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NCT Number: NCT04790682

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

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.

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Key information

Conditions

Metastatic Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Ambroise Pare, Boulogne-Billancourt, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  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 outcomes

  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. Free survival

    Time frame: End of study

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

  3. Overall survival

    Time frame: End of study

    Overall survival according to immune cell levels in the blood

  4. Survival (FS)

    Time frame: End of study

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

  5. Survival (OS)

    Time frame: End of study

    Overall survival according to immune cell levels variations in the blood

  6. Progression-free

    Time frame: End of study

    Progression-free survival according to ctDNA level variations.

  7. Survival

    Time frame: End of study

    Overall survival according to ctDNA level variations.

  8. Response rate to the second line of treatment

    Time frame: End of study

    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: End of study

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

Study contacts

Contact information is provided by the study sponsor or research team.

Marie-Emmanuelle Legrier

CONTACT

[email protected]

01 56 24 56 49

Sponsors and collaborators

Lead sponsor

Institut Curie

Other

Registry information

Official study title

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

Acronym: LIBERTYLUNG

Important dates

Study start
2021
Primary completion
2029
Study completion
2030
First posted
Mar 10, 2021
Registry last updated
Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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