LIquid Biopsy to prEdict Responses To First-line immunotherapY in Metastatic Non-small Cell LUNG Cancer. LIBERTY LUNG
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 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..
- Who it may be relevant to
- Registry conditions: Metastatic Lung Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
LIquid Biopsy to prEdict Responses To First-line immunotherapY in Metastatic Non-small Cell LUNG Cancer
Overview
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.
Interventions
- 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.
* 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 a
Primary outcome measures
- 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]
Secondary outcome measures (9)
- 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.]
- Free survival [Time frame: End of study]
- Overall survival [Time frame: End of study]
- Survival (FS) [Time frame: End of study]
- Survival (OS) [Time frame: End of study]
- Progression-free [Time frame: End of study]
- Survival [Time frame: End of study]
- Response rate to the second line of treatment [Time frame: End of study]
- Adverse events of special interest [Time frame: End of study]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
France · 3 centers
- Hopital Ambroise Pare — Boulogne-Billancourt
- Institut Curie — Paris
- Institut Curie — Saint-Cloud
Identifiers
NCT: NCT04790682 · IC 2020-02