ACTRN12621000221853进行中（未招募）未知
An observational cohort study to assess the clinical impact of comprehensive genomic profiling in metastatic lung cancer patients (ASPiRATION).
Australian Genomic Cancer Medicine Centre0 个研究点目标入组 1,000 人开始时间: 2021年3月3日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,000
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 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Male or female patients, aged 18 years and older, with newly diagnosed pathologically confirmed metastatic non-squamous non-small cell lung cancer (mNSCLC);
- •a. Exception: patients with a typical pattern of disease recurrence within 12 months following primary resection may not require a confirmatory repeat biopsy, unless the diagnosis is unclear, such as an isolated pulmonary nodule, in which case repeat biopsy should be considered per standard practice;
- •b. For mixed or other histologies the following is permitted:
- •- Mixed adenosquamous where adenocarcinoma is dominant
- •- Carcinoma not otherwise specified (NOS) favouring adenocarcinoma
- •- Sarcomatoid carcinoma
- •2. ECOG performance status 0 or 1.
- •3. Sufficient tissue for molecular screening.
- •4. Willing and able to comply with study requirements. It is the intention to screen patients who are in principle willing to consider participation in a MoST substudy if they are found to have an appropriate tumour biomarker and are still eligible for enrolment at the time of the treatment phase;
- •5. Current enrolment or participation in another clinical study with an unregistered investigational product during the last 12 months, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study, must first be discussed the Study Team before study enrolment.
- •6. Signed, written informed consent to participate in molecular profiling and linkage to Medicare data.
- •7. Have not had any previous treatment for metastatic non-squamous NSCLC;
- •a. For patients with symptomatic or bulky disease, where it would be detrimental to delay treatment, systemic therapy may be commenced at the investigator’s discretion whilst awaiting CGP results;
- •b. Patients who have had prior treatment with curable intent are eligible.
- •8. Life expectancy of at least 12 weeks.
排除标准
- •1. Ineligible histology:
- •- Mixed small cell lung cancer
- •- Large cell neuroendocrine carcinoma
- •2. Comorbidities or conditions (e.g. psychiatric) which may contraindicate participation and/or ability to receive any systemic therapy(s);
- •3. Comorbidities or conditions that may compromise assessment of key outcomes or in the opinion of the clinician, limit the ability of the patient to comply with the protocol;
- •4. History of another primary malignancy except for:
- •a. Malignancy treated with curative intent and with no known active disease within 2 years before consent to molecular screening and of low potential risk for recurrence
- •b. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
- •c. Adequately treated carcinoma in situ without evidence of disease
研究者
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