Clinical trial NCT06833229: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Carcinoma, Non-Small-Cell Lung (NSCLC)
Lead sponsor: Centre Antoine Lacassagne
Sponsor class: OTHER
First posted: 2025-02-18
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Metabolic criteria for PET imaging that can distinguish true tumor progression from pseudo-progression of inflammatory origin (leukocyte infiltrate)
timeFrame: 36 months
Secondary outcomes:
measure: Incidence of pseudo-progressions versus true tumor progressions at the first PET scan at 6 weeks.
timeFrame: 6 weeks
measure: Prognostic value of metabolic response PET-CT at 6 weeks and 12 weeks on overall survival at 12, 24 and 36 months
timeFrame: 36 months
measure: Use of supervised deep-learning algorithms (neural networks) to classify patients as immunotherapy responders or non-responders.
timeFrame: 6 months
measure: Evaluation of overall survival of patients with oligometastatic progression with maintenance of immunotherapy and targeted irradiation of progressing lesions.
timeFrame: 36 months
Other outcomes:
Locations:
city: Nice
country: France
facility: Centre Antoine Lacassagne
Study officials:
References: