Prediction of Response to Treatment With Immunotherapy + Chemotherapy in Non-Small Cell Lung Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Non-small Cell Lung Cancer
- Sponsor
- University Hospital, Lille
- Enrollment
- 106
- Locations
- 4
- Primary Endpoint
- The dependent variable will be the cumulative incidence of death or progression under immunotherapy + chemotherapy at 1 year.
- Status
- Completed
- Last Updated
- 4 months ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
The dependent variable will be the cumulative incidence of death or progression under immunotherapy + chemotherapy at 1 year.
Time Frame: At 1 year
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
- Discrimination index (concordance index=C-statistics) of the multiparametric model and model including that of the PD-L1 test.(At 1 year)