RecruitingNot ApplicableNCT04790682

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

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

Sponsor

Institut Curie

Enrollment

300 participants

Start Date

May 22, 2021

Study Type

INTERVENTIONAL

Conditions

Metastatic Lung Cancer

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is examining whether a "liquid biopsy" — a blood test that detects fragments of cancer DNA circulating in the bloodstream — can predict how well patients with advanced non-small cell lung cancer (NSCLC) will respond to immunotherapy as a first-line treatment. The goal is to find better, less invasive ways to predict treatment success. **You may be eligible if...** - You are 18 or older - You have a confirmed diagnosis of non-small cell lung cancer (NSCLC) that is advanced or metastatic (stage IV) - You have not yet received any cancer treatment for this diagnosis - Your cancer is eligible for first-line immunotherapy (immune checkpoint inhibitor) - Your cancer does not have ALK or EGFR gene mutations - Tumor tissue is available for testing **You may NOT be eligible if...** - You have already received cancer treatment - Your tumor has ALK or EGFR mutations (different treatments are available for those) - You are in poor health overall Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALassessment 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 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).