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临床试验/EUCTR2021-004135-89-DE
EUCTR2021-004135-89-DE招募中1 期

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

AstraZeneca AB0 个研究点目标入组 380 人开始时间: 2021年12月7日最近更新:
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试验速览

阶段
1 期
状态
招募中
入组人数
380
研究概览入排标准研究者记录与标识符相似试验

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

性别
All

入选标准

  • •1. Male or female, at least = 18 years.
  • •2. NSCLC, of non-squamous histology.
  • •3. Stage IA2 or IA3 disease, based on TNM8 classification.
  • •4. Complete surgical resection (R0) of the primary NSCLC by lobectomy, bilobectomy, segmentectomy or sleeve resection.
  • •5. 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.
  • •6. World Health Organization performance status of 0 or 1.
  • •7. Provision of tumour sample for central pathology assessment of pathologic risk factors and to assess EGFR mutation status prior to randomisation.
  • •8. A tumour which harbours one of the 2 EGFR mutations (Ex19del, L858R).
  • •9. Minimum life expectancy of > 6 months.
  • •10. 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.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 190
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 190

排除标准

  • •1. Mixed small cell and non-small cell cancer history.
  • •2. Participants with incomplete (R1/R2) resection, or who have undergone pneumonectomy, or only wedge resection.
  • •3. 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..
  • •4. 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.
  • •5. 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.
  • •6. History of interstitial lung disease.
  • •7. Inadequate bone marrow reserve or organ function.
  • •8. Any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study intervention.
  • •9. Prior treatment with any anticancer therapy for NSCLC (including chemotherapy, radiotherapy, immunotherapy, and EGFR-TKIs).
  • •10. Major surgery or significant traumatic injury within 4 weeks of the first dose of study intervention.
  • •11. Participants currently receiving medications or herbal supplements known to be strong inducers of CYP3A4.

研究者

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