2022-502467-38-00已完成2 期
ETOP 21-21 BOUNCE: A multicentre, randomised, phase II trial of brigatinib consolidation versus observation or durvalumab in patients with unresectable stage III NSCLC and ALK-rearrangement, after definitive chemo-radiotherapy.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 18
- 主要终点
- Progression-free survival, according to RECIST v1.1, evaluated in the ITT cohort. PFS will be compared between the two arms.
研究概览
简要总结
The primary objective of this trial is to evaluate the efficacy in terms of progression-free survival (PFS) for brigatinib consolidation compared to observation/durvalumab, in patients with unresectable stage III NSCLC and ALK-rearrangement, who completed definitive chemo-radiotherapy without disease progression. Secondary measures of clinical efficacy will be evaluated, including overall survival (OS), CNS-relapse-free survival, patterns of disease progression, and safety.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Follow-up beyond progression
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Most important inclusion criteria for enrolment: • Pathologically documented, treatment naïve unresectable stage III NSCLC • Documented ALK-fusion, tested locally on tumor tissue by a validated method (DNA NGS, RNA NGS, FISH, IHC, or ctDNA) • ECOG Performance Status 0-1 • Age ≥18 years • Patient is a candidate to receive chemo-radiotherapy, as per investigator’s assessment (including adequate haematological, renal and liver function as per local clinical practice). • Negative pregnancy test for women of childbearing potential. • Ability to comply with the trial protocol, in the investigator's judgment. • Written informed consent for trial participation must be signed and dated by the patient and the investigator prior to any trial-related intervention, including the submission of mandatory biomaterial. Most important inclusion criteria for randomisation: Randomisation of eligible patients must occur within 8 weeks after the last radiotherapy fraction. • Completion of thoracic radiotherapy • Non-PD at restaging • Adequate haematological, renal and liver function. • Negative pregnancy test for women of childbearing potential • No radiation pneumonitis of grade ≥2 • All other AEs from previous chemo-radiotherapy resolved to grade <2 (except for alopecia) • ECOG 0-2 • No major surgery, as defined by the investigator, within 4 weeks of the first planned dose of brigatinib. Minor surgical procedures such as catheter placement or minimally invasive biopsies are allowed. • No systemic treatment with strong cytochrome p-450 (cyp)3a inhibitors, strong cyp3a inducers, or moderate cyp3a inducers within 14 days before randomisation.
排除标准
- •Most important exclusion criteria for enrolment: • Diagnosis of another primary malignancy other than NSCLC. • Prior treatment for NSCLC • Any evidence of stage IV NSCLC • Significant, uncontrolled, or active cardiovascular disease - History of clinically significant atrial arrhythmia (including clinically significant brady-arrhythmia), as determined by the treating physician. - Any history of clinically significant ventricular arrhythmia. - Cerebrovascular accident or transient ischemic attack within 6 months before enrolment. - Myocardial infarction within 6 months before enrolment. - Unstable angina within 6 months before enrolment. - Congestive heart failure within 6 months before enrolment. • Uncontrolled hypertension: Patients with hypertension should be under treatment on study entry to control blood pressure. • History or the presence at baseline of pulmonary interstitial disease, drug-related pneumonitis. • Ongoing or active infection, including, but not limited to, the requirement for intravenous antibiotics. • Malabsorption syndrome or other GI illness that could affect oral absorption of brigatinib. • Known or suspected hypersensitivity to brigatinib or its excipients. • Any concurrent medical condition which, in the opinion of the investigator, would compromise patient safety or interfere with the evaluations of brigatinib.
结局指标
主要结局
Progression-free survival, according to RECIST v1.1, evaluated in the ITT cohort. PFS will be compared between the two arms.
Progression-free survival, according to RECIST v1.1, evaluated in the ITT cohort. PFS will be compared between the two arms.
次要结局
- Overall survival
- CNS-relapse-free survival
- Patterns of disease progression
- Toxicity according to CTCAE v5.0
研究者
ETOP IBCSG Partners Regulatory Office
Scientific
ETOP IBCSG Partners Foundation
研究点 (18)
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