cDC1 Prognostic and Predictive Role in Non-Small-Cell Lung Cancer Patients Receiving Immune Checkpoint Inhibitors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-30

Study Completion Date

2020-09-30

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Non Small Cell Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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cDC-1 positive

cDC-1 positive patients according to RNAseq and in situ analysis

This is a non-interventional study

Intervention Type OTHER

This is a non-interventional study

cDC-1 negative

cDC-1 negative patients according to RNAseq and in situ analysis

This is a non-interventional study

Intervention Type OTHER

This is a non-interventional study

Interventions

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This is a non-interventional study

Intervention Type OTHER

Eligibility Criteria

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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