Clinico-biological Data Collection Study of Metastatic Lung Cancer

Lung Cancer Clinical Trial

— EPICURE_LUNG  

Official title:

Prediction in Silico of Therapeutic Response in a Prospective Cohort Study of Metastatic Lung Cancer Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04944030
• Other study ID #: ICO-2020-19
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 12, 2023
• Est. completion date: October 2031

Study information

• Verified date: April 2023
• Source: Institut Cancerologie de l'Ouest
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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)

• Carbo or cisplatin + etoposide chemotherapy associated to atezolizumab or durvalumab

• For group 2: NSCLC (no small cell lung cancer) without oncogenic addiction:

• Adenocarcinoma, NOS, sarcomatoïd carcinoma or large cell carcinoma with PDL1 expression level ≥ 50%: Carbo/cisplatin + pemetrexed + pembrolizumab or pembrolizumab alone.

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

• For group 3: NSCLC NSCLC (no small cell lung cancerwith oncogenic addiction (KRAS G12c/BRAFV600E/NTRK/ROS1/ALK/EGFR/RET/NTRK/HER2):

• For which TKI is indicated: TKI as long as possible

• If TKI is not indicated: doublet of chemotherapy with platinum salt +/- pembrolizumab or pembrolizumab alone for PDL1 ≥ 50% or doublet of chemotherapy +/- bevacizumab

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: October 2031
• Est. primary completion date: October 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Written informed consent obtained from the patient prior to performing any protocol-related procedures, including screening biopsy, blood sample, faeces and questionnaires

• 18 years old at time of written consent

• Patient with histologically confirmed lung cancer

• Lung cancer metastatic disease or locally advanced not eligible for local curative treatment intent

• Patient with metastases that can be biopsied.

• Performance status = 2 (according to WHO criteria)

• At least one measurable target on CT scan according to RECIST 1.1

• Indication of any systemic therapeutic strategy can be performed alongside this current cohort in accordance with national and / or international recommendations.

• Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.

• Patient must be affiliated to a Social Health Insurance

Exclusion Criteria:

• Other malignancy treated within the last 3 years (except non-melanoma skin cancer or in situ carcinoma of the cervix)

• Other neuroendocrine tumour than small cell or large cell carcinoma.

• Coagulopathy or other pathology that contraindicates biopsy procedures

• Pregnant or nursing patient

• Individual deprived of liberty or placed under the authority of a tutor

• Impossibility to submit to the medical follow-up of this clinical trial for geographical, social or psychological reasons

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

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.

Locations

Country	Name	City	State
France	Institut de Cancerologie de L'Ouest	Angers
France	Institut de Cancerologie de L'Ouest	St Herblain

Sponsors (1)

Lead Sponsor	Collaborator
Institut Cancerologie de l'Ouest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	Overall Survival is defined by the delay between the date of inclusion and the date of death or last follow-up assessment	15 years
Secondary	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	15 years
Secondary	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	15 years