Evaluating PET scans for predicting treatment response in lung cancer patients
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
This study is testing if PET scans can help predict how well lung cancer patients will respond to immunotherapy, with or without chemotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Antoine Lacassagne Academic / other |
| Drugs / interventions | Nivolumab, pembrolizumab, atezolizumab, durvalumab, avelumab, chemotherapy, immunotherapy |
| Locations | 1 site (Nice) |
| Trial ID | NCT06833229 on ClinicalTrials.gov |
What this trial studies
This observational pilot study aims to assess the effectiveness of 18FDG PET-CT scans in predicting the early response to immunotherapy, with or without chemotherapy, in patients diagnosed with locally advanced or metastatic non-small cell lung carcinoma (NSCLC). The study will analyze specific metabolic biomarkers from the PET scans to determine their ability to identify treatment efficacy compared to current standards. Patients enrolled will be those who have been prescribed immunotherapy and meet specific eligibility criteria.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed metastatic or locally advanced NSCLC who are eligible for immunotherapy.
Not a fit: Patients under 18 years old or those with contraindications to 18FDG PET-CT examinations will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early detection of treatment responses in lung cancer patients, allowing for more personalized and effective treatment plans.
How similar studies have performed: While similar studies have explored the use of PET scans in cancer treatment response, this specific approach focusing on metabolic biomarkers in NSCLC is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Nice
- Centre Antoine Lacassagne — Nice, France (Recruiting)
Study contacts
- Study coordinator: Study Coordinator
- Email: DRCI-Promotion@nice.unicancer.fr
- Phone: 04 92 03 14 76
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.