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LIquid Biopsy to prEdict Responses To First-line immunotherapY in Metastatic Non-small Cell LUNG Cancer. LIBERTY LUNG (LIBERTYLUNG)

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ClinicalTrials.gov Identifier: NCT04790682
Recruitment Status : Not yet recruiting
First Posted : March 10, 2021
Last Update Posted : March 12, 2021
Sponsor:
Information provided by (Responsible Party):
Institut Curie

Brief Summary:
Patient with histologically proven NSCLC in a metastatic stage, treatment naïve and eligible for first-line treatment with immune checkpoint inhibitor. Combination with chemotherapy is possible. Presence of a mutation after NGS analysis is required for ctDNA follow-up.

Condition or disease Intervention/treatment Phase
NSCLC Patient in a Metastatic Stage Eligible for First-line Treatment With Immune Checkpoint Inhibitor Biological: assessment of the predictive value of ctDNA level of the prominent mutant allele variation between baseline and week 6, on response to treatment according to RECIST 1.1 criteria. Not Applicable

Detailed Description:

A pre-screening consent will be obtained for NGS analysis on tumor tissue. Only patients with at least 1 mutation at NGS on the tumor tissue will ultimately be enrolled in the study, to have the possibility to follow the mutation using ctDNA. Main consent will be obtained after results of the NGS and before initiation of pembrolizumab. Computed Tomography (CT)-scan imaging will be done every 9 weeks as part of routine care practice. Blood specimens will be taken with EDTA tubes or streck tubes at the time of puncture for pembrolizumab infusion at baseline before starting treatment, at 3 weeks, 6 weeks and then every 6 weeks. Blood immunomonitoring will be done before starting the treatment, at 6 weeks and at 18 week. An additional measurement will be performed if treatment is stopped before the end of the study.

- Optional blood samples will be realized to analyse the degree of activity of the plasmatic lymphocytes.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: LIquid Biopsy to prEdict Responses To First-line immunotherapY in Metastatic Non-small Cell LUNG Cancer
Estimated Study Start Date : April 1, 2021
Estimated Primary Completion Date : July 1, 2022
Estimated Study Completion Date : April 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
Experimental: NSCLC patient in a metastatic stage eligible for 1st-line TT with immune checkpoint inhibitor. Biological: assessment of the predictive value of ctDNA level of the prominent mutant allele variation between baseline and week 6, on response to treatment according to RECIST 1.1 criteria.
  • At pre-screening NGS analysis on tumor tissue (slides). Only patients with at least 1 mutation at NGS on the tumor tissue will ultimately be enrolled in the main study, to have the possibility to follow the mutation using ctDNA.
  • Main study will be initiated after results of the NGS and before initiation of pembrolizumab. Blood specimens will be taken with EDTA tubes or streck tubes at the time of puncture for pembrolizumab infusion at baseline before starting treatment, at 3 weeks, 6 weeks and then every 6 weeks (30 ml at Baseline then 20 ml of blood). Blood immunomonitoring will be done before starting the treatment, at 6 weeks and at 18 Week. An additional measurement will be performed if treatment is stopped before the end of the study (18 ml of blood).
  • Optional blood samples will be realized to analyse the degree of activity of the plasmatic lymphocytes before starting the treatment and at 6 weeks and (18 ml of blood).




Primary Outcome Measures :
  1. ctDNA variation of the prominent mutant allele variation [ Time Frame: 6 weeks on response to treatment defined as the proportion of patients who will achieve a complete or partial response at CT-scan based on RECIST 1.1 criteria ]
    ctDNA variation of the prominent mutant allele variation between baseline and week 6, on response to treatment defined as the proportion of patients who will achieve a complete or partial response at CT-scan based on RECIST 1.1 criteria.


Secondary Outcome Measures :
  1. ctDNA variation of the prominent mutant allele variation [ Time Frame: 6 weeks on response to treatment defined as the proportion of patients who will achieve a complete or partial response at CT-scan based on iRECIST criteria. ]
    ctDNA variation of the prominent mutant allele variation between baseline and week 6, on response to treatment defined as the proportion of patients who will achieve a complete or partial response at CT-scan based on iRECIST criteria.

  2. Progression-free survival [ Time Frame: 6 weeks after progression after first-line treatment or a maximum of 21 months ]
    Progression-free survival according to immune cell levels in the blood

  3. Overall survival [ Time Frame: 6 weeks after progression after first-line treatment or a maximum of 21 months ]
    Overall survival according to immune cell levels in the blood

  4. Progression-free survival [ Time Frame: 6 weeks after progression after first-line treatment or a maximum of 21 months ]
    Progression-free survival according to immune cell levels variations in the blood

  5. Overall survival [ Time Frame: 6 weeks after progression after first-line treatment or a maximum of 21 months ]
    Overall survival according to immune cell levels variations in the blood

  6. Progression-free [ Time Frame: 6 weeks after progression after first-line treatment or a maximum of 21 months ]
    Progression-free survival according to ctDNA level variations.

  7. Overall survival [ Time Frame: 6 weeks after progression after first-line treatment or a maximum of 21 months ]
    Overall survival according to ctDNA level variations.

  8. Response rate to the second line of treatment [ Time Frame: 6 weeks after progression after first-line treatment or a maximum of 21 months ]
    Response rate to the second line of treatment based on RECIST 1.1 and iRECIST criteria according to ctDNA level at week 6 of the second line of treatment.

  9. Adverse events of special interest [ Time Frame: 6 weeks after progression after first-line treatment or a maximum of 21 months ]
    Adverse events of special interest of grade 3 or more (CTCAE v5.0).



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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:

  1. Histologically-proven NSCLC.
  2. Age ≥ 18 years.
  3. Advanced or metastatic stage IV.
  4. Treatment-naïve patient.
  5. Eligibility to first-line treatment with immune checkpoint inhibitor.
  6. Measurable disease according to RECIST 1.1 criteria on CT-Scan.
  7. Availability of expression of PD-L1 at immunohistochemistry analysis of the tumor biopsy.
  8. No ALK or EGFR gene alteration.
  9. Availability of tumor tissue for NGS analysis (7 slides).
  10. PS 0 or 1.
  11. Signed informed consent of the patient.

Exclusion Criteria:

  1. No social security affiliation.
  2. Person under legal protection.
  3. Pregnant and breastfeeding women.

Patients can participate to another clinical trial that is not modifying immunotherapy or immunotherapy/chemotherapy treatment nor study follow-up ; after investigator's information


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): NCT04790682


Contacts
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Contact: Cyrine EZZILI 01 47 11 16 57 cyrine.ezzili@curie.fr

Locations
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France
Hopital Ambroise Pare
Boulogne Billancourt, France, 92100
Contact: Etienne GIROUX LE PRIEUR, PR         
Principal Investigator: Etienne GIROUX LE PRIEUR, PR         
Institut Curie
Paris, France, 75005
Contact: Nicolas GIRARD, PR         
Sub-Investigator: Nicolas GIRARD, PR         
Institut Curie
Saint-cloud, France, 92210
Contact: Marie-Ange MASSIANI, DR         
Principal Investigator: Marie-Ange MASSIANI, DR         
Sponsors and Collaborators
Institut Curie
Investigators
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Study Director: Nicolas GIRARD, PR INSTITUT CURIE - Medical Oncology
Study Chair: Pierre FUMOLEAU INSTITUT CURIE - Medical Oncology
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Responsible Party: Institut Curie
ClinicalTrials.gov Identifier: NCT04790682    
Other Study ID Numbers: IC 2020-02
First Posted: March 10, 2021    Key Record Dates
Last Update Posted: March 12, 2021
Last Verified: March 2021

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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 Curie:
Lung Cancer NSCLC
metastatic stage
first-line treatment with immune checkpoint inhibitor
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms