Non-Small Cell Lung CancerEVpredictNCT07376512
Predicting Response to Anti-PD-1/PD-L1 Immunotherapy by Plasma Extracellular Vesicle Analysis
An observational study of Non-Small Cell Lung Cancer and Melanoma (Skin Cancer), run by Centre Georges Francois Leclerc at 5 sites in France.
Trial summary
The objective of this prospective multicenter study is to evaluate whether the analysis of immunological biomarkers present in circulating extracellular vesicles is associated with the response to anti-PD-1/PD-L1 treatments in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) or… 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)
- How many people
- 378 participants
- Where
- 5 sitesFrance
- Study dates
- 1 Nov 2026to 1 Nov 2030
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with non-small cell lung cancer (NSCLC) or melanoma, locally advanced or metastatic, and unresectable. For all patients, first-line standard treatment will be based on standard care with an anti-PD-(L)1 therapy, either as monotherapy or in combination (with other immune checkpoint inhibitors or chemotherapy). Standard treatments are defined by the approved indications (marketing authorizations) in France.
Who may be able to join
- Age ≥18 years.
- Histologically confirmed diagnosis of non-small cell lung cancer (NSCLC) or locally advanced/metastatic unresectable melanoma.
- Patient scheduled to initiate anti-PD-(L)1 therapy, either as monotherapy or in combination (other immune checkpoint inhibitors, chemotherapy, etc.).
- Baseline tumor assessment performed within 28 days prior to enrollment (CT scan of thorax, abdomen, and pelvis) with at least one measurable lesion according to RECIST 1.1 criteria.
- Life expectancy >6 months.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at enrollment.
- Patient able to provide informed consent and comply with study procedures.
- Patient covered by a social security system or equivalent.
Who cannot join
- Prior treatment with immunotherapy.
- Presence of EGFR or ALK mutation (applicable only to the lung cohort).
- Presence of another synchronous malignancy.
- Diagnosis of uveal melanoma.
- Treatment with systemic immunosuppressants, including within 28 days prior to enrollment, or corticosteroids >10 mg/day, including within 14 days prior to enrollment.
- Disease not measurable according to RECIST 1.1 criteria.
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- Positive serology for HIV, HBV, or HCV.
- Pregnant or breastfeeding women.
- Inability to comply with study follow-up and visits for geographic, social, or psychological reasons.
- Individuals deprived of liberty or under legal guardianship (including curatorship).
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
France5 sites, 5 recruiting
- Not yet recruiting
CHU Besançon - Service Dermatologie
Besançon, 25000
Charlée CN NARDIN, Doctor, 03 70 63 20 05, cnardin@chu-besancon.fr
- Not yet recruiting
CHU Besançon - Service Pneumologie Oncologie Thoracique
Besançon, 25000
Guillaume GE EBERST, Doctor, 03 70 63 22 06, geberst@chu-besancon.fr
- Recruiting
Centre Georges-François Leclerc
Dijon, 21000
Courèche CK KADERBHAI, Doctor, 03 80 73 75 28, CGKaderbhai@cgfl.fr
- Recruiting
CHU Dijon - Service Oncologie Médicale
Dijon, 21000
Ayoube AZ ZOUAK, Doctor, 03 80 29 58 64, ayoube.zouak@chu-dijon.fr
- Not yet recruiting
Centre Leon Berard - Service Oncologie Médicale
Lyon, 69000
Mona MA AMINI-ADLE, Doctor, 04 78 78 59 96, mona.amini-adle@lyon.unicancer.fr
About this study
The objective of this prospective multicenter study is to evaluate whether the analysis of immunological biomarkers present in circulating extracellular vesicles is associated with the response to anti-PD-1/PD-L1 treatments in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) or unresectable melanoma.
Patients will receive standard-of-care treatment and will be followed according to routine clinical practice. The study involves the collection of four study-specific blood samples at different time points during follow-up, as well as the collection of standard immunohistochemistry results, thoraco-abdomino-pelvic CT scans, and tumor DNA genotyping analyses performed as part of routine care.
Read more
The study aims to determine:
- whether baseline biomarkers in extracellular vesicles are associated with response to anti-PD-1/PD-L1 treatment,
- how these biomarkers change over the course of treatment, and
- to provide exploratory data for the development of predictive immunological response signatures.
Read the detailed description
Immune checkpoint inhibitors (anti-PD-1/PD-L1) have become standard treatment for patients with advanced or metastatic non-small cell lung cancer (NSCLC) or melanoma. However, not all patients respond to these therapies, and current biomarkers are imperfect.
Circulating extracellular vesicles (EVs) are nanovesicles derived from tumor and immune cells, carrying proteins, nucleic acids, and lipids. They represent an accessible and stable source of immunological biomarkers, allowing monitoring of the tumor microenvironment without additional invasive procedures.
This prospective multicenter study aims to determine, in a prospective cohort of patients with locally advanced or metastatic lung cancer or melanoma, the impact of baseline immune biomarkers present in extracellular vesicles on response to anti-PD-(L)1 therapy
Secondary objectives have also been defined :
- To evaluate the association between longitudinal changes in EV-associated immune biomarkers during follow-up and response to anti-PD-(L)1 therapy.
- To develop a predictive score (immune signature) of response to anti-PD-(L)1 therapy by combining baseline EV-associated immune biomarkers.
- To stratify analyses by tumor type (NSCLC versus melanoma) to determine whether tumor-specific characteristics influence the predictive performance of the identified immune signature.
- To obtain preliminary evidence on the contribution of EV-associated biomarkers to the prediction of primary or secondary resistance to anti-PD-(L)1 therapy.
- In the NSCLC cohort, to compare the predictive performance of the EV-based score with that of a score based solely on the tumor expression (assessed on biopsy specimens) of immunosuppressive proteins, without incorporating EV-associated biomarkers, for predicting best overall response (BOR) at 6 months.
- To explore EV-derived miRNA profiles in responders and non-responders.
- In each cohort, to compare the predictive performance of the EV-based score with that of a score integrating tumor mutational biomarkers derived from ctDNA and/or tumor tissue DNA for predicting BOR at 6 months.
- To evaluate PFS, including PFS at 6 and 12 months, as well as median PFS.
- To establish a prospective plasma biobank from patients treated with anti-PD-(L)1 therapies for future retrospective analyses following completion of the EVpredict study in the field of cancer immunology
Study procedures for participants include:
- Blood sample collection: Four study-specific blood draws performed during standard treatment or tumor assessment visits (baseline, 2nd administration, first evaluation, second evaluation).
- Collection of additional information: Standard immunohistochemistry results thoraco-abdomino-pelvic CT scans; circulating or tumor DNA genotyping analyses.
- Clinical follow-up: Conducted according to routine care standards, with no changes to treatment or additional study-specific visits.
- Conditions
- Non-Small Cell Lung Cancer, Melanoma (Skin Cancer)
- Keywords
- standard treatment with anti-PD-(L)1 monotherapy or combination therapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Advanced NSCLC or Melanoma - Anti-PD-(L)1 Therapy | This cohort includes patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) or inoperable melanoma who are receiving standard-of-care anti-PD-1 or anti-PD-L1 therapy, either as monotherapy or in combination with other approved therapies. Participants will follow standard clinical management, and study-specific procedures include four blood draws for extracellular vesicle (EV) analysis at baseline and during follow-up, collection of standard immunohistochemistry results (PD-1, PD-L1, CTLA-4, Tim-3, LAG-3, TIGIT), thoraco-abdominopelvic CT imaging, and tumor DNA genotyping performed as part of routine care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target protein levels in plasma-derived extracellular vesicles (EVs) measured by multiplex ELISA before treatment
Treatment response assessed as Best Overall Response (BOR: complete or partial response per RECIST 1.1) within 6 months.
Measured: 6 months from treatment initiation
Secondary outcomes (9)
Association of EV-Associated Target Protein Concentrations With Best Overall Response at 6 Months
Measured: Baseline to 6 months after treatment initiation
Development of a Predictive Score Based on Baseline EV-Associated Biomarkers for Best Overall Response at 6 Months
Measured: Baseline to 6 months after treatment initiation
Predictive Performance of the EV-Based Score for Best Overall Response
Predictive performance will be assessed using the area under the receiver operating characteristic curve (AUC) and, following score dichotomization, sensitivity and specificity. Performance for predicting BOR will be evaluated in the overall cohort and separately in the NSCLC and melanoma cohorts.
Measured: At 6 months after treatment initiation
EV-Associated Target Protein Concentrations in Non-Responders to Anti-PD-(L)1 Therapy
Analysis of target protein concentrations in EVs at baseline and during follow-up in non-responders according to RECIST 1.1 criteria. These preliminary data will provide an initial assessment of the feasibility of a future clinical trial evaluating the therapeutic benefit of EV analysis for guiding treatment decisions regarding immune checkpoint inhibitor combination therapies in patients with solid tumors.
Measured: Baseline to 6 months after treatment initiation
Comparison of the Predictive Performance of Tumor Immunohistochemistry and the EV-Based Score in the NSCLC Cohort
In the NSCLC cohort, immunohistochemical (IHC) analysis of target protein expression (including PD-L1) will be performed on diagnostic tumor biopsy specimens. The predictive performance of this approach will be compared with that of the EV-based score using receiver operating characteristic (ROC) curve analyses and the AUC.
Measured: Baseline to 6 months after treatment initiation
Comparison of EV-Derived miRNA Expression Profiles Between Responders and Non-Responders
EV-derived miRNA expression profiles at baseline and during follow-up will be analyzed by RT-qPCR and compared between responders and non-responders.
Measured: Baseline to 6 months after treatment initiation
Comparison of the Predictive Performance of Tumor DNA Biomarkers and the EV-Based Score
Analysis of tumor DNA, including ctDNA and/or tumor tissue DNA, will be performed by next-generation sequencing (NGS) at diagnosis and at disease progression. The predictive performance of these biomarkers will be compared with that of the EV-based score using ROC curve analyses and the corresponding AUC.
Measured: At diagnosis and at disease progression; BOR assessed at 6 months after treatment initiation
Progression-Free Survival (PFS) at 6 and 12 Months and Median PFS
PFS will be defined as the time from study inclusion to disease progression, as assessed according to RECIST 1.1 criteria, or death from any cause, whichever occurs first. Patients who are alive without documented progression will be censored at the date of their last known follow-up. Median PFS, as well as PFS rates at 6 and 12 months, will be described
Measured: From the date of enrollment in the study until the first occurrence of disease progression or death, or up to 12 months after enrollment
Storage of Residual Plasma Samples for Future Retrospective Analyses
Residual plasma samples remaining after completion of the study-specific analyses will be stored for future retrospective analyses in participants who have provided consent for biological sample collection. Additional and more in-depth analyses of biomarkers of interest may be performed based on the results generated during the EVpredict study.
Measured: Up to 15 years after the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Nov 2030 (estimated)
- Study completion1 Nov 2030 (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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 378 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Georges Francois Leclerc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jessica JG GOBBO, Clinical Research Scientist, Study chair, Centre Georges François Leclerc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07376512
- Sponsor's protocol ID
- 2025-A01783-46
- Acronym
- EVpredict
- Status last verified
- Oct 2026
- First submitted
- 22 Jan 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Response to Anti-PD-1/PD-L1 Immunotherapy by Plasma Extracellular Vesicle Analysis
- ClinicalTrials.gov ID
- NCT07376512
- Acronym / sponsor ID
- EVpredict / 2025-A01783-46
- Conditions
- Non-Small Cell Lung Cancer, Melanoma (Skin Cancer)
- Keywords
- standard treatment with anti-PD-(L)1 monotherapy or combination therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 378 participants (estimated)
- Lead sponsor
- Centre Georges Francois LeclercUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Nov 2030 (estimated)
- Study completion
- 1 Nov 2030 (estimated)
- First posted
- 29 Jan 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.
The objective of this prospective multicenter study is to evaluate whether the analysis of immunological biomarkers present in circulating extracellular vesicles is associated with the response to anti-PD-1/PD-L1 treatments in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) or unresectable melanoma.
Patients will receive standard-of-care treatment and will be followed according to routine clinical practice. The study involves the collection of four study-specific blood samples at different time points during follow-up, as well as the collection of standard immunohistochemistry results, thoraco-abdomino-pelvic CT scans, and tumor DNA genotyping analyses performed as part of routine care.
The study aims to determine:
- whether baseline biomarkers in extracellular vesicles are associated with response to anti-PD-1/PD-L1 treatment,
- how these biomarkers change over the course of treatment, and
- to provide exploratory data for the development of predictive immunological response signatures.
Detailed description
Immune checkpoint inhibitors (anti-PD-1/PD-L1) have become standard treatment for patients with advanced or metastatic non-small cell lung cancer (NSCLC) or melanoma. However, not all patients respond to these therapies, and current biomarkers are imperfect.
Circulating extracellular vesicles (EVs) are nanovesicles derived from tumor and immune cells, carrying proteins, nucleic acids, and lipids. They represent an accessible and stable source of immunological biomarkers, allowing monitoring of the tumor microenvironment without additional invasive procedures.
This prospective multicenter study aims to determine, in a prospective cohort of patients with locally advanced or metastatic lung cancer or melanoma, the impact of baseline immune biomarkers present in extracellular vesicles on response to anti-PD-(L)1 therapy
Secondary objectives have also been defined :
- To evaluate the association between longitudinal changes in EV-associated immune biomarkers during follow-up and response to anti-PD-(L)1 therapy.
- To develop a predictive score (immune signature) of response to anti-PD-(L)1 therapy by combining baseline EV-associated immune biomarkers.
- To stratify analyses by tumor type (NSCLC versus melanoma) to determine whether tumor-specific characteristics influence the predictive performance of the identified immune signature.
- To obtain preliminary evidence on the contribution of EV-associated biomarkers to the prediction of primary or secondary resistance to anti-PD-(L)1 therapy.
- In the NSCLC cohort, to compare the predictive performance of the EV-based score with that of a score based solely on the tumor expression (assessed on biopsy specimens) of immunosuppressive proteins, without incorporating EV-associated biomarkers, for predicting best overall response (BOR) at 6 months.
- To explore EV-derived miRNA profiles in responders and non-responders.
- In each cohort, to compare the predictive performance of the EV-based score with that of a score integrating tumor mutational biomarkers derived from ctDNA and/or tumor tissue DNA for predicting BOR at 6 months.
- To evaluate PFS, including PFS at 6 and 12 months, as well as median PFS.
- To establish a prospective plasma biobank from patients treated with anti-PD-(L)1 therapies for future retrospective analyses following completion of the EVpredict study in the field of cancer immunology
Study procedures for participants include:
- Blood sample collection: Four study-specific blood draws performed during standard treatment or tumor assessment visits (baseline, 2nd administration, first evaluation, second evaluation).
- Collection of additional information: Standard immunohistochemistry results thoraco-abdomino-pelvic CT scans; circulating or tumor DNA genotyping analyses.
- Clinical follow-up: Conducted according to routine care standards, with no changes to treatment or additional study-specific visits.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Advanced NSCLC or Melanoma - Anti-PD-(L)1 Therapy | – | –This cohort includes patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) or inoperable melanoma who are receiving standard-of-care anti-PD-1 or anti-PD-L1 therapy, either as monotherapy or in combination with other approved therapies. Participants will follow standard clinical management, and study-specific procedures include four blood draws for extracellular vesicle (EV) analysis at baseline and during follow-up, collection of standard immunohistochemistry results (PD-1, PD-L1, CTLA-4, Tim-3, LAG-3, TIGIT), thoraco-abdominopelvic CT imaging, and tumor DNA genotyping performed as part of routine care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with non-small cell lung cancer (NSCLC) or melanoma, locally advanced or metastatic, and unresectable. For all patients, first-line standard treatment will be based on standard care with an anti-PD-(L)1 therapy, either as monotherapy or in combination (with other immune checkpoint inhibitors or chemotherapy). Standard treatments are defined by the approved indications (marketing authorizations) in France.
Key inclusion criteria (8 listed)
- Age ≥18 years.
- Histologically confirmed diagnosis of non-small cell lung cancer (NSCLC) or locally advanced/metastatic unresectable melanoma.
- Patient scheduled to initiate anti-PD-(L)1 therapy, either as monotherapy or in combination (other immune checkpoint inhibitors, chemotherapy, etc.).
- Baseline tumor assessment performed within 28 days prior to enrollment (CT scan of thorax, abdomen, and pelvis) with at least one measurable lesion according to RECIST 1.1 criteria.
- Life expectancy >6 months.
Key exclusion criteria (10 listed)
- Prior treatment with immunotherapy.
- Presence of EGFR or ALK mutation (applicable only to the lung cohort).
- Presence of another synchronous malignancy.
- Diagnosis of uveal melanoma.
- Treatment with systemic immunosuppressants, including within 28 days prior to enrollment, or corticosteroids >10 mg/day, including within 14 days prior to enrollment.
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
Target protein levels in plasma-derived extracellular vesicles (EVs) measured by multiplex ELISA before treatment
Time frame: 6 months from treatment initiation
Treatment response assessed as Best Overall Response (BOR: complete or partial response per RECIST 1.1) within 6 months.
9 secondary outcomes
Association of EV-Associated Target Protein Concentrations With Best Overall Response at 6 Months
Time frame: Baseline to 6 months after treatment initiation
Development of a Predictive Score Based on Baseline EV-Associated Biomarkers for Best Overall Response at 6 Months
Time frame: Baseline to 6 months after treatment initiation
Predictive Performance of the EV-Based Score for Best Overall Response
Time frame: At 6 months after treatment initiation
EV-Associated Target Protein Concentrations in Non-Responders to Anti-PD-(L)1 Therapy
Time frame: Baseline to 6 months after treatment initiation
Comparison of the Predictive Performance of Tumor Immunohistochemistry and the EV-Based Score in the NSCLC Cohort
Time frame: Baseline to 6 months after treatment initiation
Comparison of EV-Derived miRNA Expression Profiles Between Responders and Non-Responders
Time frame: Baseline to 6 months after treatment initiation
Comparison of the Predictive Performance of Tumor DNA Biomarkers and the EV-Based Score
Time frame: At diagnosis and at disease progression; BOR assessed at 6 months after treatment initiation
Progression-Free Survival (PFS) at 6 and 12 Months and Median PFS
Time frame: From the date of enrollment in the study until the first occurrence of disease progression or death, or up to 12 months after enrollment
Storage of Residual Plasma Samples for Future Retrospective Analyses
Time frame: Up to 15 years after the end of the study
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 26 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Jessica JG GOBBO, Clinical Research Scientist study chair
Centre Georges François Leclerc
5 sites 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 Melanoma (Skin Cancer), run by Centre Georges Francois Leclerc at 5 sites 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 8 inclusion and 10 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 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 Courèche CK KADERBHAI, Doctor (03 80 73 75 28 ext. +33, cgkaderbhai@cgfl.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target protein levels in plasma-derived extracellular vesicles (EVs) measured by multiplex ELISA before treatment (time frame: 6 months from treatment initiation). 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 26 Oct 2026.