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Clinico-biological Data Collection Study of Metastatic Lung Cancer (EPICURE_LUNG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04944030
Recruitment Status : Not yet recruiting
First Posted : June 29, 2021
Last Update Posted : July 27, 2022
Sponsor:
Information provided by (Responsible Party):
Institut Cancerologie de l'Ouest

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.


Condition or disease Intervention/treatment Phase
Lung Cancer Procedure: Metastasis biopsy Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Prediction in Silico of Therapeutic Response in a Prospective Cohort Study of Metastatic Lung Cancer Patients
Estimated Study Start Date : October 2022
Estimated Primary Completion Date : October 2031
Estimated Study Completion Date : October 2031

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy Lung Cancer

Arm Intervention/treatment
Experimental: SCLC (small cell lung cancer)

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.

Experimental: NSCLC (no small cell lung lung cancer) without oncogenic addiction:

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.

Experimental: NSCLC (no small cell lung lung cancer) with oncogenic addiction

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.




Primary Outcome Measures :
  1. Overall survival [ Time Frame: 15 years ]
    Overall Survival is defined by the delay between the date of inclusion and the date of death or last follow-up assessment


Secondary Outcome Measures :
  1. To describe response to treatment for each therapeutic sequence [ Time Frame: 15 years ]
    The response to treatment will be assessed using local radiological review according to RECIST 1.1 criteria

  2. To evaluate progression free survival (PFS) for each therapeutic sequence [ Time Frame: 15 years ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04944030


Contacts
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Contact: JUDITH RAIMBOURG, MD,PHD 0240679900 ext +33 judith.raimbourg@ico.unicancer.fr
Contact: MARINE TIGREAT 0240679878 ext +33 marine.tigreat@ico.unicancer.fr

Locations
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France
Institut de Cancerologie de L'Ouest
Angers, France, 49933
Contact: FREDERIC BIGOT, MD       frederic.bigot@ico.unicancer.fr   
Institut de Cancerologie de L'Ouest
St Herblain, France, 44805
Contact: JUDITH RAIMBOURG, MD, PHD       judith.raimbourg@ico.unicancer.fr   
Sponsors and Collaborators
Institut Cancerologie de l'Ouest
Investigators
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Principal Investigator: JUDITH RAIMBOURG, MD,PHD judith.raimbourg@ico.unicancer.fr
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Responsible Party: Institut Cancerologie de l'Ouest
ClinicalTrials.gov Identifier: NCT04944030    
Other Study ID Numbers: ICO-2020-19
First Posted: June 29, 2021    Key Record Dates
Last Update Posted: July 27, 2022
Last Verified: July 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut Cancerologie de l'Ouest:
Lung cancer
Prospective clinico-biological database
Multi omic analysis
Prediction in silico
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases