Evaluating biomarkers in advanced lung cancer treated with pembrolizumab
Prognostic Value of Combined Approach Based on KEAP1/NFE2L2 Mutations and Pre-therapeutic FDG-PET/CT Radiomic Analysis in Advanced Non-small-cell Lung Cancer PDL1 ≥ 50% Treated With Pembrolizumab.
This study is testing if certain genetic changes and imaging results can help doctors figure out which patients with advanced lung cancer will benefit from a specific immunotherapy treatment called pembrolizumab.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 75 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Brest Academic / other |
| Drugs / interventions | pembrolizumab, immunotherapy, chemotherapy, radiation |
| Locations | 1 site (Brest) |
| Trial ID | NCT05996263 on ClinicalTrials.gov |
What this trial studies
This study investigates the prognostic value of KEAP1/NFE2L2 mutations and pre-therapeutic FDG-PET/CT radiomic analysis in patients with advanced non-small-cell lung cancer (NSCLC) who have a PD-L1 expression of 50% or higher and are treated with pembrolizumab. The aim is to identify biomarkers that can predict which patients are less likely to benefit from this immunotherapy, given that only a fraction of patients respond positively despite having a favorable PD-L1 status. By analyzing genomic alterations and radiomic data, the study seeks to enhance patient selection for treatment and improve outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with histologically or cytologically proven stage III unresectable or stage IV NSCLC and PD-L1 expression of 50% or higher.
Not a fit: Patients with PD-L1 expression below 50%, neuroendocrine tumors, or those who have received previous treatments for NSCLC may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better patient selection for pembrolizumab treatment, potentially improving response rates and outcomes for advanced NSCLC patients.
How similar studies have performed: While the approach of using biomarkers to predict treatment response is established, the specific combination of KEAP1/NFE2L2 mutations and radiomic analysis in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * Histologically or cytologically proven non-small-cell lung cancer (NSCLC) * Stage IV NSCLC. Stage III NSCLC unresectable and not amenable to radiotherapy * PD-L1 expression ≥ 50%. * No previous systemic treatment for NSCLC. * Patients treated for 1st-line metastatic disease with immunotherapy alone (pembrolizumab) * No opposition expressed * Patient affiliated to a social security scheme Exclusion Criteria: * PD-L1 expression \<50 * Neuroendocrine tumors * Secondarily metastatic patients * Previous treatments * Opposition formulated * Patient under legal protection (guardianship, curatorship, etc.)
Where this trial is running
Brest
- Chu Brest — Brest, France (Recruiting)
Study contacts
- Principal investigator: Vincent BOURBONNE, MD, PhD — Radiation Oncology Department, Brest University Hospital
- Study coordinator: Vincent BOURBONNE, MD, PhD
- Email: vincent.bourbonne@chu-brest.fr
- Phone: +33298223398
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.