A Randomized, Open-Label, Multicenter, Phase 3 Study Evaluating the Efficacy and Safety of JYP0322 Versus Platinum-Based Chemotherapy in ROS1-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer Patients Previously Treated With ROS1-TKI Therapy.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 207
- 主要终点
- Progression Free Survival (PFS) by BICR Assessment
研究概览
简要总结
The primary purpose of the study was to compare progression-free survival of JYP0322 vs. platinum-based doublet chemotherapy in patients previously treated with ROS1-TKIs. Patients in the chemotherapy arm are given the option to switch to JYP0322 after BICR confirmed progressive disease (PD), while also have the choice to pursue with other drugs after discussing with their physicians.
详细描述
This is a phase III, open label, randomized study assessing JYP0322 (150 mg, orally, tid) versus platinum-based doublet chemotherapy in subjects with confirmed diagnosis of ROS1 fusion positive NSCLC, who have progressed following prior therapy with one or two approved ROS1 Tyrosine Kinase Inhibitor (ROS1-TKI) agents and whose tumors harbors a ROS1 fusion positive. Subjects must agree to provide a biopsy for central confirmation of ROS1 fusion status. A total of 207 patients will be randomly assigned in a 2:1 ratio to receive oral JYP0322 (at a dose of 150mg tid) or intravenous pemetrexed (500 mg per square meter of body-surface area) plus carboplatin (target area under the curve 5 [AUC5]) every 3 weeks for up to six cycles. Patients without disease progression after four cycles of platinu
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Key Inclusion Criteria
- •Subjects with histologically or cytologically documented NSCLC.
- •Locally advanced or metastatic ROS1 fusion positive NSCLC.
- •Prior one or two ROS1-TKI(s) Treatment.
- •World Health Organization (WHO) performance status 0-
- •Life expectancy of at least 3 months.
- •At least one measurable lesion according to RECISIT 1.1.
排除标准
- •Key Exclusion Criteria:
- •Current participation in another therapeutic clinical trial.
- •Gastrointestinal disease (e.g., Crohn's disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would impact on drug absorption.
- •A history of severe allergies, or a history of severe allergy, hypersensitivity or other hypersensitivity to any active or inactive ingredient of the study drug.
- •All acute toxic effects (excluding alopecia) of any prior anti-cancer therapy to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0 Grade more than
- •Any investigational agents or other anticancer drugs from a previous treatment regimen or clinical study within 14 days of the first dose of study treatment.
- •Known active infe
研究组 & 干预措施
JYP0322 tablets
干预措施: JYP0322 tablets (Drug)
Pemetrexed Disodium
干预措施: Pemetrexed injection (Drug)
Pemetrexed Disodium
干预措施: Cross-over to JYP0322 (Drug)
结局指标
主要结局
Progression Free Survival (PFS) by BICR Assessment
时间窗: UP to 3 years
Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Progressive Disease (PD): \>= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of \>=5mm (compared to the previous minimum sum) or progression of NTLs or a new lesion. PFS is the time from date of randomization until the date of PD (by BICR assessment) or death (due to any cause) regardless of whether the patient withdrew from randomized therapy. Patients who had not progressed or died at the time of analysis were censored at the time of the latest date of assessment from their last evaluable RECIST 1.1 assessment.
次要结局
- Progression Free Survival (PFS) by investigators Assessment(UP to 3 years)
- Overall Survival (OS)(UP to 5 years)
- Objective Response Rate (ORR) by Investigator and BICR assessment(RECIST tumor assessments every 6 weeks from randomization up to 3 years.)
- Duration of Response (DOR) by Investigator and BICR assessment(RECIST tumor assessments every 6 weeks from randomization up to 3 years.)
- Disease Control Rate (DCR) by Investigator and BICR assessment(RECIST tumor assessments every 6 weeks from randomization up to 3 years.)
- Time to Response (TTR) by Investigator and BICR assessment(RECIST tumor assessments every 6 weeks from randomization up to 3 years.)