Clinical trial · Observational
Immunological Markers Predictive of Response and Toxicity to Checkpoint Inhibitors in Non-small Cell Lung Cancer
Immunological Markers Predictive of Response and Toxicity to Checkpoint in Metastatic Non-Small-cell Lung Cancers
NCT04918836CI-TRIAL-00052172IMMUNO-PREDICTunknownClinicalTrials.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)
A prospective, observational, single-center study to determine the proportion of patients who have or will develop changes in biological markers of immunity during immunotherapy treatment.
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 |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Change of biological markers of immunity under immunotherapy at 6 months
- timeFrame
- Day 0 and month 6 (M6)
- description
- Determine the proportion of patients who have or will develop a change in biological markers of immunity under immunotherapy at 6 months or, failing that, at the end of the immunotherapy (FAN and/or RF and/or anti-tissue and/or decrease in acquired complement verified on the difference between 6 months and inclusion, lymphocyte immunophenotyping)
Secondary outcomes (8)
- measure
- Impact on Overall Survival (OS) and Progression Free Survival (PFS)
- timeFrame
- Day 0 and Six month after (M6)
- description
- Determine if the presence of biological markers of autoimmunity at initiation or during anti-PD1/PDL1 immunotherapy influences overall survival or progression-free survival.
- measure
- Impact on autoimmune toxicity
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Major patient * Metastatic non-small cell lung cancer * Initiation of anti PDL1 therapy (NIVOLUMAB, PEMBROLIZUMAB or ATEZOLIZUAMB) in daily practice * No objection made Exclusion Criteria: * Autoimmune disease diagnosed prior to initiation of immune checkpoint inhibitor therapy. * Previous immune-modulating therapy (including corticosteroid therapy greater than 10 mg/day) * Patient with prior checkpoint inhibitor therapy * Patient with a contraindication to immunotherapy * Patient under legal protection * Refusal to participate
References
Publications (0)
Data not yet available
No reference posted for this study.