NL-OMON56117尚未招募不适用
MASTER SCREENING STUDY TO DETERMINE BIOMARKER STATUS AND POTENTIAL TRIAL ELIGIBILITY FOR PATIENTS WITH MALIGNANT TUMORS - BX43361 - NSCLC Platform screening study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •General Inclusion Criteria
- •Patients must meet the following criteria for study entry:
- •- Signed Informed Consent Form
- •- Age 18 years or above at time of signing Informed Consent Form
- •- Given that the aim of Study BX43361 is to assign patients to a
- •biomarker-appropriate linked Roche clinical trial:
- •- Awareness of and willingness, in principle, to participate in an assigned
- •cohort of a linked Roche clinical trial
- •- Ability to comply with future investigational treatment protocol procedures
- •in the investigator*s judgment and based on discussion with the patient, for
- •example, dosing of medication (e.g., oral or IV), tumor assessments, safety
- •monitoring, agreement to meet contraceptive requirements, and completion of
- •questionnaires
- •- Confirmed availability of a representative formalin-fixed, paraffin-embedded
- •(FFPE) tumor specimen.
- •- Adequate hematologic and end-organ function by the investigator*s clinical
- •judgement, including the following:
- •- No clinically significant hematologic (CBC), coagulation, or biochemistry
- •test results
- •- No indications and/or known history of clinically significant acute or
- •chronic liver, or kidney injury
- •Stage-Specific Inclusion Criteria
- •Patients with Stage III NSCLC
- •Patients with Stage III NSCLC must meet the following criteria for study entry:
- •- 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 with plans to receive, currently receiving, or received chemoradiation
- •- Representative FFPE tumor specimen obtained prior to the start of any
- •chemoradiotherapy
- •- Eastern Cooperative Oncology Group (ECOG) Group Performance Status of 0, 1, or
- •Patients with Stage II, IIIA or Select IIIB (T3N2 only) NSCLC Requiring
- •Adjuvant Treatment
- •Patients with Stage I to IIIA NSCLC must meet the following criteria for study
- •- Stage I to IIIA NSCLC based on the 8th edition of the AJCC and UICC cancer
- •staging system
- •- 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 patient treatment pathway as possible to ensure
- •the patient is potentially eligible for all cohorts
- •Representative FFPE tumor specimen obtained prior to the start of
- •o For patients enrolled following surgery:
- •These patients should achieve complete resection of histologically confirmed
- •Stage I to Stage IIIA with all surgical margins testing negative for tumor.
- •o It is strongly recommended that patients should be enrolled no more than 8
- •weeks after surgery, and prior to post-operative chemotherapy (as applicable).
- •Investigators should make reference to the relevant linked Roche clinical trial
- •protocol to ensure sufficient time is given to subsequently screen the patient
- •within the linked trial for biomarker-eligible patients identified.
- 另有 4 项未显示
排除标准
- •General Exclusion Criteria
- •Patients who meet any of the following criteria will be excluded from study
- •- Pregnant or breastfeeding, or intending to become pregnant during the study
- •Women of childbearing potential who are required (and have consented) to have a
- •study-mandated procedure for which pregnancy would impact the risks to the
- •patient and/or fetus per local guidelines must have a negative serum pregnancy
- •test result within 7 days prior to the procedure.
- •- History of malignancy other than NSCLC within 5 years prior to screening,
- •except for malignancies with a negligible risk of metastasis or death
- •- Any other disease, metabolic dysfunction, physical examination finding, or
- •clinical laboratory finding that contraindicates the use of an investigational
- •drug, may affect the interpretation of the results, or may render the patient
- •at high risk from treatment complications. This includes any of the following:
- •o Known clinically significant liver disease (e.g., active viral, alcoholic, or
- •other hepatitis; cirrhosis; current alcohol abuse)
- •o Significant cardiovascular disease (e.g., New York Heart Association Class II
- •or greater cardiac disease, myocardial infarction, or cerebrovascular accident)
- •within 3 months prior to enrollment, unstable arrhythmia, or unstable angina
- •- Recent major surgical procedure or anticipation of a need for a major
- •surgical procedure, except for patients who have recently had and have adequate
- •healing after complete surgical resection of tumor
- •- Prior allogeneic stem-cell or solid-organ transplantation
- •- Recent or ongoing severe or clinically significant infection, including but
- •not limited to, hospitalization for complications of infection, bacteremia, or
- •severe pneumonia
研究者
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