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

NCT ID: NCT06833229

Last Updated: 2025-04-11

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-27
• Study Completion Date: 2031-01-27

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.

Conditions

Carcinoma, Non-Small-Cell Lung (NSCLC)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

FDG-PET

PET scan are performed within 28 days before the start of immunotherapy, then at week 6 and week 12 of follow-up. Various metabolic parameters extracted from the standard PET image (ΔSUVmax, ΔTLG, appearance of new visceral lesion(s)), parametric (metabolic glucose rate (Ki), volume of distribution (VD)) and tumor response based on PERCIST criteria (adapted to immunotherapy) are assessed.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Antoine Lacassagne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre Antoine Lacassagne

Nice, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Study Coordinator

Role: CONTACT

DRCI-Promotion@nice.unicancer.fr

04 92 03 14 76 ext. +33

Facility Contacts

Olivier HUMBERT

Role: primary

Olivier.HUMBERT@univ-cotedazur.fr

0492031697 ext. +33

Other Identifiers

2021-A00352-39

Identifier Type: OTHER

Identifier Source: secondary_id

2021/11

Identifier Type: -

Identifier Source: org_study_id