NCT05419375已完成2 期
Master Screening Study to Determine Biomarker Status and Potential Trial Eligibility for Patients With Malignant Tumors
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 470
- 试验地点
- 209
- 主要终点
- Proportion of participants with evaluable biomarker results
研究概览
简要总结
The study objective is to determine the biomarker status of a participant's tumor tissue and use that status to determine eligibility for a linked Roche clinical trial.
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
- •General Inclusion Criteria:
- •Confirmed availability of a representative formalin-fixed, paraffin-embedded (FFPE) tumor specimen meeting criteria defined in the protocol
- •Considered by principal investigator (PI) to be a candidate for a linked clinical trial with an investigational medicinal product, and that the participant has the awareness and willingness to participate in said trial
- •Inclusion Criteria for Participants with Stage III NSCLC
- •Locally advanced, unresectable Stage III NSCLC of either squamous or non-squamous histology based on 8th edition of the American Joint Committee on Cancer (AJCC) and Union for International Cancer Control (UICC) cancer staging system
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- •Inclusion Criteria for Participants with Stage II, IIIA, or Select IIIB (T3N2 only) NSCLC Requiring Adjuvant Treatment
- •Stage II, IIIA, or select IIIB (T3N2 only) NSCLC based on the 8th edition of the AJCC and UICC cancer staging system (Amin et al. 2017)
- •Considered eligible for curative intent surgery (complete resection with all surgical margins testing negative for tumor)
- •Screening within Study BX43361, using a pretreatment biopsy, is encouraged to be performed as early in the participant treatment pathway as possible to ensure the participant is potentially eligible for all cohorts, and should meet guidelines as defined by the protocol
- •Representative FFPE tumor specimen obtained prior to the start of any treatment
- •ECOG Performance Status of 0 or 1
排除标准
- •History of malignancy other than NSCLC within 5 years prior to screening, except for malignancies with a negligible risk of metastasis or death
- •Any condition that may affect the interpretation of study results
- •Significant liver or cardiovascular disease
- •Prior allogenic stem-cell or solid-organ transplantation
研究组 & 干预措施
Non-Small Cell Lung Cancer (NSCLC)
Other
Participants with NSCLC will be screened for biomarker eligibility for a linked Roche study.
干预措施: Screening platform (Other)
结局指标
主要结局
Proportion of participants with evaluable biomarker results
时间窗: Up to 10 years
Proportion of participants eligible for a linked Roche clinical trial
时间窗: Up to 10 years
次要结局
未报告次要终点
研究者
研究点 (209)
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