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

Non Small Cell Lung Cancer Clinical Trial

— LUNG-PREDICT  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04069442
• Other study ID #: 38RC19.100
• Secondary ID: 2019-A00959-48
• Status: Withdrawn
• Start date: June 2020
• Est. completion date: September 2020

Study information

• Verified date: March 2021
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

-

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Other:
• This is a non-interventional study
This is a non-interventional study

Locations

Country	Name	City	State
France	CHU Grenoble-Alpes	Grenoble	Isère

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	Progression free survival (PFS)	To validate the cDC1 infiltration as predictive biomarker of pembrolizumab response	1 year
Secondary	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
Secondary	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