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

• Sponsor: University Hospital, Grenoble (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT04069442
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Anticipated Duration (Months): 3
• Patients Per Site Per Month: 0

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non Small Cell Lung Cancer	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 Design

• Study Type: Observational
• Actual Enrollment: 0 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: cDC1 Prognostic and Predictive Role in Non-Small-Cell Lung Cancer Patients Receiving Immune Checkpoint Inhibitors
• Anticipated Study Start Date: Jun 1, 2020
• Anticipated Primary Completion Date: Sep 1, 2020
• Anticipated Study Completion Date: Sep 1, 2020

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Progression free survival (PFS) [1 year]

   To validate the cDC1 infiltration as predictive biomarker of pembrolizumab response

Secondary Outcome Measures

1. 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

2. 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 Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Grenoble-Alpes	Grenoble	Isère	France	38043

Sponsors and Collaborators

• University Hospital, Grenoble

Investigators

• Principal Investigator: Elisa GOBBINI, CHU Grenoble Alpes

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Grenoble
• ClinicalTrials.gov Identifier: NCT04069442
• Other Study ID Numbers: 38RC19.100; 2019-A00959-48
• First Posted: Aug 28, 2019
• Last Update Posted: Apr 1, 2021
• Last Verified: Mar 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of Apr 1, 2021