EUCTR2014-001237-83-ES进行中（未招募）1 期
A PHASE II, MULTICENTER, SINGLE-ARM STUDY OF TRASTUZUMAB EMTANSINE IN PATIENTS WITH HER2 IHC-POSITIVE, LOCALLY ADVANCED OR METASTATIC NON?SMALL CELL LUNG CANCER WHO HAVE RECEIVED AT LEAST ONE PRIOR CHEMOTHERAPY REGIME
Roche Farma, S.A en nombre de F. Hoffmann-La Roche Ltd0 个研究点目标入组 40 人开始时间: 2014年8月19日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
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
- •- Age >/= 18 years
- •- Histologically or cytologically documented diagnosis of Stage IIIB not amenable to radical treatment or Stage IV NSCLC; pathological characterization must determine the non-squamous or squamous histological subtype as well as adenocarcinoma subtype classification.
- •- HER2 status of IHC 2+ or 3+ as determined by a Sponsor-designated central laboratory
- •- Prior treatment with at least one regimen of platinum-based (cisplatin or carboplatin) chemotherapy in the locally advanced or metastatic setting/recurrent NSCLC with documented disease progression by investigator assessment
- •- Patients with a known ALK fusion oncogene (must be documented in the patient's chart) must have also experienced disease progression or intolerance with a first-line ALK Tyrosine Kinase Inhibitor (TKI) approved for the treatment of ALK fusion oncogene NSCLC (e.g., crizotinib). Disease progression or intolerance must be documented
- •- Patients with a known mutation in the EGFR gene (must be documented in the patient's chart) must have also experienced disease progression or intolerance with an EGFR TKI approved for the treatment of EGFR-mutant NSCLC (e.g., gefitinib, erlotinib, afatinib). Disease progression or intolerance must be documented.
- •- Measurable disease determined as per the Response Evaluation Criteria in Solid Tumors (RECIST) criteria, version 1.1
- •- Life expectancy >/= 12 weeks
- •- Adequate organ function
- •- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •- LVEF >/= 50% by either echocardiogram (ECHO) or or multiple-gated acquisition (MUGA)
- •- Use of highly effective 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 12
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 28
排除标准
- •Cancer-Related Criteria
- •- Any approved anti-cancer therapy 7 days prior to the first study treatment on Cycle 1, Day 1 (The baseline computed tomography scan must be completed after discontinuation of TKIs); (2) Hormone-replacement therapy or oral contraceptives; (3) Anti-emetics, GCS-F, prophylactic antibiotics are allowed according to local standards
- •- Investigational therapy participation in another clinical study with therapeutic intent - Previous irradiation is permitted if >/= 14 days since the last fraction of radiotherapy have elapsed before the first study treatment on Day 1 of Cycle 1 as long as a sufficient number of target lesions remain to allow for measurable disease as per RECIST v1.1.
- •- Patients who have untreated brain metastases or are symptomatic; patients with treated brain metastases must have discontinued corticosteroid therapy and not have any neurological symptoms
- •- History of intolerance (including Grade 3 or 4 infusion reaction) or hypersensitivity to trastuzumab or murine proteins or any excipient of the product
- •- History of exposure to the following cumulative doses of anthracyclines: Doxorubicin or liposomal doxorubicin > 500 mg/m2; Epirubicin > 900 mg/m2; Mitoxantrone > 120 mg/m2. If another anthracycline, or more than one anthracycline, has been used, the cumulative dose must not exceed the equivalent of 500 mg/m2 doxorubicin.
- •- Current peripheral neuropathy of Grade >/= 3 per the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) v. 4.0
- •- History of other malignancy within the last 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or other cancers with a similar outcome as those mentioned above.
- •Cardiopulmonary Function Criteria
- •- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
- •- Severe dyspnea at rest due to complications of advanced malignancy or requiring current continuous oxygen therapy
- •- Clinical history of active hemoptysis
- •- Evidence of active pneumonitis during screening
- •- Current unstable ventricular arrhythmia requiring treatment
- •- History of symptomatic congestive heart failure (CHF; New York Heart Association [NYHA] Classes II-IV)
- •- History of myocardial infarction or unstable angina within 6 months of enrollment
- •- History of a decrease in LVEF to < 50%
- •General Criteria
- •- Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease)
- •- Major surgical procedure or significant traumatic injury within 28 days before enrollment or anticipation of the need for major surgery during the course of study treatment
- •- Current pregnancy or lactation
- •- Current known active infection with HIV, hepatitis B, or hepatitis C virus
研究者
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