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NCT Number: NCT07191171

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

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)

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service de Pneumologie - CHU de Strasbourg - France

Strasbourg, 67091, France

Location status: Recruiting

Location contact

Anne Dory, MD

SUB_INVESTIGATOR

Bertrand Basil, PhD

SUB_INVESTIGATOR

Céline MASCAUX, MD, PhD

CONTACT

[email protected]

33.3.69.55.06.39

Céline MASCAUX, MD, PhD

PRINCIPAL_INVESTIGATOR

Cézar Matau, MD

SUB_INVESTIGATOR

Erwan Pencreach, PharmD

SUB_INVESTIGATOR

Gourieux Gourieux, PharmD

SUB_INVESTIGATOR

Guillaume Pamart, MD

SUB_INVESTIGATOR

Justine Dumont, MD

SUB_INVESTIGATOR

Koukeb Rougieg, CRA

SUB_INVESTIGATOR

Lucile Pabst, MD

SUB_INVESTIGATOR

Michele Beau-Faller, MD, PhD

SUB_INVESTIGATOR

Quentin Creusot, MD

SUB_INVESTIGATOR

Sarah Fischer, Psychologist

SUB_INVESTIGATOR

Sébastien Lopes, MD

SUB_INVESTIGATOR

Thibaut Goetsch, MD

SUB_INVESTIGATOR

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. progression-free survival

    Time frame: 90 days preceding D1 of immunotherapy

Study contacts

Contact information is provided by the study sponsor or research team.

Céline MASCAUX, MD, PhD

CONTACT

[email protected]

33.3.69.55.06.39

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

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

Acronym: ICI

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 24, 2025
Registry last updated
Sep 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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