Prospective Cohort Study Evaluating 18FDG PET-CT for the Early Prediction of the Efficacy of Immunotherapy Associated or Not With Chemotherapy in Patients With Locally Advanced or Metastatic Non-Small Cell Broncho-Pulmonary Carcinoma (FDG Immun Comb)

May 27, 2026 updated by: Centre Antoine Lacassagne
The hypothesis of this prospective observational pilot study of diagnostic diagnostic performance is that, for patients with NSCLC treated with immunotherapy associated or not with chemotherapy, certain metabolic biomarkers on 18FDG PET scans allow early identification of treatment response (or lack of response to treatment) and optimize prediction of tumor response compared with current standards.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients with locally advanced or metastatic NSCLC with an indication for immunotherapy combined with concomitant chemotherapy as standard treatment and managed at the Centre Antoine Lacassagne will be eligible.

Description

Inclusion Criteria:

  • Age greater than or equal to 18 years,
  • Patients with histologically proven, metastatic or locally advanced NSCLC, with indication for immunotherapy (Nivolumab, pembrolizumab, atezolizumab, durvalumab, avelumab), in combination or not with chemotherapy molecules (carboplatin, cisplatin, pemetrexed, paclitaxel or nab-paclitaxel), validated by a Multidisciplinary Team and prescribed within the scope of their Marketed Authorization, whatever the line of treatment treatment line,
  • ECOG 0 to 3,
  • The patient's understanding of the protocol and the note of non-opposition, with oral agreement,
  • Patient has not objected to the use of his or her data for medical research. research,
  • Patient has social security coverage.

Exclusion Criteria:

  • Age under 18,
  • Contraindication to 18FDG PET-CT examinations: severe claustrophobia, unbalanced diabetes at the time of the first PET-CT scan (fasting capillary glucose ≥ 11 mmol),
  • Hemoglobin less than 7 g/dL at inclusion. If the patient has a respiratory or or cardiovascular pathology, hemoglobin must not be less than 9.0 g/dL,
  • Any participation in other biomedical studies involving the drug, medical devices or medical devices or imaging techniques is prohibited, with the exception of biomedical studies,
  • Refusal to participate in the present study,
  • Contraindication (e.g. hypersensitivity to the active substance or to one of the excipients of immunotherapy or chemotherapy treatments...).

  • Vulnerable persons are defined in article L1121-5 to -8:

    • Pregnant women, parturients and nursing mothers, persons deprived of their liberty by judicial or administrative decision, persons hospitalized without consent under articles L. 3212-1 and L. 3213-1 who are not covered by the provisions of the provisions of article L. 1121-8,
    • and persons admitted to a health or social establishment for purposes other than research purposes,
    • adults who are the subject of a legal protection measure, or who are unable to exercise their non opposition

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Metabolic criteria for PET imaging that can distinguish true tumor progression from pseudo-progression of inflammatory origin (leukocyte infiltrate)
Time Frame: 36 months
Calculation of the area of the ROC curve and determination of the optimal threshold of different metabolic parameters extracted from the standard PET image (ΔSUVmax, ΔTLG, appearance of new visceral lesion(s)) and parametric PET image (metabolic glucose rate (Ki), volume of distribution (VD)) to distinguish lesions between true progression from inflammatory pseudoprogressions.
36 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of pseudo-progressions versus true tumor progressions at the first PET scan at 6 weeks.
Time Frame: 6 weeks
Evaluation of the ratio between lesions with pseudo-inflammatory progression and those with true tumor progression (defined a posteriori on control PET-CT). A analysis per lesion and per patient. Two groups of patients will be compared: the group treated with immunotherapy alone and the group treated with a combination of immunotherapy and chemotherapy
6 weeks
Prognostic value of metabolic response PET-CT at 6 weeks and 12 weeks on overall survival at 12, 24 and 36 months
Time Frame: 36 months
Overall survival at 12, 24 and 36 months as a function of changes in tumor metabolism on the first interim PET-CT scans (PERCIST and ΔSUV analysis). Overall survival: time from date of inclusion to date of death from any cause.
36 months
Evaluation of overall survival of patients with oligometastatic progression with maintenance of immunotherapy and targeted irradiation of progressing lesions.
Time Frame: 36 months
Overall survival at 24 months as a function of whether or not irradiation (as part of standard practices) of progressing lesions in patients with metastatic oligo-progression on 18FDG PET (between 1 and 3 progressive lesions).
36 months
Use of supervised deep-learning algorithms (neural networks) to classify patients as immunotherapy responders or non-responders.
Time Frame: 6 months
Non-responders will be defined as patients who discontinue immunotherapy within the first 6 months of treatment due to tumor progression. Responders will be defined by continuation of immunotherapy beyond 6 months of treatment.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Antoine Lacassagne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 27, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 27, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 27, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 13, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 18, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2021/11
  • 2021-A00352-39 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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