DysbiosisICINCT07191171
Impact of Dysbiosis-inducing Drugs on Effectivity of Immune Checkpoint Inhibitor in Non-small Cell Lung Cancer Patients
An observational study of Dysbiosis, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysbiosis
- How many people
- 800 participants
- Where
- 1 siteFrance
- Study dates
- 5 Feb 2025to 5 Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Adult (≥18 years) with confirmed diagnosis of NSCLC stage IV or stage III-C NSCLC and under imunotherapy treatment
Who may be able to join
- Adult (≥18 years)
- Confirmed diagnosis of NSCLC
- Stage IV or stage III-C NSCLC
- Immunotherapy treatment
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service de Pneumologie - CHU de Strasbourg - France
Strasbourg, 67091
Céline MASCAUX, MD, PhD, 33.3.69.55.06.39, celine.mascaux@chru-strasbourg.fr
Céline MASCAUX, MD, PhD
About this study
Official title: Impact of Dysbiosis-inducing Drugs on Effectivity of Immune Checkpoint Inhibitor in Non-small Cell Lung Cancer Patients: a Retrospective Study
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
- Medical subject headings
- Dysbiosis, Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival
Measured: 90 days preceding D1 of immunotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study start5 Feb 2025
- Primary completion5 Feb 2026 (estimated)
- Study completion5 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysbiosisStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07191171
- Sponsor's protocol ID
- 9540
- Acronym
- ICI
- Status last verified
- Apr 2025
- First submitted
- 7 Apr 2025
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Dysbiosis-inducing Drugs on Effectivity of Immune Checkpoint Inhibitor in Non-small Cell Lung Cancer Patients: a Retrospective Study
- ClinicalTrials.gov ID
- NCT07191171
- Acronym / sponsor ID
- ICI / 9540
- Conditions
- Dysbiosis
- Keywords
- Dysbiosis, Lung cancer, Non-small cell lung cancer, Intestinal microbiota, Immunotherapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 5 Feb 2025 (actual)
- Primary completion
- 5 Feb 2026 (estimated)
- Study completion
- 5 Feb 2026 (estimated)
- First posted
- 24 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult (≥18 years) with confirmed diagnosis of NSCLC stage IV or stage III-C NSCLC and under imunotherapy treatment
Key inclusion criteria (4 listed)
- Adult (≥18 years)
- Confirmed diagnosis of NSCLC
- Stage IV or stage III-C NSCLC
- Immunotherapy treatment
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
progression-free survival
Time frame: 90 days preceding D1 of immunotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dysbiosis, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Céline MASCAUX, MD, PhD (33.3.69.55.06.39, celine.mascaux@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression-free survival (time frame: 90 days preceding D1 of immunotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.