NCT05168566招募中2 期
A Multicenter, Open-label, Phase IIb Study to Evaluate the Efficacy and Safety of Sutetinib Maleate Capsule in Locally Advanced or Metastatic NSCLC (Non-resistant Uncommon EGFR Mutations Only, Including L861Q, G719X, and/or S768I)
Teligene US33 个研究点 分布在 2 个国家目标入组 99 人开始时间: 2022年9月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 99
- 试验地点
- 33
- 主要终点
- Assessment of Objective response rate (ORR)
研究概览
简要总结
This is a Phase 2b, multicenter, open-label study to evaluate the safety and efficacy of Sutetinib Maleate Capsule in Locally Advanced or Metastatic NSCLC (Non-resistant Uncommon EGFR Mutations Only, Including L861Q, G719X, and/or S768I)
详细描述
Sutetinib is an investigational irreversible EGFR tyrosine kinase inhibitor. EGFR is a gene that makes a protein that is involved in cell growth and cell survival. Mutated (changed) forms of the EGFR gene and protein have been found in some types of cancer, including non-small cell lung cancer. These changes may cause cancer cells to grow and spread in the body. The purpose of this study is to explore how effective Sutetinib maleate capsules are for the treatment of patients with locally advanced or metastatic NSCLC with non-resistant uncommon EGFR mutations
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
- •Age 18 years old and above, male or female.
- •Histopathological and/or cytopathological confirmation of locally advanced or metastatic NSCLC patients with ≤ 1 prior line of chemotherapy.
- •Confirmation that the tumor harbors a non-resistant uncommon EGFR mutation (tumor tissue biopsy), including one or more of L861Q, G719X and S768I mutations, excluding any other EGFR sensitive mutations and/or oncogenes..
- •At least one measurable lesion.
- •ECOG score of 0, 1, or
- •A minimum life expectancy of > 3 months.
- •Adequate bone marrow reserve, hepatic, renal and coagulation function.
- •Willingness of all subjects of childbearing potential to use acceptable methods of birth control.
排除标准
- •Ever used the epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) for anti-tumor therapy prior to enrollment.
- •Any systemic anti-tumor therapy such as chemotherapy, immunotherapy and radiation therapy used within 4 weeks prior to enrollment; any palliative radiotherapy for non-target lesions used to relieve symptoms and traditional Chinese medicines indicated for tumor within 2 weeks prior to enrollment.
- •Use or intake of drugs or foods containing potent inhibitor or inducer of cytochrome P450 isozyme 3A4 (CYP3A4) within 14 days or 5 half-lives, whichever was the longer, prior to enrollment.
- •Surgical operation (excluding aspiration biopsy) of main organs or a significant injury within 4 weeks prior to enrollment.
- •Any unresolved toxicities from prior therapy greater than Grade 1 at the time of screening except alopecia.
- •Inability to swallow the study medication, any seriously chronic gastrointestinal disorder, malabsorption syndrome or any other conditions with influence on gastrointestinal absorption.
- •Active central nervous system metastases
- •Previous or current interstitial lung disease, radiation pneumonitis which requires hormone therapy, or drug-related pneumonia, idiopathic interstitial pulmonary fibrosis identified in a baseline CT scan; uncontrolled massive pleural or pericardial effusion.
- •Any active infection which has not been controlled at screening.
- •Any serious cardiovascular disease.
- •History of other serious systemic disease not suitable for clinical trial.
- •Participation in other interventional clinical trial 4 weeks prior to enrollment or within 5 half-lives from the last dose of investigational product (whichever is longer).
- •Known alcohol or drug dependence.
- •Mental disorders or poor compliance.
- •Previously received solid organ transplantation or hematopoietic stem cell transplantation.
- •Females who are pregnant or breastfeeding.
- •Known hypersensitivity to the active ingredients or excipients of the investigational product.
- •Have any other primary malignant tumors within 3 years (except some low- risk cancers).
研究组 & 干预措施
Sutetinib Maleate Arm
Experimental
Sutetinib capsules monotherapy
干预措施: Sutetinib Maleate Capsule (Drug)
结局指标
主要结局
Assessment of Objective response rate (ORR)
时间窗: 2 Years
Objective response rate (ORR) assessed by IRC
次要结局
- Assessment of Overall survival (OS)(2 Years)
- Assessment of Time to treatment failure (TTF)(2 Years)
- Assessment of Disease control rate (DCR)(2 Years)
- Assessment of Duration of response (DoR)(2 Years)
- Assessment of Time to progressive disease(2 Years)
- Assessment of Time to response(2 Years)
- Assessment of Progression free survival (PFS)(2 Years)
- Assessment of 1-year progression-free survival(1 Year)
- Assessment of Peak Plasma Concentration (Cmax) or Area under the plasma concentration versus time curve (AUC)(2 Years)
- Assessment of 1-year survival(1 Years)
- Assess incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).(2 Years)
研究者
研究点 (33)
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