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

NCT04069442 | Withdrawn

• 2 other identifiers: 38RC19.1002019-A00959-48
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS)

  To validate the cDC1 infiltration as predictive biomarker of pembrolizumab response

  1 year

Secondary Outcomes (2)

• Overall response rate (ORR)

  1 year

• Time to treatment failure (TTF)

  1 year

Other Outcomes (1)

• Overall survival (OS)

  1 year

Study Arms (2)

cDC-1 positive

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

Other: 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

Interventions

This is a non-interventional study OTHER

This is a non-interventional study

cDC-1 negative; cDC-1 positive

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

CHU Grenoble-Alpes

Grenoble, Isère, 38043, France

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Elisa GOBBINI

  CHU Grenoble Alpes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2019
• First Posted: August 28, 2019
• Study Start: June 1, 2020
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: April 1, 2021

Record last verified: 2021-03

Locations

FR (1)