Clinical trial · Observational
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 (PEMBROMIC)
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Pembrolizumab has been approved for first-line locally advanced or metastatic NSCLC with a tumor proportion score (TPS) ≥50% for PDL1, based on the results of KEYNOTE-024. However, even with a positive PDL1 status, only a fraction of patients respond to immunotherapy. In the KEYNOTE-024 study evaluating pembrolizumab versus chemotherapy in first-line advanced NSCLC with PDL1 TPS ≥50%, the response rate in the pembrolizumab arm alone was 45%. NFE2L2 is a transcription factor that directs the expression of free radical defense genes that may interfere with radiation-induced DNA damage. KEAP1 is an adaptor protein that targets NFE2L2 for ubiquitination and proteasomal destruction as part of normal homeostasis. These new biomarkers are of clinical interest, as KEAP1/NFE2L2 mutations predict radiation resistance in patients with localized NSCLC treated with radiotherapy but not surgery. Some data also suggest a role for the KEAP1/NFE2L2 axis in response to immunotherapy. Establishing a predictive model for the presence of the KEAP1/NFE2L2 mutation would provide a tool for predicting survival (progression-free and overall), even before the patient starts immunotherapy.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer Stage III | Malignant Lung Neoplasm | CURATED_BROADER | 0.78 |
| Lung Cancer Stage IV | Malignant Lung Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Progression-Free survival (PFS)
- timeFrame
- through study completion, an average of 1 year
- description
- PFS is defined as the time elapsed between initiation of treatment and tumor progression or death from any cause.
Secondary outcomes (1)
- measure
- Overall Survival (OS)
- timeFrame
- through study completion, an average of 1 year
- description
- OS is defined as the time elapsed between initiation of treatment and death, whatever the cause.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.)
References
Publications (0)
Data not yet available