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Blood test may predict immunotherapy success in cancer patients

NCT ID NCT07376512

Knowledge-focused Sponsor: Centre Georges Francois Leclerc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether tiny particles in the blood, called extracellular vesicles, can help doctors predict if immunotherapy will work for people with advanced lung cancer or melanoma. Researchers will collect blood samples from 378 patients before and during standard treatment. The goal is to find biomarkers that show who is likely to respond well, helping personalize cancer care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 378 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Mar 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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).

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Conditions

The condition(s) this trial relates to.

melanoma non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Melanoma (skin cancer) Non-small cell lung cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CHU Besançon - Service Dermatologie

    Besançon, 25000, France

  • CHU Besançon - Service Pneumologie Oncologie Thoracique

    Besançon, 25000, France

  • CHU Dijon - Service Oncologie Médicale

    Dijon, 21000, France

  • Centre Georges-François Leclerc

    Dijon, 21000, France

  • Centre Leon Berard - Service Oncologie Médicale

    Lyon, 69000, France

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