Spanish Lung Liquid vs. Invasive Biopsy Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 186
- 试验地点
- 7
- 主要终点
- Non-inferiority of cell free DNA (cfDNA)-based versus tumor tissue-based genotyping
研究概览
简要总结
Tumor Derived cell free DNA (cfDNA) is increasingly used in the clinic to obtain genotype information about lung cancer, but its concordance with concurrent tumor-derived sequenced data is not known. The primary objective of this study is to demonstrate the non-inferiority of cfDNA-based versus tumor tissue-based genotyping.
详细描述
Primary objective:
To demonstrate the non-inferiority of cfDNA-based versus tumor tissue-based genotyping as it pertains to the detection of clinically-actionable biomarkers in first line, treatment naïve, metastatic non-squamous NSCLC.
The following secondary objectives will be studied:
- Turn around Time (TAT) of cfDNA vs. tissue results.
- Time to treatment (TtT) initiation.
- Quantity not sufficient rate (QNS) of tissue for clinically-actionable biomarker testing.
- Tumor Not Detected (TND) rate of cfDNA in blood.
- Rescue rate of QNS samples using cfDNA-derived genotyping.
- Rate response for patients that are actionable biomarker positive (either in cDNA or tissue) treated with target-drugs according investigator criteria. Up to three RECIST assessments per patient will be retrospectively done by external personnel (no investigational team).
- Rate of discovery of genomically mediated, acquired resistance to targeted therapies in the biomarker-positive subsets.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
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
- •Patients biopsy-proven, metastatic, previously untreated, non-squamous non-small cell lung cancer (NSCLC). Patients may have received adjuvant cytotoxic chemotherapy, but not targeted neo-adjuvant or adjuvant therapy.
- •Age ≥ 18 years
- •Ability to understand a written informed consent document, and the willingness to sign it.
- •Willingness to provide blood sample at the time points defined in Table 1 [pre-treatment, Day 14 (+/- 7 days) and End of Study].
- •Patient has or will have standard-of-care tissue genotyping ordered.
- •Stable Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
排除标准
- •Pregnancy, recorded from clinical records
- •Any concurrent, non-cutaneous, malignancy (with the exception of early stage non-invasive cervical cancer). Any prior cancer must have occurred more than 5 years prior with no evidence of currently active disease
结局指标
主要结局
Non-inferiority of cell free DNA (cfDNA)-based versus tumor tissue-based genotyping
时间窗: From date of inclusion until 12 months from enrollment follow-up or upon progression, death or withdrawal from study participation, whichever occurs first.
Demonstrate the non-inferiority of cell free DNA (cfDNA)-based versus tumor tissue-based genotyping as it pertains to the detection of clinically-actionable biomarkers in first line, treatment naïve, metastatic non-squamous Non-small cell lung cancer (NSCLC).
次要结局
- Rate of discovery of genomically mediated, acquired resistance to targeted therapies(From visit 0 until month 12 or upon progression, whichever occurs first)
- Turn around Time (TAT) of cell free DNA (cfDNA) vs. tissue results(From pre-treatment visit until month 12 or upon progression, whichever occurs first)
- Time to treatment (TtT) initiation(From the date of enrollment in the study until D1 (treatment initiation))
- Quantity not sufficient rate (QNS) of tissue(From day 0 to pre-treatment visit)
- Tissue Incomplete (TI) rate of tissue(From day 0 to pre-treatment visit)
- Tumor Not Detected (TND) rate of cell free DNA (cfDNA)(From pre-treatment visit until month 12 or upon progression, whichever occurs first)
- Rate response for patients that are actionable biomarker positive (either in cell DNA (cDNA) or tissue) treated with target-drugs(From visit 0 until month 12 or upon progression, whichever occurs first)
- Rescue rate of Quantity not sufficient (QNS) samples using cell free DNA (cfDNA)-derived genotyping(From pre-treatment visit until month 12 or upon progression, whichever occurs first)