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

NCT ID: NCT07191171

Last Updated: 2025-09-24

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 800 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-02-05
• Study Completion Date: 2026-02-05

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)

Conditions

Dysbiosis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Strasbourg, France

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Service de Pneumologie - CHU de Strasbourg - France

Strasbourg, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Céline MASCAUX, MD, PhD

Role: CONTACT

celine.mascaux@chru-strasbourg.fr

33.3.69.55.06.39

Facility Contacts

Céline MASCAUX, MD, PhD

Role: primary

celine.mascaux@chru-strasbourg.fr

33.3.69.55.06.39

Other Identifiers

9540

Identifier Type: -

Identifier Source: org_study_id