Actively Recruiting

Age: 18Years +
All Genders
NCT07191171

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

Led by University Hospital, Strasbourg, France · Updated on 2025-09-24

800

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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)

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult (≥18 years)
  • Confirmed diagnosis of NSCLC
  • Stage IV or stage III-C NSCLC
  • Immunotherapy treatment
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

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Trial Site Locations

Total: 1 location

1

Service de Pneumologie - CHU de Strasbourg - France

Strasbourg, France, 67091

Actively Recruiting

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Research Team

C

Céline MASCAUX, MD, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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