LIquid Biopsy to prEdict Responses To First-line immunotherapY in Metastatic Non-small Cell LUNG Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- ctDNA variation of the prominent mutant allele variation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
- •Signed informed consent of the patient.
排除标准
- •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
研究组 & 干预措施
NSCLC patient in a metastatic stage eligible for 1st-line TT with immune checkpoint inhibitor.
Patient with histologically proven Non Small Cell Lung Cancer 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.
干预措施: 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. (Biological)
结局指标
主要结局
ctDNA variation of the prominent mutant allele variation
时间窗: 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 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.
次要结局
- Progression-free(End of study)
- Survival (FS)(End of study)
- Survival(End of study)
- Response rate to the second line of treatment(End of study)
- Overall survival(End of study)
- ctDNA variation of the prominent mutant allele variation(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(End of study)
- Survival (OS)(End of study)
- Adverse events of special interest(End of study)