Pathophysiological Mechanisms Involved in the Pronostic and Evolution of Non-Small Cell Lung Cancer (NSCLC) at All Stages of the Disease (EMA)

April 14, 2026 updated by: University Hospital, Bordeaux

Progression of NSCLC at All Stages of the Disease - Pathophysiological Mechanisms - Innovative Approaches to Translational Biology

This single-center observational cohort study conducted at Bordeaux University Hospital aims to establish a structured clinico-biological platform in non-small cell lung cancer (NSCLC) to investigate the biological mechanisms involved in tumor initiation, progression, and relapse across all disease stages (I-IV).

A total of 150 consecutive adult patients with histologically or cytologically confirmed NSCLC will be included over a 3-year period. Tumor samples will undergo translational analyses. These biological data will be correlated with pseudonymized clinical data collected from medical records and the institutional clinical data warehouse.

The primary objective is to characterize the molecular, metabolic, and immune mechanisms associated with tumor progression and recurrence in NSCLC.

The central hypothesis is that integrating comprehensive clinical data with in-depth molecular and immunological analyses of tumor tissues will identify biologically distinct patterns associated with disease evolution, therapeutic resistance, and prognosis. Such integrated clinico-biological signatures may improve patient stratification and contribute to the identification of novel biomarkers and therapeutic targets in NSCLC.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Lung cancer remains one of the leading causes of cancer-related mortality worldwide. Despite major therapeutic advances over the past two decades, including targeted therapies and immune checkpoint inhibitors, long-term survival remains limited for a substantial proportion of patients. Although five-year survival has improved compared to the early 2000s, prognosis remains heterogeneous and largely dependent on tumor biology, stage at diagnosis, molecular alterations, and host-related factors.

Non-small cell lung cancer (NSCLC) accounts for approximately 85% of lung cancers and represents a biologically heterogeneous group of diseases. Tumor progression and resistance to therapy are driven by complex interactions between tumor cells, the tumor microenvironment, immune components, and host-related factors such as aging, smoking exposure, and chronic inflammatory lung diseases including chronic obstructive pulmonary disease (COPD).

A deeper understanding of these mechanisms is required to:

  • Identify biomarkers associated with tumor progression and relapse
  • Better predict therapeutic response and resistance
  • Develop innovative diagnostic and therapeutic strategies

Bordeaux University Hospital is a regional referral center managing approximately 300-400 lung cancer patients annually. The institution hosts multiple academic research laboratories with expertise in tumor biology, immunology, thoracic diseases, and molecular oncology. This study aims to create a structured translational research continuum integrating clinical care and laboratory research.

Clinical data will be extracted from:

  • The institutional clinical data warehouse
  • Electronic medical records

Data collected will include:

  • Demographics and smoking history
  • Comorbidities (including COPD and other lung diseases)
  • Tumor histology and molecular characteristics
  • TNM staging
  • Treatment modalities (surgery, radiotherapy, systemic therapies)
  • Treatment response and toxicity
  • Recurrence, progression, and survival outcomes Clinical data will be pseudonymized and recorded in a dedicated REDCap electronic case report form hosted at Bordeaux University Hospital.

Clinico-biological correlation analyses will make it possible to define :

  • Response in study patients and evaluation of the impact of the different biological factors on treatment response, assessed according to RECIST 1.1 criteria
  • Prognostic analyses may also be performed on overall survival (time between inclusion and death/loss to follow-up) and progression-free survival (time between inclusion and progression/loss to follow-up/death)
  • Survival of patients in the cohort (overall survival, progression-free survival)
  • Response rate of patients in the cohort according to treatment
  • Factors statistically associated with survival using univariate then multivariate Cox analysis
  • Treatment tolerance (descriptive analysis)
  • List of pathways involved in resistance processes, and description of newly identified therapeutic targets for the different treatments
  • Validation of the functional involvement of proteins/pathways in in vitro models

Biological Samples and Translational Analyses Tumor samples consist of formalin-fixed paraffin-embedded (FFPE) biopsy or surgical specimens stored at the institutional Biological Resource Center.

Samples will undergo translational analyses in partner academic laboratories, including:

  • Molecular characterization of tumor cells
  • Metabolic profiling
  • Characterization of the tumor immune microenvironment
  • Evaluation of immunosuppressive pathways
  • Analysis of secretome-related functions
  • Identification of aging-related biological signatures

After analysis, biological data will be securely transferred to the coordinating center and correlated with clinical variables.

All samples and associated data will be pseudonymized in accordance with applicable data protection regulations.

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patient with Non-Small Cell Lung Cancer (NSCLC) at all stages of the disease

Description

Inclusion Criteria:

  • Adult patients
  • NSCLC treated at the Bordeaux University Hospital.
  • TNM stage between I to IV
  • Patient affiliated with or beneficiary of a social security scheme.
  • Non opposition

Exclusion Criteria:

  • Patients with small cell lung cancer.
  • History of any other malignancy other than NSCLC within 1 years prior to screening. except for non-melanoma skin cancers, in situ cancers, or low-risk prostate cancer
  • Pregnant or breastfeeding women.
  • Patients with a medical or psychiatric condition or illness that compromises their ability to understand the information or participate in the study.
  • Individuals subject to legal protection measures (legal guardianship, trusteeship or curatorship).
  • Individuals deprived of their liberty by judicial or administrative decision.
  • Individuals who are unable to give their consent.
  • Patients who are in a period of exclusion following another study or who have participated in another interventional study involving a medicinal product within 30 days prior to entry into the protocol or who are participating in another clinical study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Localised NSCLC treated by surgery +/- adjuvant therapy
Biological: Translational analyses
Translational analyses of clinical data and biological samples
Localised NSCLC treated by neoadjuvant therapy followed by surgery
Biological: Translational analyses
Translational analyses of clinical data and biological samples
Locally advanced NSCLC unaccessible to a surgery
Biological: Translational analyses
Translational analyses of clinical data and biological samples
Metastatic NSCLC without oncogenic addiction
Biological: Translational analyses
Translational analyses of clinical data and biological samples
Metastatic NSCLC with oncogenic addiction
Biological: Translational analyses
Translational analyses of clinical data and biological samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Molecular, metabolic, and immune mechanisms associated with tumor progression and relapse in NSCLC
Time Frame: From diagnosis until death or study discontinuation, with a maximum follow-up of 10 years
Comprehensive characterization of molecular alterations, metabolic profiles, and immune microenvironment features identified in tumor tissue samples (FFPE specimens), and their association with clinical indicators of disease progression or recurrence. Analyses will include correlation between biological signatures and progression-free survival, relapse occurrence, and overall survival across predefined disease stage cohorts.
From diagnosis until death or study discontinuation, with a maximum follow-up of 10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Describe the results obtained in the various preclinical studies conducted in partnership with Inserm and CNRS/UBx teams.
Time Frame: From diagnosis until death or study discontinuation, with a maximum follow-up of 10 years
Identification of biological links between precancerous conditions, including Chronic Obstructive Pulmonary Disease (COPD) and bronchial remodeling, and the development of non-small cell lung cancer; Characterization of the immunosuppressive tumor microenvironment in non-small cell lung cancer and its impact on prognosis and treatment response; Identification of aging-related biomarkers in elderly patients with non-small cell lung cancer to optimize and personalize treatment strategies; Investigation of the specific functions of the secretome in non-small cell lung cancer.
From diagnosis until death or study discontinuation, with a maximum follow-up of 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Investigators

  • Principal Investigator: Charlotte DOMBLIDES, University Hospital, Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2036

Study Completion (Estimated)

June 1, 2041

Study Registration Dates

First Submitted

March 10, 2026

First Submitted That Met QC Criteria

March 10, 2026

First Posted (Actual)

March 13, 2026

Study Record Updates

Last Update Posted (Actual)

April 17, 2026

Last Update Submitted That Met QC Criteria

April 14, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2024/108

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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