Clinical trial · Observational
Prediction of Response to Treatment With Immunotherapy + Chemotherapy in Non-Small Cell Lung Cancer
NCT04589013CI-TRIAL-00099536PRINCEcompletedClinicalTrials.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)
This study seeks to evaluate a multiparametric test including 6 immunohistochemical markers (PD-L1, CD8, FoxP3, PD1, CD163, CD15) to predict the cumulative incidence of death or progression on treatment with pembrolizumab+first line chemotherapy in metastatic non-small cell lung cancer, regardless of the PD-L1 status and in the absence of ALK, ROS1 or EGFR alteration.
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 (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- The dependent variable will be the cumulative incidence of death or progression under immunotherapy + chemotherapy at 1 year.
- timeFrame
- At 1 year
- description
- Progression will be evaluated by CT imaging every 12 weeks and then every 9 weeks according to RECIST 1.1. The independent variables will be the 6 immunohistochemical markers (PD-L1, CD8, FoxP3, PD1, CD163, CD15) evaluated prior to the first injection of pembrolizumab + chemotherapy from the diagnostic tissue material.
Secondary outcomes (1)
- measure
- Discrimination index (concordance index=C-statistics) of the multiparametric model and model including that of the PD-L1 test.
- timeFrame
- At 1 year
- description
- Compare the discriminant power of the multiparametric model to that of the PD-L1 test alone.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years at time of diagnosis * Affiliation to a social insurance * Obtaining the patient's non opposition * Patients with non-small cell lung carcinoma, confirmed by anatomopathological, metastatic or locally advanced unresectable, not eligible for local curative treatment * Cellular or tissue FFPE available * Indication of treatment with pembrolizumab + first line chemotherapy in multidisciplinary consultation meeting * No mutation of the EGFR gene, no rearrangement of ALK and ROS, * At least one measurable tumor according to RECIST criteria Exclusion Criteria: * Tissue or cellular FFPE not available * Systemic anti-neoplastic or immunotherapy previously received except neoadjuvant or adjuvant treatment completed 6 months or more
References
Publications (0)
Data not yet available
No reference posted for this study.