Clinical trial · Observational
Identification of a Predictive Metabolic Signature of Response to Immune Checkpoint Inhibitors in Non-Small Cell Lung Carcinoma
: Identification of a Predictive Metabolic Signature of Response to Immune Checkpoint Inhibitors in Non-Small Cell Lung Carcinoma
NCT04189679CI-TRIAL-00073041METABO-ICIcompletedClinicalTrials.gov clinicaltrialsProvenance
- 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)
Immune checkpoints inhibitors (ICI) are becoming new standards of care for Non-Small Cell Lung Carcinoma (NSCLC) treatment. To date, no powerful predictive biomarker of response has been found. The investigators hypothesize that metabolomics profile could represent a potent biomarker of response to ICI
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Immune signature in serum associated to the metabolic signature | Other | — | UNRESOLVED |
| Meta-genomic signature of intestinal flora | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- First line
- description
- 20 patients in first line of treatment
- interventionNames
- Other: Immune signature in serum associated to the metabolic signature
- Genetic: Meta-genomic signature of intestinal flora
- label
- Second or third line
- description
- 40 patients in second and third line of treatment
- interventionNames
- Other: Immune signature in serum associated to the metabolic signature
- Genetic: Meta-genomic signature of intestinal flora
Primary outcomes (1)
- measure
- Identification of the change from baseline Metabolic signature as predictive factor of the ICI response at 6 months or at the tumoral progression
- timeFrame
- baseline, 6 months or tumoral progression
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * NSCLC diagnosis * Patient treated by a ICI in first, second or third line of treatment, or by the combination of chemotherapy and IPCI in first line of treatment * Patient with at least one measurable lesion as defined by RECIST Exclusion Criteria: * Patient treated with antibiotic treatment within 2 weeks before the start of ICI or corticosteroids (\>20 mg per day) within 4 weeks before the start of ICI
References
Publications (0)
Data not yet available
No reference posted for this study.