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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
300
* 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).
Hopital Ambroise Pare
Boulogne-Billancourt, France
RECRUITINGInstitut Curie
Paris, France
RECRUITINGInstitut Curie
Saint-Cloud, France
RECRUITINGctDNA variation of the prominent mutant allele variation
ctDNA variation of the prominent mutant allele variation between baseline and week 6, 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.
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
ctDNA variation of the prominent mutant allele variation
ctDNA variation of the prominent mutant allele variation between baseline and week 6, 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.
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
Progression-free survival according to immune cell levels in the blood
Time frame: End of study
Overall survival
Overall survival according to immune cell levels in the blood
Time frame: End of study
Survival (FS)
Progression-free survival according to immune cell levels variations in the blood
Time frame: End of study
Survival (OS)
Overall survival according to immune cell levels variations in the blood
Time frame: End of study
Progression-free
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Progression-free survival according to ctDNA level variations.
Time frame: End of study
Survival
Overall survival according to ctDNA level variations.
Time frame: End of study
Response rate to the second line of treatment
Response rate to the second line of treatment based on RECIST 1.1 and iRECIST criteria according to ctDNA level at week 6 of the second line of treatment.
Time frame: End of study
Adverse events of special interest
Adverse events of special interest of grade 3 or more (CTCAE v5.0).
Time frame: End of study