JPRN-jRCT2031200231已完成1 期
Phase I/II study of Brigatinib plus Panitumumab in Patients with Advanced EGFR-mutated Non-small cell lung cancer harboring C797S resistant mutation to Osimertinib - BEBOP
Izumi Hiroki0 个研究点目标入组 65 人开始时间: 2020年12月4日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 65
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
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Histological or cytological diagnosis of NSCLC
- •2) Stage III/IV where radical resection and radical radiation therapy is impossible. Or postoperative recurrence.
- •3) Have a common EGFR activating mutation (i.e., exon 19 deletion or exon 21 L858R point mutation). (This requires the diagnosis based on a validated assay such as a genetic testing performed at a Clinical Laboratory Improvement Amendments [CLIA]-certified or quality-assured central laboratory.) Compound mutations not containing exon 20 insertion mutations will be acceptable.
- •4) Have confirmed disease progression after osimertinib therapy, for which no targeted therapy option is available. Patients who declined all other currently available treatment options after osimertinib may be enrolled. Patients can be treated with other chemotherapy after osimertinib failure.
- •5) Documented C797S resistance mutation-positive status after osimertinib failure in tissue or blood samples. (Either fresh or archival tissue sample is permitted.)
- •* In the Phase I part, the presence or absence of C797S will be disregarded.
- •* The presence or absence of EGFR activating mutations at the detection of C797S will be disregarded.
- •6) Have at least one measurable, non-irradiated lesion according to RECIST v1.1.
- •- In the Phase I part, the presence or absence of measurable lesions will be disregarded.
- •- A previously irradiated lesion may be regarded as a target lesion if an increase in size is observed and had a clear margin for assessment after completion of radiation therapy.
- •7) Males and females aged >= 20 years on the date of informed consent for study participation
- •8) An Eastern Cooperative Oncology Group (ECOG) PS score of 0-2
- •9) Have adequate organ function as defined by the following criteria:
- •- AST and ALT: =< 2.5 times the upper limit of normal (ULN) (<=5 times the ULN if liver function abnormalities are due to malignancy)
- •Total serum bilirubin:=< 1.5 times the ULN (<3.0xULN for patients with Gilbert syndrome).
- •- Absolute neutrophil count: >= 1,500/uL
- •- Platelet count: >= 100,000 /uL
- •- Hemoglobin: >=9.0 g/dL
- •- Serum creatinine: =< 2 times the ULN
- •- Serum lipase =<1.5xULN
- •10) Received an explanation with a document about the study and signed informed consent form before enrollment.
- •11) Capable of making scheduled visits and are willing to cooperate with study-related procedures including treatment and testing.
- •12) Patients meeting the following:
- •Female patients who:
- •- Are postmenopausal for at least 1 year before the screening visit, OR
- •- Are surgically sterile, OR
- •- If they are of childbearing potential, agree to practice 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 intercourse.
- •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.
排除标准
- •1) Currently participating and receiving treatment in another interventional clinical trial
- •2) Received any of the following within 2 weeks prior to enrollment: chemotherapy (if this included an immune checkpoint inhibitor, within 1 month prior to enrollment), radiotherapy (excluding palliative treatment), or major surgery within 30 days prior to enrollment. Patients who completed palliative radiotherapy including SRS or SBRT >=48 hours prior to enrollment are eligible.
- •3) Not recovered to grade 1 from acute toxicity (excluding alopecia) of prior treatment.
- •4) Symptomatic brain metastases. A patient, who is asymptomatic or receiving treatment, and neurologically stable at least for 2 weeks not requiring an increase in corticosteroid, is eligible for the study.
- •5) Spinal cord compression, carcinomatous meningitis, or leptomeningeal disease that do not have good pain control and have not maintained or restored neurologic function by treatment.
- •6) CT-confirmed or a history of pulmonary fibrosis or interstitial lung disease
- •7) Any of the following history/comorbidities within 6 months prior to the start of study treatment
- •- Myocardial infarction
- •- Severe or unstable angina
- •- Coronary or peripheral artery bypass graft
- •- Heart failure
- •- Cerebrovascular disorders including transient ischemic attack
- •- Uncontrolled hypertension
- •- Uncontrolled infection
- •- Malabsorption syndrome or other GI illness that could affect oral absorption of brigatinib
- •8) Progressive arrhythmia of grade >=2 according to NCI CTCAE v5.0, uncontrolled atrial fibrillation of any grade, and QTc > 470 msec.
- •9) 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
- •10) Use of drugs or food with CYP3A4 inhibiting activity at study enrollment
- •11) Use of drugs with CYP3A4 inducing activity at study enrollment
- •12) Use of drugs with strong CYP3A4 inhibiting activity at study enrollment, or use of drugs with strong or moderate CYP3A4 inducing activity within 14 days prior to enrollment
- •13) Use of other anticancer drugs (including Chinese herbal medicines)
- •14) Affected by active malignancy in the past 3 years (excluding NSCLC, early stage gastrointestinal cancer completely resected using endoscope (carcinoma in situ), non-melanoma skin cancer, localized cervical cancer, prostate cancer that is localized or estimated to be cured).
- •15) Other severe acute or chronic medical or psychiatric conditions, or laboratory abnormalities that would impart, in the judgment of the investigator or subinvestigator (hereinafter, investigators, etc.), risk associated with study participation or study drug administration, and which would, therefore, make the patient inappropriate for enrollment in this study.
- •16) Patients who are judged to be inappropriate for the study by the investigators, etc.
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