Role of Cancer-associated Fibroblast, MDSCs and Immune Cell Interplays in the Resistance of Non-small Cell Lung Cancer to Anti-PD1/PD-L1 Therapies

NCT06024538 | Not Yet Recruiting

• 1 other identifier: CHUBX 2023/34
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Immunotherapy have revolutionized the field of oncology, but response rates are low and all patients relapse, due to cellular and soluble immunosuppressive mechanisms. These immunosuppressive mechanisms will be better characterized and their involvement in therapeutic responses in non-small cell lung cancers (NSCLC). Indeed, large transcriptomic analysis of different subsets of immunosuppressive cells will performed, correlating them to clinical outcome in a cohort of stage III disease, treated by radiochemotherapy and immunotherapy as maintenance, and stage IV treated by immunotherapy as first-line treatment. Furthermore, we will analyse cellular mechanisms by in vitro studies, assessing the effect of immunosuppressive cells, provided by fresh tumor samples, on phenotype and functions of lung cancer cell lines. The aim of this study is to better characterize immunosuppressive landscape of NSCLC and mechanisms involved in their protumor functions.

Conditions

Lung Neoplasm; Cancer Associated Fibroblast; Myeloid-Derived Suppressive Cells Immunosuppression

Keywords

Lung cancer; Immunosuppression; Immunotherapy; Immuno-oncology; Antitumor immune escape

Outcome Measures

Primary Outcomes (1)

• Descriptive analysis of immune infiltration and phenotypic and functional characteristics of the different cell subgroups isolated from fresh tumors

  Exploratory analysis of the immune infiltration (phenotype and function of immunosuppressive and antitumor immune cells) and of the cancer-associated fibroblasts through a transcriptomic analysis of fresh resected lung carcinoma, comparing patients with lymph node involvement or not. Bioinformatics analysis of gene panels

  At the time of surgery only, when fresh tumor is resected

Secondary Outcomes (2)

• Correlation between the infiltration of CAF and immunosuppressive immune cells and with clinicopathological parameters and patient prognosis (relapse free-survival, overall survival) in stage III NSCLC exposed to immunotherapy

  Between September 2018 and December 2021, receiving concomitant radiochemotherapy followed by durvalumab (maintenance)

• Comparative analysis of the modifications of phenotype and functions of MDSC and T lymphocytes when exposed to CAF extracted from patient tumor tissue

  At the time of surgery only, when fresh tumor is resected

Study Arms (1)

Prospective part of the study

Procedure: Tumor samples

Interventions

Tumor samples PROCEDURE

Tumor samples will be collected by the pathologist at the reception of the tumor removed during surgery

Prospective part of the study

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

Patients with lung carcinoma surgically treated by surgery only, or stage III lung carcinoma treated by concomitant radiochemotherapy followed by durvalumab (maintenance) treated between September 2018 and december 2021

You may qualify if:

• consecutive patients
• lung carcinoma surgically treated by surgery only (objectives 1a and 2), or stage III lung carcinoma treated by concomitant radiochemotherapy followed by durvalumab (maintenance) treated between September 2018 and december 2021 (objective 1b)

You may not qualify if:

• patient receiving chemotherapy, radiotherapy or immunotherapy in the neoadjuvant setting (all objectives)
• patient with previous cancer

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

CHU de Bordeaux - Hôpital Saint-André, Service d'Oncologie Médicale

Bordeaux, 33000, France

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Charlotte DOMBLIDES

CONTACT

charlotte.domblides@chu-bordeaux.fr

Matthieu THUMEREL

CONTACT

matthieu.thumerel@chu-bordeaux.fr

Study Design

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

Study Record Dates

• First Submitted: August 28, 2023
• First Posted: September 6, 2023
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)