An interventional study of Metastasis biopsy in Lung Cancer, sponsored by Institut Cancerologie de l'Ouest. Recruiting at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-08.
Sponsored by Institut Cancerologie de l'Ouest · Not applicable, Interventional, and Other
RATIONALE : Currently, the mechanisms associated with the response or resistance to treatment are poorly understood and are multifactorial. These mechanisms involve clinical and biological factors associated with the host and the tumor and possibly the patient's psycho-social environment.
PURPOSE : This trial will assess the use of a prospective database dedicated to patients with breast cancers that contains clinical data as well as epidemiological, psychological, emotional, social, imaging, biological and biopathological data. These data will allow a creation of new modelling algorithms in order to predict response and resistance to treatment.
This prospective study will be conducted on first line metastatic lung cancer patients. Three phenotypic groups are identified on immunohistochemistry done at inclusion: on metastatic sites or lung tumor if local recurrence, usual treatment protocols are often guided by the following groups:
For group 1: SCLC (small cell lung cancer)
For group 2: NSCLC (no small cell lung cancer) without oncogenic addiction:
In case of contra indication of pembrolizumab, treatment will be based on doublet of chemotherapy with platinum salt +/- bevacizumab - Adenocarcinoma, NOS, sarcomatoïde carcinoma or large cell carcinoma with PDL1 expression level \< 50%: Carbo/cisplatin + pemetrexed + pembrolizumab.
In case of contra indication of pembrolizumab, treatment will be based on doublet of chemotherapy with platinum salt +/- bevacizumab
- Squamous cell carcinoma with PDL1 ≥ 50%: Carboplatin + paclitaxel + pembrolizumab or pembrolizumab alone.
In case of contra indication of pembrolizumab, treatment will be based on doublet of chemotherapy with platinum salt - Squamous cell carcinoma with PDL1 \< 50%: Carboplatin + paclitaxel + pembrolizumab or pembrolizumab alone.
In case of contra indication of pembrolizumab, treatment will be based on doublet of chemotherapy with platinum salt
Further treatment lines are administered according to standard practice. Biological and histological assessments are performed on specific metastasis biopsy samples done at baseline and at each progression.
Physical exam, standard laboratory tests, imaging (CT (computerized tomography) scan, PET-CT (Positron emission tomography-computed tomography) and bone scan (for patients with bone metastasis) will be performed every 2 to 3 months according to patient group. Clinical, biological, pathological, epidemiological, socio-economic and multiomic data will be collected throughout the study duration. These massive data will be used to create new algorithms in order to help clinicians to predict treatment response
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's planned enrollment of 200 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Institut Cancerologie de l'Ouest is the lead sponsor of 105 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
At each disease progression, patient will have specific interventions : * Metastasis biopsy * Biomarkers blood, urine and microbiota samples * Patient Reported Outcome (PRO)
Procedure: Metastasis biopsy
Metastasis biopsy will be performed for multi-omic analysis Biological/Vaccine: Biomarkers blood, urine and microbiota samples Biomarkers blood, urine and microbiota samples for multi-omic analysis Behavioral: Patient Reported Outcome (PRO) Patient Reported Outcome (PRO) will be collected throughout the study duration to assess quality of life, anxiety, depression distress, physical activity and food habits.
Overall survival
Overall Survival is defined by the delay between the date of inclusion and the date of death or last follow-up assessment
Time frame: 15 years
To describe response to treatment for each therapeutic sequence
The response to treatment will be assessed using local radiological review according to RECIST 1.1 criteria
Time frame: 15 years
To evaluate progression free survival (PFS) for each therapeutic sequence
Progression Free survival is defined by the delay between the first dose of a treatment sequence and the date of documented disease progression or death
Time frame: 15 years
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Institut Cancerologie de l'Ouest