Clinical Trials /

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

NCT04790682

Description:

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.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: LIquid Biopsy to prEdict Responses To First-line immunotherapY in Metastatic Non-small Cell LUNG Cancer. LIBERTY LUNG
  • Official Title: LIquid Biopsy to prEdict Responses To First-line immunotherapY in Metastatic Non-small Cell LUNG Cancer

Clinical Trial IDs

  • ORG STUDY ID: IC 2020-02
  • NCT ID: NCT04790682

Conditions

  • NSCLC Patient in a Metastatic Stage Eligible for First-line Treatment With Immune Checkpoint Inhibitor

Interventions

DrugSynonymsArms
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.NSCLC patient in a metastatic stage eligible for 1st-line TT with immune checkpoint inhibitor.

Purpose

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.

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.
    

Trial Arms

NameTypeDescriptionInterventions
NSCLC patient in a metastatic stage eligible for 1st-line TT with immune checkpoint inhibitor.Experimental
  • 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.

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure: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
Safety Issue:
Description: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

Measure: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.
Safety Issue:
Description: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.
Measure:Progression-free survival
Time Frame:6 weeks after progression after first-line treatment or a maximum of 21 months
Safety Issue:
Description:Progression-free survival according to immune cell levels in the blood
Measure:Overall survival
Time Frame:6 weeks after progression after first-line treatment or a maximum of 21 months
Safety Issue:
Description:Overall survival according to immune cell levels in the blood
Measure:Progression-free survival
Time Frame:6 weeks after progression after first-line treatment or a maximum of 21 months
Safety Issue:
Description:Progression-free survival according to immune cell levels variations in the blood
Measure:Overall survival
Time Frame:6 weeks after progression after first-line treatment or a maximum of 21 months
Safety Issue:
Description:Overall survival according to immune cell levels variations in the blood
Measure:Progression-free
Time Frame:6 weeks after progression after first-line treatment or a maximum of 21 months
Safety Issue:
Description:Progression-free survival according to ctDNA level variations.
Measure:Overall survival
Time Frame:6 weeks after progression after first-line treatment or a maximum of 21 months
Safety Issue:
Description:Overall survival according to ctDNA level variations.
Measure:Response rate to the second line of treatment
Time Frame:6 weeks after progression after first-line treatment or a maximum of 21 months
Safety Issue:
Description: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.
Measure:Adverse events of special interest
Time Frame:6 weeks after progression after first-line treatment or a maximum of 21 months
Safety Issue:
Description:Adverse events of special interest of grade 3 or more (CTCAE v5.0).

Details

Phase:N/A
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Institut Curie

Trial Keywords

  • Lung Cancer NSCLC
  • metastatic stage
  • first-line treatment with immune checkpoint inhibitor

Last Updated

March 12, 2021