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

NCT04790682 | Recruiting

• 1 other identifier: IC 2020-02
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 3

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.

Conditions

Metastatic Lung Cancer

Keywords

Lung Cancer NSCLC; metastatic stage; first-line treatment with immunotherapy

Outcome Measures

Primary Outcomes (1)

• 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.

  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 Outcomes (9)

• ctDNA variation of the prominent mutant allele variation

  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.

• Free survival

  End of study

• Overall survival

  End of study

• Survival (FS)

  End of study

• Survival (OS)

  End of study

Study Arms (1)

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

EXPERIMENTAL

Patient with histologically proven Non Small Cell Lung Cancer 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.

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.

Interventions

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. BIOLOGICAL

* 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).

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Curie: lead

Study Sites (3)

Hopital Ambroise Pare

Boulogne-Billancourt, 92100, France

RECRUITING

Institut Curie

Paris, 75005, France

RECRUITING

Institut Curie

Saint-Cloud, 92210, France

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Nicolas GIRARD, PR

  INSTITUT CURIE - Medical Oncology

  STUDY DIRECTOR

• Pierre FUMOLEAU

  INSTITUT CURIE - Medical Oncology

  STUDY CHAIR

Central Study Contacts

Marie-Emmanuelle Legrier

CONTACT

01 56 24 56 49; marieemmanuelle.legrier@curie.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2021
• First Posted: March 10, 2021
• Study Start: May 22, 2021
• Primary Completion (Estimated): June 3, 2029
• Study Completion (Estimated): June 3, 2030
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.
• Access Criteria: Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).

Locations

FR (3)