Non Small Cell Lung CancerEMANCT07470476
Pathophysiological Mechanisms Involved in the Pronostic and Evolution of Non-Small Cell Lung Cancer (NSCLC) at All Stages of the Disease
An observational study of Non Small Cell Lung Cancer, run by University Hospital, Bordeaux.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Translational analyses
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Jun 2041
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patient with Non-Small Cell Lung Cancer (NSCLC) at all stages of the disease
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Translational analyses
- Keywords
- Non small-cell lung cancer, Pathophysiology, Prognosis, Innovative therapies
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Translational analysesBiological
Translational analyses of clinical data and biological samples
| Study group | Role | What they receive |
|---|---|---|
| Localised NSCLC treated by surgery +/- adjuvant therapy | Not described Receives: Biological: Translational analyses | |
| Localised NSCLC treated by neoadjuvant therapy followed by surgery | Not described Receives: Biological: Translational analyses | |
| Locally advanced NSCLC unaccessible to a surgery | Not described Receives: Biological: Translational analyses | |
| Metastatic NSCLC without oncogenic addiction | Not described Receives: Biological: Translational analyses | |
| Metastatic NSCLC with oncogenic addiction | Not described Receives: Biological: Translational analyses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Molecular, metabolic, and immune mechanisms associated with tumor progression and relapse in NSCLC
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.
Measured: From diagnosis until death or study discontinuation, with a maximum follow-up of 10 years
Secondary outcomes (1)
Describe the results obtained in the various preclinical studies conducted in partnership with Inserm and CNRS/UBx teams.
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.
Measured: From diagnosis until death or study discontinuation, with a maximum follow-up of 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study startJun 2026 (estimated)
- Primary completionJun 2036 (estimated)
- Study completionJun 2041 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charlotte DOMBLIDES, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07470476
- Sponsor's protocol ID
- CHUBX 2024/108
- Acronym
- EMA
- Status last verified
- Apr 2026
- First submitted
- 10 Mar 2026
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Progression of NSCLC at All Stages of the Disease - Pathophysiological Mechanisms - Innovative Approaches to Translational Biology
- ClinicalTrials.gov ID
- NCT07470476
- Acronym / sponsor ID
- EMA / CHUBX 2024/108
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- Non small-cell lung cancer, Pathophysiology, Prognosis, Innovative therapies
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jun 2036 (estimated)
- Study completion
- Jun 2041 (estimated)
- First posted
- 13 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Localised NSCLC treated by surgery +/- adjuvant therapy | – | Biological: Translational analyses |
| Localised NSCLC treated by neoadjuvant therapy followed by surgery | – | Biological: Translational analyses |
| Locally advanced NSCLC unaccessible to a surgery | – | Biological: Translational analyses |
| Metastatic NSCLC without oncogenic addiction | – | Biological: Translational analyses |
| Metastatic NSCLC with oncogenic addiction | – | Biological: Translational analyses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patient with Non-Small Cell Lung Cancer (NSCLC) at all stages of the disease
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Translational analysesTranslational analyses of clinical data and biological samples | Biological | Localised NSCLC treated by neoadjuvant therapy followed by surgery, Localised NSCLC treated by surgery +/- adjuvant therapy, Locally advanced NSCLC unaccessible to a surgery, Metastatic NSCLC with oncogenic addiction, Metastatic NSCLC without oncogenic addiction |
Primary outcome
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.
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Charlotte DOMBLIDES principal investigator
University Hospital, Bordeaux
Questions about this trial
What is this clinical trial studying?
An observational study of Non Small Cell Lung Cancer, run by University Hospital, Bordeaux.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charlotte DOMBLIDES (+33556795808, charlotte.domblides@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.