CTRI/2021/04/032961招募中3 期
A Phase III, Randomised, Controlled, Multi-centre, 3-Arm Study of Neoadjuvant Osimertinib as Monotherapy or in Combination with Chemotherapy versus Standard of Care Chemotherapy Alone for the Treatment of Patients with Epidermal Growth Factor Receptor Mutation Positive, Resectable Non-small Cell Lung CancerNEOADAURA
试验速览
- 阶段
- 3 期
- 状态
- 招募中
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
- •Patients are eligible to be included in the study only if all of the following inclusion criteria and none of the exclusion criteria apply:
- •Informed consent
- •1Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
- •2Provision of signed and dated written ICF prior to any mandatory study specific procedures, sampling, and analyses.
- •3For patients who agree to the optional genetic testing, provision of signed and dated written Optional Genetic Research Information informed consent prior to collection of samples for optional genetic research that supports Genomic Initiative (as allowed per local regulations).
- •Age and Sex
- •4Male or female, at least 18 years of age. For patients aged <20 years and enrolled in Japan, a written informed consent should be obtained from the patient and his or her legally acceptable representative.
- •Type of patient and disease characteristics
- •5Histologically or cytologically documented non-squamous NSCLC with completely resectable (Stage II -IIIB N2) disease (according to Version 8 of the IASLC Cancer Staging Manual
- •6Complete surgical resection of the primary NSCLC must be deemed achievable, as assessed by a MDT evaluation (which should include a thoracic surgeon, specialised in oncologic procedures).
- •7Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1 at enrolment, with no deterioration over the previous 2 weeks prior to baseline or day of first dosing.
- •8Adequate organ and marrow function as defined below:
- •a.Haemoglobin: =9.0 g/dL
- •b.Absolute neutrophil count: =1.5 × 109/L
- •c.Platelet count: =100 × 109/L.
- •Note: The use of granulocyte colony stimulating factor (G-CSF) support, platelet transfusion and blood transfusions to meet these criteria is not permitted.
- •d.Serum bilirubin: =1.5 × the upper limit of normal (ULN). This will not apply to patients with confirmed Gilbert s syndrome (unconjugated hyperbilirubinemia), who will be allowed in consultation with their physician.
- •e.ALT and AST: =2.5 × ULN.
- •f.Creatinine clearance =50 mL/min calculated by Cockcroft and Gault equation.
- •9Life expectancy of >6 months prior to randomisation.
- •Tumour sample requirements
- •10A tumour which harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either alone or in combination with other EGFR mutations (ie, T790M, G719X, Exon20 insertions, S7681 and L861Q).
- •Reproduction
- •11Female patients who are not abstinent (in line with the preferred and usual lifestyle choice of the patient) and intend to be sexually active with a male partner must be using highly effective contraceptive measures, and must have a negative pregnancy test prior to first dose of any study treatment if they are of child-bearing potential; or must have evidence of non-child-bearing potential by fulfilling 1 of the following criteria at screening:
- •a.Post-menopausal, defined as more than 50 years of age and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments
- •b.Women under 50 years old would be considered as postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatments and have luteinizing hormone (LH) and follicle-stimulating hormon
排除标准
- •Medical conditions
- •1History of allogeneic organ transplantation
- •2Any evidence of severe or uncontrolled systemic diseases (as judged by the Investigator), including uncontrolled hypertension and active bleeding diatheses, which in the Investigator s opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol; or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). Active infection will include any patients receiving intravenous treatment for infection; active hepatitis B infection will, at a minimum, include all patients who are Hepatitis B surface antigen positive (HbsAg positive) based on serology assessment. Screening for chronic conditions is not required.
- •3Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD.
- •4History of another primary malignancy, except for the following:
- •I.Malignancy treated with curative intent and with no known active disease =2 years before the first dose of investigational product (IP) and of low potential risk for recurrence
- •II.Adequately treated non-melanoma skin cancer or lentigo malignancy without evidence of disease
- •III.Adequately treated carcinoma in situ without evidence of disease.
- •5History of active primary immunodeficiency.
- •6Patients who have pre-operative radiotherapy treatment as part of their care plan.
- •7Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of osimertinib.
- •8Mixed small cell and NSCLC histology.
- •9Stages I, IIIB N3, IIIC, IVA, and IVB NSCLC.
- •10T4 tumours infiltrating the aorta, the oesophagus and/or the heart; and/or any bulky N2 disease.
- •11Patients who are candidates to undergo only segmentectomies or wedge resections.
- •12Any of the following cardiac criteria:
- •I.Mean resting corrected QT interval (QTc) > 470 msec obtained from 3 electrocardiograms (ECGs), using the screening clinic ECG machine-derived QTcF value or by manual calculation;
- •II.Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG eg, complete left bundle branch block, second-degree heart block, and third-degree heart block;
- •III.Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as electrolyte abnormalities including serum/plasma potassium, magnesium and calcium below the LLN, heart failure, 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 Pointe.
- •correction of electrolyte abnormalities to within normal ranges can be performed during screening
- •13Currently pregnant (confirmed with positive pregnancy test) or breast-feeding.
- •Prior/concomitant therapy
- •14Prior treatment with any systemic anti-cancer therapy for NSCLC including chemotherapy, biologic therapy, immunotherapy, or any investigational drug
- •15Prior treatment with EGFR-TKI therapy
- •16Current use of (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal
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