NCT04790682

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Institut Curie · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Metastatic Lung Cancer

Interventions

Type	Name	Description
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 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).

Timeline

• Start date: 2021-05-22
• Primary completion: 2029-06-03
• Completion: 2030-06-03
• First posted: 2021-03-10
• Last updated: 2025-09-18

Locations

3 sites across 1 country: France