Lung Cancer MetastaticIMMUNO-SUPNCT03595813
Identifying Immune-related Biomarkers to Predict the Efficacy of Cancer Immunotherapy
A study testing Blood sample collection and Biopsy collection in people with Lung Cancer Metastatic and Locally Advanced Malignant Neoplasm, run by Institut Paoli-Calmettes at 1 site in France.
Trial summary
The development of Immune Checkpoint Blockade (ICB) is a revolution in medical oncology as ICB have changed the standard treatments of several metastatic tumor types. However, the response rate to ICB is low, and the biological bases for this response heterogeneity are poorly understood. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer Metastatic, Locally Advanced Malignant Neoplasm, Non Hodgkin Lymphoma
- What is being tested?
- Blood sample collection and Biopsy collection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteFrance
- Study dates
- 29 Jan 2018to 25 Jun 2025
- Phase
- Interventional
- 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
Who may be able to join
- Age > 18 years
- Diagnosis of locally advanced or metastatic solid tumor or lymphoma treated with Immune check blockade
- Signed informed consent
- Affiliated to(or beneficiary of) the French Social Security
Who cannot join
- Pregnant or breastfeeding woman or woman who does not apply effective contraception
- Emergency
- Vulnerable person or unable to provide informed consent
- Emergency
- Person unable to comply with required study follow up
- Contraindication to the study procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identifying Immune-related Biomarkers to Predict the Efficacy of Cancer Immunotherapy-IMMUNO-SUP-IPC 2017-002
The development of Immune Checkpoint Blockade (ICB) is a revolution in medical oncology as ICB have changed the standard treatments of several metastatic tumor types. However, the response rate to ICB is low, and the biological bases for this response heterogeneity are poorly understood.
In the frame of Immunosup study, we will collect blood (at baseline, post infusion of ICB n°2/4/8 and at progression) and tumor samples (optional: at baseline and progression) from patients with locally advanced or metastatic cancer, treated with ICB, in order to determine if the dynamics of immunosuppressive actors (MDSC, TReg, Immunosuppressive cytokines) predicts response to these immunotherapies.
- Conditions
- Lung Cancer Metastatic, Locally Advanced Malignant Neoplasm, Non Hodgkin Lymphoma, Urologic Neoplasms
- Being tested
- Blood sample collection, Biopsy collection
- Keywords
- Immune check point blockade, biomarkers, immunomonitoring
- Medical subject headings
- Lymphoma, Non-Hodgkin, Urologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample collectionProcedure or surgery
Blood samples collection (5EDTA vials) at baseline, post infusion of ICB n°2/4/8 and at progression
Biopsy collectionProcedure or surgery
Optional biopsy collection at baseline and progression
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with Immune Checkpoint Blockade | Experimental | Not described Receives: Procedure: Blood sample collection; Procedure: Biopsy collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Plasma immunosuppressive actors in patients treated with a Checkpoint inhibitor
Measure (by flux cytometry) and comparison of plasma immunosuppressive actors, between baseline and the 4th injection of an Immune Checkpoint inhibitor
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2018
- Study start29 Jan 2018
- Primary completion17 Jul 2020
- Study completion25 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung Cancer MetastaticStudies of the same condition, open and under way.
- More trials run by Institut Paoli-CalmettesThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Research Center of Marseille
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03595813
- Sponsor's protocol ID
- IMMUNO-SUP-IPC 2017-002
- Acronym
- IMMUNO-SUP
- Status last verified
- Apr 2026
- First submitted
- 11 Jul 2018
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rochigneux P, Lisberg A, Garcia A, Granjeaud S, Madroszyk A, Fattori S, Goncalves A, Devillier R, Maby P, Salem N, Gorvel L, Chanez B, Gukasyan J, Carroll J, Goldman J, Chretien AS, Olive D, Garon EB. Mass Cytometry Reveals Classical Monocytes, NK Cells, and ICOS+ CD4+ T Cells Associated with Pembrolizumab Efficacy in Patients with Lung Cancer. Clin Cancer Res. 2022 Dec 1;28(23):5136-5148. doi: 10.1158/1078-0432.CCR-22-1386.
PubMed 36166003
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Immune-related Biomarkers to Predict the Efficacy of Cancer Immunotherapy-IMMUNO-SUP-IPC 2017-002
- ClinicalTrials.gov ID
- NCT03595813
- Acronym / sponsor ID
- IMMUNO-SUP / IMMUNO-SUP-IPC 2017-002
- Conditions
- Lung Cancer Metastatic, Locally Advanced Malignant Neoplasm, Non Hodgkin Lymphoma, Urologic Neoplasms
- Keywords
- Immune check point blockade, biomarkers, immunomonitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Collaborators
- Cancer Research Center of Marseille
- Study start
- 29 Jan 2018 (actual)
- Primary completion
- 17 Jul 2020 (actual)
- Study completion
- 25 Jun 2025 (actual)
- First posted
- 23 Jul 2018 (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 development of Immune Checkpoint Blockade (ICB) is a revolution in medical oncology as ICB have changed the standard treatments of several metastatic tumor types. However, the response rate to ICB is low, and the biological bases for this response heterogeneity are poorly understood.
In the frame of Immunosup study, we will collect blood (at baseline, post infusion of ICB n°2/4/8 and at progression) and tumor samples (optional: at baseline and progression) from patients with locally advanced or metastatic cancer, treated with ICB, in order to determine if the dynamics of immunosuppressive actors (MDSC, TReg, Immunosuppressive cytokines) predicts response to these immunotherapies.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated with Immune Checkpoint Blockade | Experimental | Procedure: Blood sample collection, Procedure: Biopsy collection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 years
- Diagnosis of locally advanced or metastatic solid tumor or lymphoma treated with Immune check blockade
- Signed informed consent
- Affiliated to(or beneficiary of) the French Social Security
Key exclusion criteria (6 listed)
- Pregnant or breastfeeding woman or woman who does not apply effective contraception
- Emergency
- Vulnerable person or unable to provide informed consent
- Emergency
- Person unable to comply with required study follow up
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 |
|---|---|---|
| Blood sample collectionBlood samples collection (5EDTA vials) at baseline, post infusion of ICB n°2/4/8 and at progression | Procedure or surgery | Patients treated with Immune Checkpoint Blockade |
| Biopsy collectionOptional biopsy collection at baseline and progression | Procedure or surgery | Patients treated with Immune Checkpoint Blockade |
Primary outcome
Evaluation of Plasma immunosuppressive actors in patients treated with a Checkpoint inhibitor
Time frame: 4 months
Measure (by flux cytometry) and comparison of plasma immunosuppressive actors, between baseline and the 4th injection of an Immune Checkpoint inhibitor
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Results publication: PubMed 36166003Rochigneux P, Lisberg A, Garcia A, Granjeaud S, Madroszyk A, Fattori S, Goncalves A, Devillier R, Maby P, Salem N, Gorvel L, Chanez B, Gukasyan J, Carroll J, Goldman J, Chretien AS, Olive D, Garon EB. Mass Cytometry Reveals Classical Monocytes, NK Cells, and ICOS+ CD4+ T Cells Associated with Pembrolizumab Efficacy in Patients with Lung Cancer. Clin Cancer Res. 2022 Dec 1;28(23):5136-5148. doi: 10.1158/1078-0432.CCR-22-1386.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample collection and Biopsy collection in people with Lung Cancer Metastatic and Locally Advanced Malignant Neoplasm, run by Institut Paoli-Calmettes 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 6 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: finished, as of the sponsor's last update on 21 Apr 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluation of Plasma immunosuppressive actors in patients treated with a Checkpoint inhibitor (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03595813, which also lists 1 linked publication.
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 21 Apr 2026.