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

NCT07191171 | Recruiting

• 1 other identifier: 9540
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

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

Keywords

Dysbiosis; Lung cancer; Non-small cell lung cancer; Intestinal microbiota; Immunotherapy

Outcome Measures

Primary Outcomes (1)

• progression-free survival

  90 days preceding D1 of immunotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult (≥18 years) with confirmed diagnosis of NSCLC stage IV or stage III-C NSCLC and under imunotherapy treatment

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Service de Pneumologie - CHU de Strasbourg - France

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Dysbiosis; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Central Study Contacts

Céline MASCAUX, MD, PhD

CONTACT

33.3.69.55.06.39; celine.mascaux@chru-strasbourg.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: September 24, 2025
• Study Start: February 5, 2025
• Primary Completion: February 5, 2026
• Study Completion: February 5, 2026
• Last Updated: September 24, 2025

Record last verified: 2025-04

Locations

FR (1)