2023-509943-28-00招募中3 期
A Phase III, Double-blind, Randomised, Placebo-Controlled, International Study to assess the Efficacy and Safety of Adjuvant Osimertinib versus Placebo in Participants with EGFR mutation positive Stage IA2-IA3 Non-small Cell Lung Cancer, following Complete Tumour Resection (ADAURA2)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 21
- 试验地点
- 29
- 主要终点
- Disease free survival (DFS) in the high-risk stratum by investigators' assessment.
研究概览
简要总结
To assess the efficacy of osimertinib compared to placebo as measured by disease-free survival in participants in the high-risk stratum.
研究设计
- 分配方式
- Randomized
- 主要目的
- Study design
- 盲法
- Double (Monitor, Carer, Subject, Investigator)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Male or female, at least ≥ 18 years.
- •Females must be using highly effective contraceptive measures, and must have a negative pregnancy test prior to start of dosing if of child-bearing potential, or must have evidence of non-child-bearing potential. Male subjects must be willing to use barrier contraception.
- •NSCLC, of non-squamous histology.
- •Stage IA2 or IA3 disease, based on TNM8 classification.
- •Complete surgical resection (R0) of the primary NSCLC by lobectomy, bilobectomy, segmentectomy or sleeve resection.
- •Complete recovery from surgery at the time of randomisation. Study intervention cannot commence within 4 weeks following surgery. No more than 12 weeks may have elapsed between surgery and randomisation for participants.
- •World Health Organization performance status of 0 or
- •Provision of tumour sample for central pathology assessment of pathologic risk factors and to assess EGFR mutation status prior to randomisation.
- •A tumour which harbours one of the 2 EGFR mutations (Ex19del, L858R).
- •Minimum life expectancy of > 6 months.
排除标准
- •Mixed small cell and non-small cell cancer history.
- •Major surgery or significant traumatic injury within 4 weeks of the first dose of study intervention.
- •Participants currently receiving medications or herbal supplements known to be strong inducers of CYP3A
- •Participants with incomplete (R1/R2) resection, or who have undergone pneumonectomy or only wedge resection.
- •Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses; or active infection including HCV and HIV or active uncontrolled HBV infection.
- •History of another primary malignancy, including any known or suspected synchronous primary lung cancer, except for malignancy treated with curative intent with no known active disease ≥ 5 years before the first dose of study intervention and of low potential risk for recurrence.
- •Any of the following cardiac criteria: Mean resting QTcF interval > 470 ms, obtained from triplicate ECGs performed at screening / Any abnormalities in rhythm, conduction, or morphology of resting ECG / Any factors that increase the risk of QTcF prolongation or risk of arrhythmic events.
- •History of interstitial lung disease.
- •Inadequate bone marrow reserve or organ function.
- •Any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study intervention.
- •Prior treatment with any anticancer therapy for NSCLC (including chemotherapy, radiotherapy, immunotherapy, and EGFR-TKIs).
结局指标
主要结局
Disease free survival (DFS) in the high-risk stratum by investigators' assessment.
Disease free survival (DFS) in the high-risk stratum by investigators' assessment.
次要结局
- Disease free survival (DFS) in the overall population by investigator's assessment.
- Disease free survival (DFS) in both the high-risk stratum and overall population.
- Overall survival (OS) in participants in both the high-risk stratum and overall population.
- Impact of osimertinib versus placebo on physical functioning in both the high-risk stratum and overall population.
- Effectiveness of osimertinib versus placebo by assessment of central nervous system disease free survival (DFS) in both the high-risk stratum and the overall population.
- Characterise the pharmacokinetics of osimertinib and its metabolites (AZ13575104 [AZ5104]) in the overall population.
- Safety and tolerability profile of osimertinib versus placebo in the overall population.
研究者
AstraZeneca Clinical Study Information Center
Scientific
AstraZeneca AB
研究点 (29)
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