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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Биопрепарат 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

Первичные конечные точки

• ctDNA variation of the prominent mutant allele variation [Срок оценки: 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]

Вторичные конечные точки (9)

• ctDNA variation of the prominent mutant allele variation [Срок оценки: 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 [Срок оценки: End of study]
• Overall survival [Срок оценки: End of study]
• Survival (FS) [Срок оценки: End of study]
• Survival (OS) [Срок оценки: End of study]
• Progression-free [Срок оценки: End of study]
• Survival [Срок оценки: End of study]
• Response rate to the second line of treatment [Срок оценки: End of study]
• Adverse events of special interest [Срок оценки: End of study]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Франция · 3 центра

• Hopital Ambroise Pare — Boulogne-Billancourt
• Institut Curie — Paris
• Institut Curie — Saint-Cloud

Идентификаторы

NCT: NCT04790682 · IC 2020-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗