NCT07754123尚未招募3 期
A Randomized, Controlled, Open-Label, Multicenter Phase III Study to Evaluate the Efficacy and Safety of HS-10504 Versus Platinum-Based Doublet Chemotherapy in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Harboring EGFR C797S Mutation After Failure of Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI) Therapy
Jiangsu Hansoh Pharmaceutical Co., Ltd.0 个研究点目标入组 206 人开始时间: 2026年9月17日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 206
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
This is a randomized, controlled, open-label, multicenter Phase III clinical study designed to evaluate the efficacy and safety of oral HS-10504 monotherapy versus platinum-based doublet chemotherapy in participants with locally advanced or metastatic NSCLC harboring EGFR C797S mutation after failure of EGFR TKI therapy.
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
- Single (Outcomes Assessor)
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.
- •Histologically or cytologically confirmed locally advanced or metastatic NSCLC (Stage IIIB, IIIC, or IV).
- •Documented failure after ≥1 prior line of EGFR TKI therapy with concurrent C797S mutation.
- •At least one measurable target lesion per RECIST v1.1 criteria.
排除标准
- •Presence of other well-documented driver gene mutations (e.g., ALK fusion, ROS1 fusion, KRAS activating mutations, MET exon 14 skipping, HER2 mutations, RET fusion).
- •Histological or phenotypic transformation (e.g., NSCLC to SCLC transformation, epithelial-to-mesenchymal transition) confirmed by tumor tissue obtained within 6 months prior to first dose.
- •≥ Grade 2 toxicities (per CTCAE v6.0) attributed to prior anti-tumor therapy (excluding alopecia and stable neurotoxicity).
- •History of other primary malignancies.
- •Inadequate bone marrow reserve or hepatic/renal organ function.
- •Clinically significant cardiac abnormalities or severe/uncontrolled/active cardiovascular disease.
- •Poorly controlled diabetes mellitus or hypertension.
- •Significant clinical bleeding tendency or history of severe arterial/venous thromboembolic events.
- •Severe or uncontrolled active infection.
- •Continuous systemic corticosteroid therapy (>30 days) within 30 days prior to first dose, or requirement for long-term (≥30 days) corticosteroid use.
- •Active infectious diseases (e.g., active hepatitis B virus [HBV] infection).
- •Clinically significant gastrointestinal disorders.
- •Hepatic encephalopathy, hepatorenal syndrome, or cirrhosis ≥ Child-Pugh class B.
- •Other pulmonary diseases that may interfere with assessment or management of drug-related pneumotoxicity.
- •History of severe neurological or psychiatric disorders.
研究组 & 干预措施
Platinum-Based Doublet Chemotherapy Group
Active Comparator
干预措施: platinum-based doublet chemotherapy (Pemetrexed and Cisplatin/Carboplatin) (Drug)
HS-10504 group
Experimental
干预措施: HS-10504 (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: From baseline, then every 6 weeks, until disease progression or discontinuation from study. From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.
Progression Free Survival (PFS) as assessed by Blinded independent Central Review (BICR) per RECIST 1.1
次要结局
- Overall Survival (OS)(Start of study drug to Survival Endpoint through study completion, an average of 3 years.)
- PFS(From baseline, then every 6 weeks, until disease progression or discontinuation from study. From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.)
- ORR(From baseline, then every 6 weeks, until disease progression or discontinuation from study. From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.)
- DoR(From baseline, then every 6 weeks, until disease progression or discontinuation from study. From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.)
- DCR(From baseline, then every 6 weeks, until disease progression or discontinuation from study. From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.)
- AE(From baseline, then every 6 weeks, until disease progression or discontinuation from study. From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.)
- SAE(From baseline, then every 6 weeks, until disease progression or discontinuation from study. From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.)
研究者
相似试验
尚未招募
3 期
SYS6002 vs Chemotherapy in Patients With Locally Advanced or Metastatic Urothelial CarcinomaUrothelial CarcinomaNCT07526792CSPC Megalith Biopharmaceutical Co.,Ltd.406
尚未招募
3 期
SYS6010 vs Investigator's Choice of Monotherapy in Patients With Recurrent or Metastatic HNSCCHead and Neck Squamous Cell CarcinomaNCT07758621CSPC Megalith Biopharmaceutical Co.,Ltd.340
尚未招募
3 期
A Phase III Study of KN026 in Combination With HB1801 as Adjuvant Therapy for Resectable HER2-Positive Breast CancerNCT07441460Shanghai JMT-Bio Inc.1,800
招募中
3 期
A Phase III Study Comparing HRS-4357 With Novel Androgen Receptor Pathway Inhibitors in Patients With Progressive, PSMA-Positive Metastatic Castration-Resistant Prostate CancerNCT07311694Jiangsu HengRui Medicine Co., Ltd.370
尚未招募
3 期
A Study of SYS6043 in Platinum-Resistant, Advanced Ovarian, Primary Peritoneal, or Fallopian Tube CancersPlatinum-resistant Ovarian CancerPlatinum-resistant Primary Peritoneal CancerPlatinum-resistant Fallopian Tube CancerNCT07708753CSPC Megalith Biopharmaceutical Co.,Ltd.460