A phase III multicenter, randomized study of oral LDK378versus standard chemotherapy in previously untreatedadult patients with ALK rearranged (ALK-positive), stageIIIB or IV, non-squamous non-small cell lung cancer - ASCEND 4

ovartis Healthcare Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

阶段: 3 期
状态: 进行中（未招募）
发起方

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

入选标准

•1. Patient has a histologically or cytologically confirmed diagnosis of non-squamous NSCLC
•that is ALK positive as assessed by the Ventana IHC test. The test will be performed at
•Novartis designated central laboratories
•2. Patient has newly diagnosed stage IIIB or IV NSCLC or relapsed locally advanced or metastatic NSCLC not previously treated with any systemic anti-cancer therapy (e.g. cytotoxic drugs, monoclonal antibody therapy, crizotinib or other ALK inhibitors, or other targeted therapies, either experimental or not), with exception of neo-adjuvant or adjuvant therapy as depicted in criterion 6. (For AJCC stage groupings and TNM definitions, refer to NCI 2012 guidelines)
•3. Patient has at least one measurable lesion as defined by RECIST 1.1. A previously irradiated site lesion may only be counted as a target lesion if there is clear sign of progression since the irradiation.
•4. Patient with clinically and neurologically stable central nervous system metastases
•who have not required increasing doses of steroids within the 2 weeks prior to screening to manage CNS symptoms
•5. Patient is 18 years of age or older at the time of informed consent.
•6. Patient who received previous neo-adjuvant or adjuvant systemic therapy will be eligible
•for enrollment only if relapse has occurred more than 12 months from the end of the neoadjuvant
•or adjuvant systemic therapy. Patients must have recovered from all toxicities related to prior (neo-) adjuvant systemic therapy to grade less than or eual to 1 (CTCAE v 4.03). Exception
•to this criterion: patients with any grade of alopecia are allowed to enter the study.
•7. Patient must meet the following laboratory values at the screening visit:
•WBC count greater than or equal to 4 x 10 raised to 9 per L
•Absolute Neutrophil Count greater than or equal to 1.5 x 10 raised to 9 per L
•Platelets greater than or equal to 100 x 10 raised to 9 per L
•Hemoglobin (Hgb) greater than or equal to 9 g per dL
•Serum creatinine less than 1.5 mg per dL and /or calculated creatinine clearance (using
•Cockcroft-Gault formula) greater than or equal to 50 mL per min
•Total bilirubin less than 1.5 x ULN except for patients with Gilbertâ??s syndrome who may
•only be included if total bilirubin less than 3 x ULN or direct bilirubin less than 1.5 x ULN
•Aspartate transaminase (AST) less than 2.5 x ULN, except for patients with liver metastasis,
•who are only included if AST less than 5 x ULN
•Alanine transaminase (ALT) less than 2.5 x ULN, except for patients with liver metastasis,
•who are only included if ALT less than 5 x ULN
•Alkaline phosphatase (ALP) less than 5 x ULN
•8. Patient must have the following laboratory values greater than or equal to lower limit of normal (LLN) or corrected to within normal limits with supplements during screening:
•Potassium greater than or equal to LLN
•Magnesium greater than or equal to LLN
•Phosphorus greater than or equal to LLN
•Total calcium (corrected for serum albumin) greater than or equal to LLN
•9. Patient has life expectancy greater than or equal to 12 weeks.
•10. Patient has a WHO performance status 0-2.
•11. Patient has the ability to understand and provide signed informed consent.

排除标准

•1. Patient with known hypersensitivity to any of the excipients of LDK378 (microcrystalline
•cellulose, mannitol, crospovidone, colloidal silicon dioxide and magnesium stearate)
•2. Patient with a history of severe hypersensitivity reaction to platinum containing drugs, pemetrexed or any known excipients of these drugs.
•3. Patient has received previous systemic anticancer therapy (e.g. cytotoxic drugs,
•monoclonal antibody therapy, crizotinib or other ALK inhibitors, or other targeted
•therapies, either experimental or not) for newly diagnosed stage IIIB or IV NSCLC or
•relapsed locally advanced or metastatic NSCLC with exception of neo-adjuvant or
•adjuvant therapy as depicted in inclusion criteria 6.
•4. Patient with symptomatic CNS metastases who is neurologically unstable or has required
•increasing doses of steroids within the 2 weeks prior to screening to manage CNS
•5. Patient has history of carcinomatous meningitis.
•6. Patient has received radiotherapy less than or equal to 2 weeks prior to starting the study treatment or has not recovered from radiotherapy-related toxicities. Palliative radiotherapy for bone lesions less than or equal to 2 weeks prior to starting study treatment is allowed.
•7. Patient has had major surgery (e.g., intra-thoracic, intra-abdominal or intra-pelvic) within
•4 weeks prior (2 weeks for resection of brain metastases) to starting study treatment or has
•not recovered from side effects of such procedure. Video-assisted thoracic surgery
•(VATS) and mediastinoscopy will not be counted as major surgery and patients can receive study treatment greater than or equal to 1 week after the procedure.
•8. Patient with a concurrent malignancy or history of a malignant disease other than NSCLC
•that has been diagnosed and/or required therapy within the past 3 years. Exceptions to this
•exclusion include the following: completely resected basal cell and squamous cell skin
•cancers, and completely resected carcinoma in situ of any type.
•9. Patient has clinically significant, uncontrolled heart disease and/or recent cardiac event(within 6 months), such as:
•Unstable angina within 6 months prior to screening
•Myocardial infarction within 6 months prior to screening
•History of documented congestive heart failure (New York Heart Association functional classification III-IV)
•Uncontrolled hypertension defined by a Systolic Blood Pressure (SBP) greater than or equal to 160 mm Hg and/or Diastolic Blood Pressure (DBP) greater than or equal to 100 mm Hg, with or without antihypertensive medication. Initiation or adjustment of antihypertensive medication (s) is allowed prior to screening
•Ventricular arrhythmias
•Supraventricular and nodal arrhythmias not controlled with medication
•Other cardiac arrhythmia not controlled with medication
•Corrected QT (QTcF) greater than 470 ms using Fridericiaâ??s correction on the screening ECG
•(as mean of triplicate ECGs)
•10. Patient has impairment of GI function or GI disease that may significantly alter the
•absorption of LDK378 (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea,
•or malabsorption syndrome).
•11. Patient receiving treatment with medications that meet one of the following criteria and
•that cannot be d

研究者

发起方

ovartis Healthcare Pvt Ltd

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