NCT07822542尚未招募3 期
A Randomized, Open-label, Controlled, Multicenter Phase 3 Trial of HS-10370 Plus Platinum-based Doublet Chemotherapy With or Without Adebrelimab vs. Tislelizumab Plus Chemotherapy as First-Line Therapy in Patients With Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation.
Jiangsu Hansoh Pharmaceutical Co., Ltd.0 个研究点目标入组 448 人开始时间: 2026年10月31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
- 448
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
This is a trial to evaluate the efficacy, safety, and tolerability of HS-10370 in combination with Platinum-based Doublet Chemotherapy With or Without Adebrelimab Versus Tislelizumab Plus Platinum-based Doublet Chemotherapy as first-line treatment in participants with previously untreated, locally advanced or metastatic NSCLC with KRAS G12C mutation
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
- •Participants are able to comply with the process of the protocol.
- •Men or women greater than or equal to 18 years
- •At least one measurable lesion in accordance with RECIST 1.1
- •Must have an ECOG performance status of 0 or
- •Must have adequate laboratory parameters.
- •Patients with advanced solid tumors who have failed after adequate standard treatment, are intolerant to standard treatment, or have no standard treatment available.
- •Documentation of the presence of a KRAS G12C mutation
- •Reproductive-age women agree to use adequate contraception and cannot breastfeed while participating in this study and for a period of 6 months after the last dose.Men also consent to use adequate contraceptive method within the same time limit.
排除标准
- •Participants with tumors known to harbor molecular alterations for which targeted therapy is locally approved, except for KRAS G12C.
- •Treatment with any of the following: Previous or current treatment with other KRAS G12C inhibitors.
- •Active brain metastases.
- •Participants with uncontrolled pleural, ascites or pericardial effusion
- •History of other primary malignancies.
- •Abnormal cardiac examination results.
- •Severe, uncontrolled or active cardiovascular disorders.
- •Uncontrolled hypertension.
- •Severe bleeding symptoms or bleeding tendencies.
- •Severe arteriovenous thrombosis occurred
- •Serious infection.
- •Continuous use of glucocorticoids
- •Active infectious diseases.
- •Refractory nausea, vomiting, or chronic gastrointestinal diseases, or inability to swallow oral medications
- •Interstitial lung disease (ILD).
- •Serious neurological or mental disorders.
- •Active autoimmune diseases.
研究组 & 干预措施
Arm A: HS-10370 plus Adebrelimab plus chemotherapy
Experimental
干预措施: Carboplatin (Drug)
Arm C: HS-10370 plus chemotherapy
Other
干预措施: HS-10370 (Drug)
Arm B: Tislelizumab plus chemotherapy
Active Comparator
干预措施: Tislelizumab (Drug)
Arm A: HS-10370 plus Adebrelimab plus chemotherapy
Experimental
干预措施: Pemetrexed (Drug)
Arm B: Tislelizumab plus chemotherapy
Active Comparator
干预措施: Cisplatin (Drug)
Arm B: Tislelizumab plus chemotherapy
Active Comparator
干预措施: Pemetrexed (Drug)
Arm C: HS-10370 plus chemotherapy
Other
干预措施: Cisplatin (Drug)
Arm B: Tislelizumab plus chemotherapy
Active Comparator
干预措施: Carboplatin (Drug)
Arm C: HS-10370 plus chemotherapy
Other
干预措施: Carboplatin (Drug)
Arm A: HS-10370 plus Adebrelimab plus chemotherapy
Experimental
干预措施: Cisplatin (Drug)
Arm A: HS-10370 plus Adebrelimab plus chemotherapy
Experimental
干预措施: HS-10370 (Drug)
Arm A: HS-10370 plus Adebrelimab plus chemotherapy
Experimental
干预措施: Adebrelimab (Drug)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: Randomization to first documented progression of disease or death from any cause. (Estimated as approximately 1 year)
Progression-Free Survival (PFS) PFS per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by blinded independent central review (BICR)
次要结局
- Progression-Free Survival (PFS)(Randomization to first documented progression of disease or death from any cause. (Estimated as approximately 1 year))
- Overall Survival (OS)(Randomization to date of death from any cause. (Estimated as up to 3 years))
- Overall Response Rate (ORR)(Randomization to disease progression or death. (Estimated as approximately 1 year))
- Duration of Response (DOR)(Randomization to disease progression or death. (Estimated as approximately 1 year))
- Number of Participants with a Treatment Emergent Adverse Event(s) (TEAE)(Randomization to first documented progression of disease or death from any cause. (Estimated as approximately 1 year))
研究者
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