NCT04009317Unknown3 期
A Multicenter, Randomized, Open-label Study to Evaluate the Efficacy and Safety of TQ-B3139 Versus Crizotinib in the First Line Treatment of Subjects With Anaplastic Lymphoma Kinase (ALK) Positive Non-Small Cell Lung Cancer (NSCLC)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
To evaluate the efficacy and safety of TQ-B3139 versus crizotinib in subjects with ALK-positive NSCLC that have received one chemotherapy regimen and have not received ALK inhibitor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.18 and 75 years.
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to
- •Life expectancy ≥12 weeks.
- •Histologically or cytologically confirmed advanced or metastatic NSCLC with ALK-positive.
- •Has not received ALK tyrosine kinase inhibitor (TKI).
- •Has received one chemotherapy regimen for stage IIIB-IV NSCLC.
- •At least one measurable lesion.
- •Adequate organ system function.
- •Understood and signed an informed consent form.
排除标准
- •Has diagnosed and/or treated additional malignancy within 5 years prior to randomization. Exceptions include cured cancer carcinoma in situ of the cervix, intramucosal carcinoma of gastrointestinal tract, breast and melanoma skin cancers and superficial bladder tumors.
- •Hypersensitivity to TQ-B3139 or crizotinib.
- •Has received any cancer therapy within 4 weeks or 5 times of t1/
- •Has received any major surgery within 4 weeks.
- •Has received any radiotherapy or minor surgery aimed to cure cancer within 2 weeks.
- •Acute toxicity that is ≥ Grade 2 caused by previous cancer therapy.
- •Has active viral, bacterial and fungal infections within 2 weeks before the first dose.
- •Has serious cardiovascular disease within 3 months before the first dose.
- •Has currently uncontrollable congestive heart failure.
- •Has continuous arrhythmia ≥ Grade 2, uncontrollable atrial fibrillation or QTc interval > 480ms.
- •Has interstitial fibrosis or interstitial lung disease ≥ Grade
- •Brain metastases with symptom.
- •HBsAg positive and HBV DNA positive (≥ULN);HCV antibody and HCV-RNA positive (≥ULN); HIV positive or ≥HIV ULN.
- •Has multiple factors affecting oral medication.
- •Has received a strong CYP3A inhibitors within 7days before the first dose.
- •Has received a strong CYP3A inducers.
- •Breastfeeding or pregnant women.; Men unwilling to use adequate contraceptive measures during the study.
- •According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
研究组 & 干预措施
TQ-B3139
Experimental
TQ-B3139 tablet 600mg administered orally , twice daily in 28-day cycle.
干预措施: TQ-B3139 (Drug)
Crizotinib
Active Comparator
Crizotinib tablet 250mg administered orally, twice daily in 28-day cycle.
干预措施: Crizotinib (Drug)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: up to 36 months
PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.
次要结局
- Disease Control rate (DCR)(up to 36 months)
- Objective Response Rate (ORR)(up to 36 months)
- Overall Survival (OS)(up to 36 months)
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
2 期
Study of TQ-B3139 in Subjects With Anaplastic Lymphoma Kinase (ALK) Positive Non-Small Cell Lung Cancer (NSCLC) Previously Treated With CrizotinibALK-positive NSCLCNCT04056572Chia Tai Tianqing Pharmaceutical Group Co., Ltd.135
Unknown
不适用
Crizotinib in ALK Rearranged Non-small-cell Lung CancerNon Small Cell Lung CancerAdvanced CancerMetastatic CancerNCT04317651Fondazione Ricerca Traslazionale500
已完成
3 期
ALTA-1L Study: A Study of Brigatinib Versus Crizotinib in Anaplastic Lymphoma Kinase Positive (ALK+) Advanced Non-small Cell Lung Cancer (NSCLC) ParticipantsAdvanced MalignanciesCarcinomaLung CancerNon-small Cell Lung CancerNCT02737501Ariad Pharmaceuticals275
进行中（未招募）
3 期
A Study of Zanubrutinib Plus Anti-CD20 Versus Lenalidomide Plus Rituximab in Participants With Relapsed/Refractory Follicular or Marginal Zone LymphomaRelapsed/Refractory Follicular LymphomaMarginal Zone LymphomaNCT05100862BeOne Medicines799
招募中
1 期
Lenvatinib Plus Tislelizumab With or Without TACE in First-line Treatment of Unresectable HCCHepatocellular CarcinomaNCT05842317Peking Union Medical College Hospital60