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

  • STATUS
    Recruiting
  • End date
    May 1, 2024
  • participants needed
    300
  • sponsor
    Institut Curie
Updated on 20 July 2021

Summary

Patient with histologically proven NSCLC in a metastatic stage, treatment nave 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.

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.

Details
Condition NSCLC Patient in a Metastatic Stage Eligible for First-line Treatment With Immune Checkpoint Inhibitor
Treatment 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.
Clinical Study IdentifierNCT04790682
SponsorInstitut Curie
Last Modified on20 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Histologically-proven NSCLC
Age 18 years
Advanced or metastatic stage IV
Treatment-nave 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
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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