Back to results

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

Primary Purpose

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

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

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.

About this trial

This is an interventional diagnostic trial for NSCLC Patient in a Metastatic Stage Eligible for First-line Treatment With Immune Checkpoint Inhibitor focused on measuring Lung Cancer NSCLC, metastatic stage, first-line treatment with immune checkpoint inhibitor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

No social security affiliation.
Person under legal protection.
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

Sites / Locations

Hopital Ambroise Pare
Institut CurieRecruiting
Institut CurieRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

Outcomes

Primary Outcome Measures

ctDNA variation of the prominent mutant allele variation

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

ctDNA variation of the prominent mutant allele variation

Progression-free survival

Progression-free survival according to immune cell levels in the blood

Overall survival

Overall survival according to immune cell levels in the blood

Progression-free survival

Progression-free survival according to immune cell levels variations in the blood

Overall survival

Overall survival according to immune cell levels variations in the blood

Progression-free

Progression-free survival according to ctDNA level variations.

Overall survival

Overall survival according to ctDNA level variations.

Response rate to the second line of treatment

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.

Adverse events of special interest

Adverse events of special interest of grade 3 or more (CTCAE v5.0).

Full Information

NCT ID

NCT04790682

First Posted

March 5, 2021

Last Updated

August 18, 2022

Sponsor

Institut Curie

1. Study Identification

Unique Protocol Identification Number

NCT04790682

Brief Title

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

Acronym

LIBERTYLUNG

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Recruiting

Study Start Date

May 27, 2021 (Actual)

Primary Completion Date

October 9, 2024 (Anticipated)

Study Completion Date

June 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institut Curie

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

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.

Intervention Description

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 Measure Information:

Title

ctDNA variation of the prominent mutant allele variation

Description

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

Secondary Outcome Measure Information:

Title

ctDNA variation of the prominent mutant allele variation

Description

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.

Title

Progression-free survival

Description

Progression-free survival according to immune cell levels in the blood

Time Frame