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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-A03156-51 | Other Identifier | ID-RCB number,ANSM |
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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.
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| Measure | Description | Time Frame |
|---|---|---|
| The dependent variable will be the cumulative incidence of death or progression under immunotherapy + chemotherapy 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. | At 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Discrimination index (concordance index=C-statistics) of the multiparametric model and model including that of the PD-L1 test. | Compare the discriminant power of the multiparametric model to that of the PD-L1 test alone. | At 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Patients meeting the inclusion criteria will be selected in each of the centers (Lille CHU, Lille Centre Oscar Lambret, Valenciennes Clinique Teissier, Roubaix CH) by the onco-pneumologists and included in the study, after collecting the consent, at the start of treatment with pembrolizumab + chemotherapy in first line.
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| Name | Affiliation | Role |
|---|---|---|
| Sarah Humez | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clcc Oscar Lambret Lille | Lille | 59037 | France | |||
| Hop Calmette Chu Lille |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| Lille |
| 59037 |
| France |
| CH Victor Provot | Roubaix | France |
| Clinique Teissier | Valenciennes | France |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |