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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms

  • Lung Neoplasms
  • NSCLC Patient in a Metastatic Stage Eligible for First-line Treatment With Immune Checkpoint Inhibitor

NCT number NCT04790682
Study type Interventional
Source Institut Curie
Contact Cyrine EZZILI
Phone 01 47 11 16 57
Email cyrine.ezzili@curie.fr
Status Recruiting
Phase N/A
Start date May 27, 2021
Completion date June 1, 2026