Clinico-biological Data Collection Study of Metastatic Lung Cancer

NCT ID: NCT04944030

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-24
• Study Completion Date: 2031-10-31

Brief 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.

Detailed 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

Conditions

Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Follow

At each disease progression, patient will have specific interventions :

• Metastasis biopsy
• Biomarkers blood, urine and microbiota samples
• Patient Reported Outcome (PRO)

Group Type: OTHER

Metastasis biopsy

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Written informed consent obtained from the patient prior to performing any protocol-related procedures, including screening biopsy, blood sample 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
• Performance status ≤ 2 (according to WHO criteria)
• 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.
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Cancerologie de l'Ouest

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

JUDITH RAIMBOURG, MD,PHD

Role: PRINCIPAL_INVESTIGATOR

judith.raimbourg@ico.unicancer.fr

Locations

Institut de Cancerologie de L'Ouest

Angers, , France

Site Status: RECRUITING

Institut de Cancerologie de L'Ouest

Saint-Herblain, , France

Site Status: RECRUITING

Countries

France

Central Contacts

JUDITH RAIMBOURG, MD,PHD

Role: CONTACT

judith.raimbourg@ico.unicancer.fr

0240679900 ext. +33

MARINE TIGREAT

Role: CONTACT

marine.tigreat@ico.unicancer.fr

0240679878 ext. +33

Facility Contacts

FREDERIC BIGOT, MD

Role: primary

frederic.bigot@ico.unicancer.fr

JUDITH RAIMBOURG, MD, PHD

Role: primary

judith.raimbourg@ico.unicancer.fr

Other Identifiers

ICO-2020-19

Identifier Type: -

Identifier Source: org_study_id