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)

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: Recruiting
• Conditions: Carcinoma, Non-Small-Cell Lung (NSCLC)
• Intervention / Treatment: Procedure: FDG-PET

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Study Coordinator; Phone Number: +33 04 92 03 14 76; Email: DRCI-Promotion@nice.unicancer.fr

Study Locations

• France
  • Nice, France, 06189
    • Recruiting
    • Centre Antoine Lacassagne
    • Contact: Olivier HUMBERT; Phone Number: +33 0492031697; Email: Olivier.HUMBERT@univ-cotedazur.fr

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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)	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

Outcome Measure	Measure Description	Time Frame
Incidence of pseudo-progressions versus true tumor progressions at the first PET scan at 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	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.	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.	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

• Sponsor: Centre Antoine Lacassagne

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2022
• Primary Completion (Estimated): May 27, 2028
• Study Completion (Estimated): January 27, 2031

Study Registration Dates

• First Submitted: February 13, 2025
• First Submitted That Met QC Criteria: February 13, 2025
• First Posted (Actual): February 18, 2025

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Neoplasms by Histologic Type; Lung Diseases; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma; Carcinoma, Non-Small-Cell Lung
• Other Study ID 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