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

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.

Study Overview

• Status: Withdrawn
• Conditions: Non Small Cell Lung Cancer
• Intervention / Treatment: Other: This is a non-interventional study

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 Type: Observational

Contacts and Locations

Study Locations

• France
  • Isère
    • Grenoble, Isère, France, 38043
      • CHU Grenoble-Alpes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Retrospective cohort of pembrolizumab or cisplatin-based chemiotherapy treated patients performing these regimens in first-line according to their PD-L1 score

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
cDC-1 positive; cDC-1 positive patients according to RNAseq and in situ analysis	Other: This is a non-interventional study; This is a non-interventional study
cDC-1 negative; cDC-1 negative patients according to RNAseq and in situ analysis	Other: This is a non-interventional study; This is a non-interventional study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression free survival (PFS)	To validate the cDC1 infiltration as predictive biomarker of pembrolizumab response	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall response rate (ORR)	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	1 year
Time to treatment failure (TTF)	To compare the time of treatment failure (TTF) on CDC1-positive patients to negatives ones within those treated with pembrolizumaband on the entire cohort	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival (OS)	To compare the overall survival (OS) of cDC1-positives patients to negatives ones within those treated with pembrolozumab and on the entire cohort	1 year

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Investigators: Principal Investigator: Elisa GOBBINI, CHU Grenoble Alpes

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2020
• Primary Completion (Anticipated): September 1, 2020
• Study Completion (Anticipated): September 1, 2020

Study Registration Dates

• First Submitted: August 12, 2019
• First Submitted That Met QC Criteria: August 23, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Actual): April 1, 2021
• Last Update Submitted That Met QC Criteria: March 26, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: 38RC19.100; 2019-A00959-48 (Other Identifier: ID RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No