Prediction in Silico of Therapeutic Response in a Prospective Cohort Study of Metastatic Lung Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- Overall survival
研究概览
简要总结
RATIONALE : Currently, the mechanisms associated with the response or resistance to treatment are poorly understood and are multifactorial. These mechanisms involve clinical and biological factors associated with the host and the tumor and possibly the patient's psycho-social environment.
PURPOSE : This trial will assess the use of a prospective database dedicated to patients with breast cancers that contains clinical data as well as epidemiological, psychological, emotional, social, imaging, biological and biopathological data. These data will allow a creation of new modelling algorithms in order to predict response and resistance to treatment.
详细描述
This prospective study will be conducted on first line metastatic lung cancer patients. Three phenotypic groups are identified on immunohistochemistry done at inclusion: on metastatic sites or lung tumor if local recurrence, usual treatment protocols are often guided by the following groups:
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For group 1: SCLC (small cell lung cancer)
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Carbo or cisplatin + etoposide chemotherapy associated to atezolizumab or durvalumab
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For group 2: NSCLC (no small cell lung cancer) without oncogenic addiction:
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Adenocarcinoma, NOS, sarcomatoïd carcinoma or large cell carcinoma with PDL1 expression level ≥ 50%: Carbo/cisplatin + pemetrexed + pembrolizumab or pembrolizumab alone.
In case of contra indication of pembrolizumab, treatment will be based on doublet of chemotherapy with platinum salt +/- bevacizumab - Adenocarcinoma, NOS, sarcomatoïde carcinoma or large cell carcinoma with PDL1 expression level < 50%: Carbo/cisplatin + pemetrexed + pembrolizumab.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Written informed consent obtained from the patient prior to performing any protocol-related procedures, including screening biopsy, blood sample and questionnaires
- •18 years old at time of written consent
- •Patient with histologically confirmed lung cancer
- •Lung cancer metastatic disease or locally advanced not eligible for local curative treatment intent
- •Performance status ≤ 2 (according to WHO criteria)
- •Indication of any systemic therapeutic strategy can be performed alongside this current cohort in accordance with national and / or international recommendations.
- •Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
- •Patient must be affiliated to a Social Health Insurance
排除标准
- •Other malignancy treated within the last 3 years (except non-melanoma skin cancer or in situ carcinoma of the cervix)
- •Other neuroendocrine tumour than small cell or large cell carcinoma.
- •Pregnant or nursing patient
- •Individual deprived of liberty or placed under the authority of a tutor
- •Impossibility to submit to the medical follow-up of this clinical trial for geographical, social or psychological reasons
结局指标
主要结局
Overall survival
时间窗: 15 years
Overall Survival is defined by the delay between the date of inclusion and the date of death or last follow-up assessment
次要结局
- To describe response to treatment for each therapeutic sequence(15 years)
- To evaluate progression free survival (PFS) for each therapeutic sequence(15 years)