looking for

  • Adult (≥18 years)
  • Confirmed diagnosis of NSCLC
  • Stage IV or stage III-C NSCLC
  • Immunotherapy treatment

Age in the registry: 18 years to - · Sex: All

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Service de Pneumologie - CHU de Strasbourg - France
Coordinator of this site? Confirm its status
StrasbourgFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.