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

Withdrawn

• Conditions: Non Small Cell Lung Cancer
• Interventions: Other: This is a non-interventional study

• Registration Number: NCT04069442
• Lead Sponsor: University Hospital, Grenoble

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

Study Timeline

• Study First Submitted: 2019-08-12
• Study First Submitted QC: 2019-08-23
• Study First Posted: 2019-08-28
• Study Start: 2020-06
• Primary Completion: 2020-09
• Study Completion: 2020-09
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-26
• Last Update Posted: 2021-04-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
cDC-1 positive	This is a non-interventional study	cDC-1 positive patients according to RNAseq and in situ analysis
cDC-1 negative	This is a non-interventional study	cDC-1 negative patients according to RNAseq and in situ analysis

Primary Outcome Measures

Name	Time	Method
Progression free survival (PFS)	1 year	To validate the cDC1 infiltration as predictive biomarker of pembrolizumab response

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

CHU Grenoble-Alpes; 🇫🇷 Grenoble, Isère, France