Non Small Cell Lung Cancer
Conditions
Brief summary
The response rate of immune checkpoint inhibitors remains relatively low and the identification of the new predictive biomarkers is necessary. The rare population of cDC1 is very interesting, as its mouse counterparts is essential for the cross presentation of tumor-associated antigens, tumor immunity and response to immunotherapies. Their role in humans has not been studied. This proposal aims to study the prognostic role of cDC1 in a cohort of patients with advanced NSCLC, possibly demonstrating their positive predictive value of immune checkpoint inhibitors response.
Detailed description
Multicenter study aiming to collect patient's clinical data retrospectively and their histological samples prospectively. The cohort will include: * 30 patients PD-L1 \> 50% treated with pembrolizumab in first line and having a progression free survival ≥ 3 months * 30 patients PD-L1 \> 50% treated with pembrolizumab in first line and having a progression free survival \< 3 months * 30 patients PD-L1 \< 50% treated with cisplatin-based chemotherapy in first line
Interventions
This is a non-interventional study
Sponsors
Study design
Eligibility
Inclusion criteria
* NSCLC diagnosis * Advanced disease (Stage III-IV) according to the TNM 7th/8th classification * Patients have to have performed pembrolizumab in first line if PD-L1 ≥ 50% or cisplastin-based chemotherapy if PD-L1 \< 50% * FFPE material available from diagnostic sample
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival (PFS) | 1 year | To validate the cDC1 infiltration as predictive biomarker of pembrolizumab response |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate (ORR) | 1 year | To compare the overall response rate (ORR) of cDC1-positive patients to cDC1 negative ones within those treated with pembrolizumab and on the entire cohort |
| Time to treatment failure (TTF) | 1 year | To compare the time of treatment failure (TTF) on CDC1-positive patients to negatives ones within those treated with pembrolizumaband on the entire cohort |
Other
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | 1 year | To compare the overall survival (OS) of cDC1-positives patients to negatives ones within those treated with pembrolozumab and on the entire cohort |
Countries
France