Non Small Cell Lung CancerCERBERONCT07815873
Gut Microbiome in Patients With Lung and Melanoma Cancer and Intestinal Microbiota in Gynecologic Cancers
A study testing sample collection in people with Non Small Cell Lung Cancer and Melanoma (Skin Cancer), run by European Institute of Oncology at 1 site in Italy.
Trial summary
This study aims to investigate the role of the gut microbiota and its derived factors, including bacterial-associated antigens that mimic tumor-associated antigens, in predicting response to immune checkpoint inhibitor immunotherapies in patients with various types of cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer, Melanoma (Skin Cancer), Endometrial Cancer
- What is being tested?
- sample collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2026to 1 Apr 2031
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Previous chemotherapy (< 28 days washout), radiation therapy, immunotherapy, or biologic therapy
- Any major surgery within the last 3 weeks
- Pregnant or lactating female
- Unwillingness or inability to follow the procedures
- Grade 3 and 4 adverse event conditioning ICB interruption
- Known oncogene-addicted NSCLC, with the exception of KRAS G12C and BRAF V600E mutant NSCLC Any serious or uncontrolled medical disorder
Show all 22Show fewer
- Prior malignancy active within the previous 2 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast with local control measures (surgery, radiation).
- Patients with active, known or suspected autoimmune disease such as Inflammatory Bowel Disease, Lupus, etc. or other conditions requiring systemic corticosteroids or other systemic immunosuppressive medications.
- Patients with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration.
- Prior treatment with an anti-PD-1, anti-PD-L1 or anti-CTLA-4 antibody.
- Antibiotic or antimycotic medications within 45 days from the beginning of ICB
- Positive test result for hepatitis B or C virus
- Human immunodeficiency virus or known acquired immunodeficiency syndrome
- Concomitant Medications/Vaccinations: medications or vaccinations specifically prohibited in the exclusion criteria are not allowed during the ongoing study. If there is a clinical indication for one of these or other medications or vaccinations specifically prohibited during the study that the investigator considers necessary for a subject's welfare, it will be administered at the discretion of the investigator in keeping with the community standards of medical care. All concomitant medication (within 28 days before the first dose) will be recorded on the case report form (CRF).
- Patients are prohibited from receiving the following therapies during the Screening and Treatment Phase (including retreatment for post-complete response relapse) of this study:
- Immunotherapy not specified in this protocol
- Chemotherapy not specified in this protocol
- other Investigational agents
- Radiation therapy
- Live vaccines within 30 days prior to the first dose of trial treatment and while participating in the trial. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster, yellow fever, rabies, BCG, and typhoid vaccine.
- Systemic glucocorticoids for any purpose other than to modulate symptoms from an event of clinical interest of suspected immunologic aetiology. The use of physiologic doses of corticosteroids may be approved after consultation with the Sponsor.
- Patients who, in the assessment by the investigator, require the use of any of the aforementioned treatments for clinical management should be removed from the study. Patients may receive other medications that the investigator deems to be medically necessary. The Exclusion Criteria describes other medications which are prohibited in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Giulia Sedda, PhD contact
Italy1 site
Istituto europeo di oncologia
Milan, MI, 20141
Luigi Nezi, PhD, +39 02 94375171, luigi.nezi@ieo.it
Giuli Sedda, PhD, +390294372178, giulia.sedda@ieo.it
About this study
Official title: Leveraging Gut Microbiome and Immune System Dynamics During Immunotherapy to Develop Biomarkers of Response in Patients With Lung and Melanoma Cancer' and 'Intestinal Microbiota Profiling in Gynecologic Cancers to Identify Response-relevant Factors During Immune Checkpoint Blockade'
This study aims to investigate the role of the gut microbiota and its derived factors, including bacterial-associated antigens that mimic tumor-associated antigens, in predicting response to immune checkpoint inhibitor immunotherapies in patients with various types of cancer. The aim is to explore whether gut microbiota-mediated immunological modulation is specific to the tumor being treated and whether it can be used to enhance antitumor response.
- Being tested
- sample collection
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Melanoma, Endometrial Neoplasms, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sample collectionBiological
Clinical and radiological assessment will be performed at the enrollment and every 3 +/- 1 months. Clinical information and biological samples will be collected also at 2 years from surgery or start of therapy. We plan collection of a maximum of 13 faecal and blood samples per patient (1 baseline + a maximum of 11 during treatment ± 1 disease progression, ± 10%). In addition, we expect to collect fresh stools and tissue biopsies from at least 3-5 patients per group every year, which will be dedicated to our translational studies.
| Study group | Role | What they receive |
|---|---|---|
| Biological Sample collection | Experimental | Biological Sample Receives: Biological: sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endopoint
Correlation between Bacterial Antigens Mimicking-Tumor associated antigens (BAM-Ts) and clinical response to Immune Checkpoint Blockade (ICB).
Measured: 1 year
Secondary outcomes (1)
Secondary Endpoints
- Correlation between circulating immunological factors during ICB and clinical response: Relapse-Free Survival (RFS) or Progression Free Survival (PFS), Overall Response Rate (ORR), Overall Survival (OS);
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Apr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luigi Nezi, PhD, Principal investigator, Istituto Europeo di OncologiaMonica Casiraghi, MD PhD, Principal investigator, Istituto Europeo di Oncologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07815873
- Sponsor's protocol ID
- UID 4840
- Other IDs
- L2-614
- Acronym
- CERBERO
- Status last verified
- Jul 2026
- First submitted
- 24 Jul 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will insert all information into the paper.
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leveraging Gut Microbiome and Immune System Dynamics During Immunotherapy to Develop Biomarkers of Response in Patients With Lung and Melanoma Cancer' and 'Intestinal Microbiota Profiling in Gynecologic Cancers to Identify Response-relevant Factors During Immune Checkpoint Blockade'
- ClinicalTrials.gov ID
- NCT07815873
- Acronym / sponsor ID
- CERBERO / UID 4840
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Apr 2031 (estimated)
- First posted
- 11 Sep 2026 (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.
This study aims to investigate the role of the gut microbiota and its derived factors, including bacterial-associated antigens that mimic tumor-associated antigens, in predicting response to immune checkpoint inhibitor immunotherapies in patients with various types of cancer. The aim is to explore whether gut microbiota-mediated immunological modulation is specific to the tumor being treated and whether it can be used to enhance antitumor response.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biological Sample collection | Experimental | Biological: sample collectionBiological Sample |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (22 listed)
- Previous chemotherapy (< 28 days washout), radiation therapy, immunotherapy, or biologic therapy
- Any major surgery within the last 3 weeks
- Pregnant or lactating female
- Unwillingness or inability to follow the procedures
- Grade 3 and 4 adverse event conditioning ICB interruption
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sample collectionClinical and radiological assessment will be performed at the enrollment and every 3 +/- 1 months. Clinical information and biological samples will be collected also at 2 years from surgery or start of therapy. We plan collection of a maximum of 13 faecal and blood samples per patient (1 baseline + a maximum of 11 during treatment ± 1 disease progression, ± 10%). In addition, we expect to collect fresh stools and tissue biopsies from at least 3-5 patients per group every year, which will be dedicated to our translational studies. | Biological | Biological Sample collection |
Primary outcome
Primary Endopoint
Time frame: 1 year
Correlation between Bacterial Antigens Mimicking-Tumor associated antigens (BAM-Ts) and clinical response to Immune Checkpoint Blockade (ICB).
1 secondary outcome
Secondary Endpoints
Time frame: 2 year
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 11 Sep 2026.
- Individual participant dataSharing planned: Yes. We will insert all information into the paper.
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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.
Giulia Sedda, PhD contact
Luigi Nezi, PhD principal investigator
Istituto Europeo di Oncologia
Monica Casiraghi, MD PhD principal investigator
Istituto Europeo di Oncologia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sample collection in people with Non Small Cell Lung Cancer and Melanoma (Skin Cancer), run by European Institute of Oncology at 1 site in Italy.
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 0 inclusion and 22 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: opening soon, as of the sponsor's last update on 11 Sep 2026. 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 Italy. 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 Luigi Nezi, PhD (+39 02 94375171, luigi.nezi@ieo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Endopoint (time frame: 1 year). 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 11 Sep 2026.