EUCTR2016-003315-35-IT进行中（未招募）1 期
A Phase 3, randomized, open-label study of lorlatinib (PF-06463922) monotherapy versus crizotinib monotherapy in the first-line treatment of patients with advanced ALK-positive non-small cell lung cancer - Study with investigational drug PF-06463922 and comparator crizotinib in patients with a specific ty
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- PFIZER INC
- 入组人数
- 280
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Diagnosis:
- •a. Study Population: Patients with histologically or cytologically confirmed diagnosis of locally advanced (Stage IIIB not amenable for multimodality
- •treatment) or metastatic (Stage IV) ALK-positive NSCLC where ALK status is determined by the FDA-approved (for use in US), CE (Conformité Européene)
- •marked (for EU and other countries that accept CE marking), and PMDA(Pharmaceuticals and Medical Devices Agency)-approved (for use in
- •Japan) Ventana ALK (D5F3) Companion Diagnostic (CDx) IHC test performed on the Ventana ULTRA or XT platforms (refer to Section 6.1.1.1 for any prescreening activity related to ALK determination);
- •b. Tumor Requirements: At least 1 extracranial measurable target lesion per RECIST v. 1.1 that has not been previously irradiated. CNS metastases are
- •allowed if asymptomatic and:
- •i. Either untreated and not currently requiring corticosteroid treatment, or on a stable or decreasing dose of =10 mg QD prednisone or equivalent; or
- •ii. Local treatment has been completed with full recovery from the acute effects of radiation therapy or surgery prior to randomization, and if corticosteroid
- •treatment for these metastases has been withdrawn for at least 4 weeks with neurological stability; or
- •iii. In case of leptomeningeal disease (LMD) or carcinomatous meningitis (CM) if visualized on magnetic resonance imaging (MRI) , or if baseline CSF
- •positive cytology is available.
- •c. Tissue Requirements: All patients must have an archival formalin fixed, paraffin embedded (FFPE) tissue specimen available and collected prior to randomization.
- •If archived tissue is unavailable, then a mandatory de novo biopsy must be performed.
- •2. No prior systemic NSCLC treatment for advanced (Stage IIIB not amenable for multimodality treatment) or metastatic (Stage IV) disease, including molecularly
- •targeted agents (eg, ALK TKIs), angiogenesis inhibitors, immunotherapy, or chemotherapy. Prior treatment for earlier Stages of the NSCLC only allowed if
- •completed more than 12 months prior to randomization.
- •3. Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0, 1, or 2.
- •4. Age =18 years (or =20 years as required by local regulation).
- •5. Adequate Bone Marrow Function, including:
- •a. Absolute Neutrophil Count (ANC) = 1,500/mm3 or =1.5 x 109/L;
- •b. Platelets =100,000/mm3 or =100 x 109/L;
- •c. Hemoglobin =9 g/dL.
- •6. Adequate Pancreatic Function, including:
- •a. Serum total amylase =1.5 x upper limit of normal (ULN)*;
- •b. Serum lipase =1.5 x ULN.
- •*if total amylase >1.5 x ULN, but pancreatic amylase is within the ULN, then patient may be
- •7. Adequate Renal Function, including:
- •a. Serum creatinine =1.5 x ULN or estimated creatinine clearance =60 mL/min as calculated using the method standard for the institution.
- •8. Adequate Liver Function, including:
- •a. Total serum bilirubin =1.5 x ULN;
- •b. Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) =2.5 x ULN (=5.0 x ULN in case of liver metastases).
- •9. Acute effects of prior radiotherapy resolved to baseline severity or to CTCAE Grade =1 except for AEs that in the investigator’s judgment do not constitute a safety risk
- •for the patient.
- •10. Serum pregnancy test (for females of childbearing potential) negative at screening. Female patients of non-childbearing potential must meet at least 1 of the following
- •- Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or
- •physiological
排除标准
- •1. Spinal cord compression unless the patient has good pain control attained through therapy, and there is stabilization or recovery of neurological function for the 4 weeks
- •prior to randomization.
- •2. Major surgery within 4 weeks prior to randomization. Minor surgical procedures (eg, port insertion) are not excluded, but sufficient time should have passed for adequate
- •wound healing.
- •3. Radiation therapy within 2 weeks prior to randomization, including stereotactic or partial brain irradiation. Patients who complete whole brain irradiation within
- •4 weeks prior to randomization or palliative radiation therapy outside of the CNS within 48 hours prior to randomization will also not be included in the study.
- •4. Gastrointestinal abnormalities, including inability to take oral medication; requirement for intravenous alimentation; prior surgical procedures affecting
- •absorption including total gastric resection or lap band; active inflammatory gastrointestinal disease, chronic diarrhea, symptomatic diverticular disease; treatment
- •for active peptic ulcer disease in the past 6 months; malabsorption syndromes.
- •5. Known prior or suspected severe hypersensitivity to study drugs or any component in their formulations.
- •6. Active and clinically significant bacterial, fungal, or viral infection including hepatitis B virus (HBV) or hepatitis C virus (HCV) (eg, in case of known HBsAg or HCV
- •antibody positivity), known human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS)-related illness.
- •7. Clinically significant vascular (both arterial and venous) and non-vascular cardiac conditions, (active or within 3 months prior to enrollment), which may include, but
- •are not limited to:
- •¿ Arterial disease such as cerebral vascular accident/stroke (including Transient Ischemic Attack -TIA), myocardial infarction, unstable angina;
- •¿ Venous diseases such as cerebral venus thrombosis, symptomatic pulmonary embolism;
- •¿ Non-vascular cardiac disease such as congestive heart failure (New York Heart Association Classification Class = II), second-degree or third-degree AV block
- •(unless paced) or any AV block with PR >220 msec; or ongoing cardiac dysrhythmias of NCI CTCAE Grade =2, uncontrolled atrial fibrillation of any
- •grade, bradycardia defined as <50 bpm (unless patient is otherwise healthy such as long-distance runners, etc.), machine-read Electrocardiogram (ECG) with QTc
- •>470 msec, or congenital long QT syndrome.
- •8. Patients with predisposing characteristics for acute pancreatitis according to investigator judgment (eg, uncontrolled hyperglycemia, current gallstone disease) in
- •the last month prior to randomization.
- •9. History of extensive, disseminated, bilateral or presence of Grade 3 or 4 interstitial fibrosis or interstitial lung disease including a history of pneumonitis, hypersensitivity
- •pneumonitis, interstitial pneumonia, interstitial lung disease, obliterative bronchiolitis, and pulmonary fibrosis.
- •10. Evidence of active malignancy (other than NSCLC, non-melanoma skin cancer, or localized prostate cancer or any in situ cancer which does not currently require
- •treatment) within the last 3 years prior to randomization.
- •Please refer to the protocol for complete list of exclision citeria.
研究者
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