Small Cell Lung CarcinomaHYPENCT06558903
Searching for Predictive Biomarkers of Efficacy in Small Cell Lung Cancer Patients Treated With Chemotherapy-immunotherapy Combination Using Imaging Mass Cytometry (HYPE)
An observational study of Small Cell Lung Carcinoma, run by University Hospital, Brest at 1 site in France.
Trial summary
The goal of this retrospective study is to identify predictive biomarkers of efficacy in tumor samples of small cell lung cancer patients treated with chemotherapy-immunotherapy combination using imaging mass cytometry. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Carcinoma
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 24 Jun 2021to 1 Jan 2025
- 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: All patients who started a first line treatment with atezolizumab plus carboplatin and etoposide at Brest University Hospital before February 2021 with available tumor sample before treatment start
Who may be able to join
- Patients with extensive or metastatic small cell lung cancer
- Patients who started a first line treatment with atezolizumab plus carboplatin and etoposide in routine practice before February 2021
- Patients with available tumor sample before treatment start
- No objection from living patients
Who cannot join
- Patients who started first line treatment with atezolizumab plus carboplatin and etoposide in routine practice after February 2021
- Patients having received immunotherapy in a clinical trial
- Patients with auto-immune disorder
- Patients under legal protection (guardianship, curatorship)
- Patients refusing to participate to the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Predictive Biomarkers of Response to Carboplatin Etoposide Atezolizumab Combination in Patients With Small Cell Lung Cancer, Exploratory Study by HYPErionTM Tissue Mass Imaging
The goal of this retrospective study is to identify predictive biomarkers of efficacy in tumor samples of small cell lung cancer patients treated with chemotherapy-immunotherapy combination using imaging mass cytometry. The main question it aims to answer is: is there any feature in the tumour microenvironment that can discriminate responders from non responders before treatment? Participants will provide consent for the collection of their clinical data and the study of their tumor samples
Read the detailed description
Small cell lung cancer patients treated with first-line atezolizumab plus platinum-etoposide regimen with available formalin fixed paraffin embedded (FFPE) biopsies at baseline will be identified from Brest University Hospital medical records and their samples will be retrieved from Brest University Hospital Pathology Laboratory for imaging mass cytometry analyses.
Clinical data will be collected for each patient, including progression-free survival (defined as the time between treatment start and date of progression according to investigator, or death from any cause) and overall survival (defined as the time between treatment start and date of death from any cause).
For imaging mass cytometry analyses, a panel of 39 metal-tagged antibodies will be used to characterize the cell composition of lung tumors at baseline (inflammatory, tumor and stromal cells).
Statistical analyses will be performed to correlate the composition of the tumor microenvironment at baseline and the survival data.
- Conditions
- Small Cell Lung Carcinoma
- Keywords
- Biomarker, Immunotherapy
- Medical subject headings
- Small Cell Lung Carcinoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of predictive biomarkers of anti-PD-L1 efficacy in the tumor of small cell lung cancer patients
Features in the tumour microenvironment that can discriminate patients responding to anti-PD-L1 from non responders
Measured: 3 year
Secondary outcomes (2)
Progression-free survival
Time between treatment start and date of progression according to investigator, or death from any cause
Measured: 3 year
Overall survival
Time between treatment start and date of death from any cause
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start24 Jun 2021
- Primary completion1 Oct 2021
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung CarcinomaStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Margaux Geier, MD, Study director, Department of Medical Oncology, Brest University HospitalPierre Le Noac'h, MD, Principal investigator, Department of Medical Oncology, Brest University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06558903
- Sponsor's protocol ID
- 29BRC21.0110 - HYPE
- Acronym
- HYPE
- Status last verified
- Aug 2024
- First submitted
- 9 Aug 2024
- Last updated
- 19 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Predictive Biomarkers of Response to Carboplatin Etoposide Atezolizumab Combination in Patients With Small Cell Lung Cancer, Exploratory Study by HYPErionTM Tissue Mass Imaging
- ClinicalTrials.gov ID
- NCT06558903
- Acronym / sponsor ID
- HYPE / 29BRC21.0110 - HYPE
- Conditions
- Small Cell Lung Carcinoma
- Keywords
- Biomarker, Immunotherapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 24 Jun 2021 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 19 Aug 2024 (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 this retrospective study is to identify predictive biomarkers of efficacy in tumor samples of small cell lung cancer patients treated with chemotherapy-immunotherapy combination using imaging mass cytometry. The main question it aims to answer is: is there any feature in the tumour microenvironment that can discriminate responders from non responders before treatment? Participants will provide consent for the collection of their clinical data and the study of their tumor samples
Detailed description
Small cell lung cancer patients treated with first-line atezolizumab plus platinum-etoposide regimen with available formalin fixed paraffin embedded (FFPE) biopsies at baseline will be identified from Brest University Hospital medical records and their samples will be retrieved from Brest University Hospital Pathology Laboratory for imaging mass cytometry analyses.
Clinical data will be collected for each patient, including progression-free survival (defined as the time between treatment start and date of progression according to investigator, or death from any cause) and overall survival (defined as the time between treatment start and date of death from any cause).
For imaging mass cytometry analyses, a panel of 39 metal-tagged antibodies will be used to characterize the cell composition of lung tumors at baseline (inflammatory, tumor and stromal cells).
Statistical analyses will be performed to correlate the composition of the tumor microenvironment at baseline and the survival data.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who started a first line treatment with atezolizumab plus carboplatin and etoposide at Brest University Hospital before February 2021 with available tumor sample before treatment start
Key inclusion criteria (4 listed)
- Patients with extensive or metastatic small cell lung cancer
- Patients who started a first line treatment with atezolizumab plus carboplatin and etoposide in routine practice before February 2021
- Patients with available tumor sample before treatment start
- No objection from living patients
Key exclusion criteria (5 listed)
- Patients who started first line treatment with atezolizumab plus carboplatin and etoposide in routine practice after February 2021
- Patients having received immunotherapy in a clinical trial
- Patients with auto-immune disorder
- Patients under legal protection (guardianship, curatorship)
- Patients refusing to participate to the study
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
Identification of predictive biomarkers of anti-PD-L1 efficacy in the tumor of small cell lung cancer patients
Time frame: 3 year
Features in the tumour microenvironment that can discriminate patients responding to anti-PD-L1 from non responders
2 secondary outcomes
Progression-free survival
Time frame: 3 year
Overall survival
Time frame: 3 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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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.
Margaux Geier, MD study director
Department of Medical Oncology, Brest University Hospital
Pierre Le Noac'h, MD principal investigator
Department of Medical Oncology, Brest University Hospital
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 Small Cell Lung Carcinoma, run by University Hospital, Brest 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: status not confirmed, as of the sponsor's last update on 19 Aug 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of predictive biomarkers of anti-PD-L1 efficacy in the tumor of small cell lung cancer patients (time frame: 3 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 19 Aug 2024; AzTrials last refreshed its copy on 7 Nov 2026.