KCT0004234招募中未知
Brigatinib in ALK-positive NSCLC identified via Blood-based Assays
ational Cancer Center0 个研究点目标入组 35 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 35
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 18(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1. The participant(or legally acceptable representative if
- •applicable) provides written informed consent for the study 2. Patients who have
- •disease progression with prior one ALK-TKI treatment for inoperable Stage III
- •(locally advanced) or metastatic ALK+ NSCLC.(Previous treatment only allowed one
- •ALK-inhibitor) Patients who have received prior neo-adjuvant, adjuvant
- •chemotherapy, radiotherapy, or chemoradiotherapy with curative intent for
- •non-metastatic disease must have experienced a treatment-free interval of at
- •least 6 months since the last chemotherapy, radiotherapy, or chemoradiotherapy
- •cycle. 3. ALK rearrangement , as detected via the blood somatic mutation assay
- •4. One prior ALK inhibitor therapy 5. Have at least 1 measurable lesion per
- •RECIST version 1.1 6. Have Eastern Cooperative Oncology Group (ECOG) performance
- •status 0-2 7. Recovered from toxicities related to prior anticancer therapy to
- •NCI CTCAE, version 5.0, Grade=1(Note : Alopecia, sensory neuropathy Grade=2, or
- •other Grade=2 AEs not constituting a safety risk based on Investigator’s
- •judgement are acceptable 8. Have a life expectancy of =3 months 9. Have adequate
- •organ and hematologic function as determined by: a) ALT/AST=2.5×ULN; =5×ULN is
- •acceptable if liver metastases are present b) Total serum bilirubin=1.5×ULN
- •(<3.0×ULN for patients with Gilbert syndrome) c) Estimated glomerular
- •filtration rate (eGFR) =30 mL/min/1.73 m2, using the MDRD equation d) Absolute
- •neutrophil count =1.5×109/L. e) Platelet count =75×109/L. f) Hemoglobin =9 g/dL.
- •g) Serum lipase =1.5×ULN 10. For female patients of childbearing potential,
- •have a negative pregnancy test(urine or serum) documented =3 days before start
- •of study medication. non-childbearing potential which is defined as : - female
- •patient=45 years of age and has not had menses for greater than 1 year - a
- •female who is status post hysterectomy, oophorectomy 11. Female patients of
- •childbearing potential and male patients with partners of childbearing potential
- •must agree to use 2 effective methods of contraception, at the same time, from
- •the time of signing the informed consent through 4 months after the last dose of
- •study drug, or agree to completely abstain from heterosexual intercourseHave the
- •willingness and ability to comply with scheduled visit and study procedures.
- •Male patients, even if surgically sterilized (i.e., status post-vasectomy),
- •who: • Agree to practice effective barrier contraception during the entire study
- •treatment period and through 4 months after the last dose of study drug, or
- •Agree to completely abstain from heterosexual intercourse 12. Have the
- •willingness and ability to comply with scheduled visit and study procedures.
- •13. Be = 18 years of age
排除标准
- •1. Has received ALK-targeted TKI within 7 days before the
- •first dose of study treatment(If clinically justified, 3 days wash-out period
- •could be allowed). 2. Has received radiotherapy within 14 days before the first
- •dose of study treatment except for stereotactic radiosurgery (SRS) or
- •stereotactic body radiation therapy (SBRT). A 1-week washout is permitted for
- •palliative radiation(=2 weeks of radiotherapy) to non-CNS disease. 3. Had major
- •surgery within 28 days of the first dose of study treatment. Minor surgical
- •procedures are allowed. 4. Has symptomatic brain metastasis or leptomeningeal
- •disease. Prior brain metastasis or leptomeningeal disease allowed if
- •asymptomatic or stable symptoms that did not require an increased dose of
- •corticosteroids to control symptoms within 7 days prior to study enrollment. If
- •patients have neurological symptoms or signs due to CNS metastasis, patients
- •need to complete whole brain radiation or stereotactic radiosurgery treatment
- •before enrollment and be clinically stable. 5. Has current spinal cord
- •compression 6. Other malignancy within 3 years, except for adequately treated
- •carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized
- •prostate cancer treated surgically with curative intent, and ductal carcinoma in
- •situ treated surgically with curative intent 7. Any gastrointestinal (GI)
- •disorder that may affect absorption of oral medications, such as malabsorption
- •syndrome or status post-major bowel resection 8. Have significant, uncontrolled,
- •or active cardiovascular disease, specifically including, but not restricted to:
- •a) Myocardial infarction within 6 months before the first dose of brigatinib.
- •b) Unstable angina within 6 months before first dose of brigatinib. c)
- •Congestive heart failure within 6 months before first dose of brigatinib. d)
- •History of clinically significant atrial arrhythmia (including clinically
- •significant bradyarrhythmia). e) Any history of clinically significant
- •ventricular arrhythmia. 9. Has uncontrolled hypertension. 10. Had a
- •cerebrovascular accident or transient ischemic attack within 6 months before
- •first dose brigatinib. 11. Have a history or the presence of pulmonary
- •interstitial disease, drug-related pneumonitis, or radiation-related pneumonitis
- •12. Active infection requiring systemic therapy. 13. Known history of HIV
- •infection. 14. Has a known or suspected hypersensitivity to brigatinib or its
- •excipients. 15. Female patients who are both lactating and breastfeeding or have
- •a positive serum pregnancy test during the screening period or a positive urine
- •pregnancy test on Day 1 before first dose of study drug (if applicable).
- •16. Have any condition or illness that, in the opinion of the investigator,
- •would compromise 17. patient safety or interfere with the evaluation of
- •brigatinib 18. Received systemic treatment with strong cytochrome P-450 (CYP)3A
- •inhibitors, strong CYP3A inducers, or moderate CYP3A inducers within 14 days
- •before enrollment.
研究者
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