Non Small Cell Lung CancerNCT04145232
AImmune - Artificial Intelligence Algorithm for Identification of Immunogenic Neoepitopes of Cancer to Predict and Boost Patient's Response to Immunotherapies.
An observational study of Non Small Cell Lung Cancer and Neoepitopes, run by Ardigen at 1 site in Poland.
Trial summary
The goal of the project is to develop and validate A.I.mmune technology. It performs complex analyses of patients' tumor and immune system state using data derived from next-generation sequencing of tumor and healthy tissue to identify cancer neoantigens, which are likely to elicit an immune response. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer, Neoepitopes, Neoantigens
- What is being tested?
- Collection of biopsy (FFPE), blood (PBMC) and stool
- How many people
- 30 participants
- Where
- 1 sitePoland
- Study dates
- 13 Jun 2019to 30 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Patients receiving routine treatment.
Who may be able to join
- Men or women ≥18 years of age.
- Patients with non-small cell lung cancer.
- Patients with informed consent to participate in the study.
- Patients receiving routine treatment (immunotherapy using anti-PD1 / anti-PDL1 and / or anti CTLA4 antibodies), financed by the Polish National Health Fund (NFZ).
- The applied immunotherapy should be the first or second line of treatment.
Who cannot join
- Patients who are unable to understand, read and / or sign informed consent.
- Patients who can not collect stools.
- Patients with fecal transplant.
- The applied immunotherapy is not the first or second line of treatment.
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
University Clinical Centre in Gdansk
Gdansk
About this study
Official title: Development of AImmune Technology as a Bioinformatic Component of Diagnostic Tests Used in Cancer Immunotherapy
The goal of the project is to develop and validate A.I.mmune technology. It performs complex analyses of patients' tumor and immune system state using data derived from next-generation sequencing of tumor and healthy tissue to identify cancer neoantigens, which are likely to elicit an immune response.
A key challenge to be solved using the technology is to predict for each patient which neoepitopes are not only likely to bind to HLA or be presented on the tumor cell surface, but also will be recognized by the T-cell receptor and create the immunogenic response. The presence of such epitopes is required for immunotherapy by immune checkpoint inhibition to have an effect on the disease. Knowledge of those epitopes enables therapeutic strategies to boost the immune response by designing personalized cancer vaccines and adoptive cell therapies.
The samples and data collected in this clinical study will be used for clinical validation of A.I.mmune technology. For all patients treated with immunotherapy (using anti-PD1 / anti-PDL1 and / or anti-CTLA-4 antibodies) peripheral blood samples (PBMC) and biopsy (FFPE) collection will be performed before treatment. Samples will be sequenced by next-generation sequencing platform. In parallel, the investigators will also collect samples of stool (one sample before the start of immunotherapy) and follow-up information of responses to treatment.
- Conditions
- Non Small Cell Lung Cancer, Neoepitopes, Neoantigens, Immunotherapy, Next Generation Sequencing (NGS), Personalized Neoantigen Cancer Vaccine
- Being tested
- Collection of biopsy (FFPE), blood (PBMC) and stool
- Keywords
- Cancer, Non Small Cell Lung Cancer, Neoepitopes, Neoantigens, Immunotherapy, Nivolumab, Ipilimumab, Atezolizumab, Neoantigen cancer vaccine, Personalized neoantigen cancer vaccine, FFPE, PBMC, Stool, Immuno-Oncology, Next generation sequencing (NGS)
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of biopsy (FFPE), blood (PBMC) and stoolBiological
Also called Nivolumab, Ipilimumab, Atezolizumab
Patients receiving routine treatment (immunotherapy using anti-PD1 / anti-PDL1 and / or anti CTLA4 antibodies), financed by the Polish National Health Fund (NFZ).
| Study group | Role | What they receive |
|---|---|---|
| NSCLC | This cohort will consist of 30 patients with non-small cell lung cancer (NSCLC). Receives: Biological: Collection of biopsy (FFPE), blood (PBMC) and stool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Responders and Non-responders on immunotherapy (evaluated using RECIST 1.1 criteria)
Standard follow-up care after cancer treatment.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2019
- Study start13 Jun 2019
- Primary completion15 Oct 2020 (estimated)
- Study completion30 Nov 2020 (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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ardigen
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Małopolskie Centre of Entrepreneurship
- Responsible party
- Sponsor
- Investigators
- Piotr Stepniak, Principal investigator, Ardigen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04145232
- Sponsor's protocol ID
- A.I.mmune
- Other IDs
- RPMP.01.02.01-12-0301/17
- Status last verified
- Aug 2020
- First submitted
- 29 Oct 2019
- Last updated
- 10 Aug 2020
- 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 10 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of AImmune Technology as a Bioinformatic Component of Diagnostic Tests Used in Cancer Immunotherapy
- ClinicalTrials.gov ID
- NCT04145232
- Acronym / sponsor ID
- A.I.mmune
- Conditions
- Non Small Cell Lung Cancer, Neoepitopes, Neoantigens, Immunotherapy, Next Generation Sequencing (NGS), Personalized Neoantigen Cancer Vaccine
- Keywords
- Cancer, Non Small Cell Lung Cancer, Neoepitopes, Neoantigens, Immunotherapy, Nivolumab, Ipilimumab, Atezolizumab
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- ArdigenIndustry (pharma, biotech, devices)
- Collaborators
- Małopolskie Centre of Entrepreneurship
- Study start
- 13 Jun 2019 (actual)
- Primary completion
- 15 Oct 2020 (estimated)
- Study completion
- 30 Nov 2020 (estimated)
- First posted
- 30 Oct 2019 (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.
The goal of the project is to develop and validate A.I.mmune technology. It performs complex analyses of patients' tumor and immune system state using data derived from next-generation sequencing of tumor and healthy tissue to identify cancer neoantigens, which are likely to elicit an immune response.
A key challenge to be solved using the technology is to predict for each patient which neoepitopes are not only likely to bind to HLA or be presented on the tumor cell surface, but also will be recognized by the T-cell receptor and create the immunogenic response. The presence of such epitopes is required for immunotherapy by immune checkpoint inhibition to have an effect on the disease. Knowledge of those epitopes enables therapeutic strategies to boost the immune response by designing personalized cancer vaccines and adoptive cell therapies.
The samples and data collected in this clinical study will be used for clinical validation of A.I.mmune technology. For all patients treated with immunotherapy (using anti-PD1 / anti-PDL1 and / or anti-CTLA-4 antibodies) peripheral blood samples (PBMC) and biopsy (FFPE) collection will be performed before treatment. Samples will be sequenced by next-generation sequencing platform. In parallel, the investigators will also collect samples of stool (one sample before the start of immunotherapy) and follow-up information of responses to treatment.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NSCLC | – | Biological: Collection of biopsy (FFPE), blood (PBMC) and stoolThis cohort will consist of 30 patients with non-small cell lung cancer (NSCLC). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving routine treatment.
Key inclusion criteria (5 listed)
- Men or women ≥18 years of age.
- Patients with non-small cell lung cancer.
- Patients with informed consent to participate in the study.
- Patients receiving routine treatment (immunotherapy using anti-PD1 / anti-PDL1 and / or anti CTLA4 antibodies), financed by the Polish National Health Fund (NFZ).
- The applied immunotherapy should be the first or second line of treatment.
Key exclusion criteria (4 listed)
- Patients who are unable to understand, read and / or sign informed consent.
- Patients who can not collect stools.
- Patients with fecal transplant.
- The applied immunotherapy is not the first or second line of treatment.
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 |
|---|---|---|
| Collection of biopsy (FFPE), blood (PBMC) and stoolAlso: Nivolumab, Ipilimumab, AtezolizumabPatients receiving routine treatment (immunotherapy using anti-PD1 / anti-PDL1 and / or anti CTLA4 antibodies), financed by the Polish National Health Fund (NFZ). | Biological | NSCLC |
Primary outcome
Number of Responders and Non-responders on immunotherapy (evaluated using RECIST 1.1 criteria)
Time frame: Up to 6 months
Standard follow-up care after cancer treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2020.
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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. This study is not recruiting at the moment.
Piotr Stepniak principal investigator
Ardigen
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 Non Small Cell Lung Cancer and Neoepitopes, run by Ardigen at 1 site in Poland.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 10 Aug 2020. 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 Poland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martyna Balawejder (+48 883 319 890, martyna.balawejder@ardigen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Responders and Non-responders on immunotherapy (evaluated using RECIST 1.1 criteria) (time frame: Up to 6 months). 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 10 Aug 2020; AzTrials last refreshed its copy on 28 Oct 2026.