Molecular Monitoring of cfDNA by ddPCR in Non-small Cell Lung Cancer Treated by Immunotherapy.

Обзор

Non-small cell lung cancer (NSCLC) is a major public health problem. New treatments as immunotherapy can improve prognosis of patients with NCLC tumors. Nevertheless, no robust biomarker is actually available. The hypothesis of the trial is to realize a longitudinal molecular monitoring of NSCLC patients treated by immunotherapy using a quantitative analysis of cell-free DNA. The primary purposes is to study the predictive value of quantification of cell-free DNA at the first reevaluation time, on the clinical benefit, in NSCLC patients treated by immunotherapy (regardless of line, or associated treatments) The secondary purposes in this population of patients is to study the earlier predictive value (before the second treatment by immunotherapy ) of quantification of cell-free DNA, and its relationship with refractory disease and pseudo-progressive disease.

Вмешательства

• Генная терапия Molecular monitoring by quantification of cell-free DNA
  Molecular monitoring by quantification of cell-free DNA (absolute value and variation from baseline) of two house-keeping genes (RPP30, TMEM11) by droplet digital PCR, during based-immunotherapy treatments of NSCLC patients. Cell-free DNA will be extracted from 4 ml of plasma before treatments by immunotherapy, obtained from blood Streck® tubes. Quantification of house-keeping genes (or mutated genes if some are previously routinely identified in tumor tissue) by ddPCR.

Первичные конечные точки

• Predictive value of quantification of cell-free DNA from plasma at the time of the first radiological evaluation, on clinical benefit [Срок оценки: Inclusion visit - visit 2 (day 60)]

Вторичные конечные точки (1)

• Study of the earlier predictive value (before the second treatment by immunotherapy ) of quantification of cell-free DNA, and its relationship with refractory disease and pseudo-progressive disease. [Срок оценки: Inclusion visit, visit 1 (day 15), visit 2 (day 60), visit 3 (day 180), visit 4 (day 270), visit 5 (day 360), visit 6 (day 720), or early termination visit (in case of progression with end of immunotherapy)]

Критерии участия

Критерии включения

• age over 18
• informed of the objectives of the project and signed consent
• non small cell lung cancer, stage IIIA, IIIB or IV
• PS (WHO performance status) < or =2
• treatment based on immunotherapy (monotherapy or combination)
• at least one measurable target
• available results of PD-L1 expression

Критерии исключения

• concomitant other type of cancer
• another cancer in the last 5 years

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

Другое

Центры проведения

Франция · 8 центров

• CHU de Besancon - Service de pneumologie — Besançon
• Hopitaux Civils de Colmar - service de Pneumologie — Colmar
• CHU de Dijon - service de Pneumologie — Dijon
• CLCC Georges-François Leclerc — Dijon
• GHR Mulhouse Sud-Alsace - Service de Pneumologie — Mulhouse
• CHU de Reims - service de Pneumologie — Reims
• CHRU de Strasbourg — Strasbourg
• Institut de Cancérologie de Lorraine — Vandœuvre-lès-Nancy

Идентификаторы

NCT: NCT04720339 · 7652

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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