PER-030-19已完成未知
A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER, INTERNATIONAL STUDY OF OSIMERTINIB AS MAINTENANCE THERAPY IN PATIENTS WITH LOCALLY ADVANCED, UNRESECTABLE EGFR MUTATION-POSITIVE NON-SMALL CELL LUNG CANCER (STAGE III) WHOSE DISEASE HAS NOT PROGRESSED FOLLOWING DEFINITIVE PLATINUM-BASED CHEMORADIATION THERAPY (LAURA)
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Part I Screening
- •Part I screening applies only to patients that do not have a pre-existing local positive (Exon 19
- •deletion or L858R) cobas® EGFR Mutation Test v2 (Roche Diagnostics) in a CLIA-certified
- •(USA sites) or an accredited local laboratory (sites outside of the USA) conducted according
- •to the cobas® EGFR Mutation Test v2 instructions for use.
- •Patients are eligible to be included in the study only if all of the following inclusion criteria
- •apply and none of the Part II screening exclusion criteria numbers 1, 2, 7, 9-11 and 15-20
- •Informed consent
- •1. Capable of giving signed informed consent which includes compliance with the
- •requirements and restrictions listed in the informed consent form (ICF) and in this protocol
- •2. Provision of signed and dated written informed consent for Part I screening form prior to
- •any mandatory provision of tumor samples for testing of EGFR mutation status.
- •Age and Sex
- •3. Male and Female patient must be aged at least 18 years. Patients from Japan aged at least
- •Type of patient and disease characteristics
- •4. Patients with histologically documented NSCLC of predominantly non-squamous
- •pathology who present with locally advanced, unresectable (Stage III) disease (according to
- •Version 8 of the International Association for the Study of Lung Cancer [IASLC] Staging
- •Manual in Thoracic Oncology).
- •It is recommended but not required that except for overt cT4 disease, nodal status N2
- •or N3 should have been proven by biopsy, via endobronchial ultrasound,
- •mediastinoscopy, or thoracoscopy or in absence of biopsy, should have been
- •confirmed with whole body 18F-fluoro-deoxyglucose positron emission tomography
- •(PET) plus contrast-enhanced computed tomography (CT) in addition to or in
- •combination with PET
- •5. Patient who can provide an unstained archived formalin-fixed paraffin embedded tumor
- •tissue sample in a quantity sufficient to allow for prospective central analysis of EGFR
- •mutation status.
- •Further information is provided page 50 to 54 of the protocol
排除标准
- •Part II Screening
- •Patients are eligible to be included in Part II screening process only if none of the exclusion
- •criteria apply:
- •Medical conditions
- •1. Mixed small cell and non-small cell lung cancer histology
- •2. History of interstitial lung disease (ILD) prior to chemoradiation.
- •3. Symptomatic pneumonitis following chemoradiation.
- •4. Any unresolved toxicity Common Terminology Criteria for Adverse Events (CTCAE) >
- •Grade 2 from the prior chemoradiation therapy. Patients with irreversible toxicity that is not
- •reasonably expected to be exacerbated by study drug may be included (e.g. hearing loss) after
- •consultation with the AstraZeneca medical monitor.
- •5. Any of the following cardiac criteria:
- • Mean resting corrected QT interval (QTc) >470 msec, obtained from 3 ECGs
- • Any clinically important abnormalities in rhythm, conduction, or morphology of
- •resting ECG, e.g., complete left bundle branch block, third-degree heart block, seconddegree
- •heart block.
- • Patient with any factors that increase the risk of QTc prolongation or risk of
- •arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome,
- •family history of long QT syndrome, or unexplained sudden death under 40 years of
- •age in first-degree relatives or any concomitant medication known to prolong the QT
- •interval and cause Torsades de Pointes-See section 6.5.2 for more details.
- •Further information is provided page 54 to 56 of the protocol
研究者
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