A Phase II Study of WX-0593 Combined With Concurrent Chemoradiotherapy in the Treatment of Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) With Activating Mutation of ALK or ROS1
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Percentage of Participants Who Develop Grade 3 or Higher drug-related Pneumonitis
研究概览
简要总结
The aim of this trial is to evaluate the safety of WX-0593 combined with concurrent chemoradiotherapy in unresectable, locally advanced non-small cell lung cancer (NSCLC) with activating mutation of ALK or ROS1. This trial consists of two parts. In Part 1, approximately 8 patients will be included and receive WX-0593 maintenance until disease progression or unacceptable toxicity. In Part 2, approximately 32 patients will be included and receive WX-0593 monotherapy for 1-2 cycles and subsequently with concurrent chemoradiation, followed by WX-0593 maintenance until disease progression or unacceptable toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Male or female aged 18 years or older;
- •Pathologically confirmed NSCLC who present with investigator-assessed previously untreated, unresectable, locally advanced (Stage II、III) disease (according to TMN staging of AJCC version 8);
- •Has active mutation of ALK or ROS1;
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1;
- •Has at least one evaluable lesion (according to RECIST 1.1);
- •Have adequate pulmonary function test as a forced expiratory volume in 1 second (FEV1) >50% of predicted normal volume and carbon monoxide lung diffusing capacity (DLCO) >40% of predicted normal value;
- •Have adequate organ and marrow function;
- •If participant is a woman of childbearing potential (WOCBP), must agree to follow the contraceptive guidance from written informed consent until at least 180 days after the last dose of study treatment. The female participant should have negative serum pregnancy test within 7 days prior to the first dose of study drug, and not breastfeeding;
- •A male participant must agree to use contraception from written informed consent until at least 180 days after the last dose of study treatment.
排除标准
- •Diagnosed other malignant tumor besides NSCLC within 5 years prior to study entry;
- •Mixed small cell and non-small cell lung cancer histology;
- •Has received prior therapy with any ALK TKI;
- •Has a history of extensive diffuse/bilateral interstitial fibrosis, or grade 3 or 4 pulmonary fibrosis or interstitial lung disease prior to the first dose of study drug.
- •Has a known history of active tuberculosis; severe infection within 4 weeks prior to study entry;
- •History of primary immunodeficiency;
- •Active or prior documented autoimmune disease within the past 2 years. NOTE: Patients with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded.
研究组 & 干预措施
WX-0593 single arm
Part 1: Participants will receive WX-0593 monotherapy until disease progression or unacceptable toxicity.
Part 2: Participants will receive 1 or 2 cycles of WX-0593 monotherapy and subsequently with concurrent chemoradiation, followed by WX-0593 monotherapy until disease progression or unacceptable toxicity.
干预措施: WX-0593 Tablets (Drug)
WX-0593 single arm
Part 1: Participants will receive WX-0593 monotherapy until disease progression or unacceptable toxicity.
Part 2: Participants will receive 1 or 2 cycles of WX-0593 monotherapy and subsequently with concurrent chemoradiation, followed by WX-0593 monotherapy until disease progression or unacceptable toxicity.
干预措施: chemotherapy (Drug)
WX-0593 single arm
Part 1: Participants will receive WX-0593 monotherapy until disease progression or unacceptable toxicity.
Part 2: Participants will receive 1 or 2 cycles of WX-0593 monotherapy and subsequently with concurrent chemoradiation, followed by WX-0593 monotherapy until disease progression or unacceptable toxicity.
干预措施: Thoracic Radiation Therapy（TRT） (Radiation)
结局指标
主要结局
Percentage of Participants Who Develop Grade 3 or Higher drug-related Pneumonitis
时间窗: within 90 days after radiation therapy
次要结局
- Progression Free Survival (PFS)(24 months)
- Overall Survival (OS)(24 months)
- Adverse Events (AEs)(24 months)
- Disease control rate (DCR)(24 months)
- Objective response rate (ORR)(24 months)
研究者
Jinming Yu
Director of the hospital
Shandong Cancer Hospital and Institute