NCT05920356招募中3 期
A Phase 3, Multicenter, Randomized, Open-label Study Evaluating Efficacy of Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Subjects With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers, Negative for PD-L1, and Positive for KRAS p.G12C (CodeBreaK 202)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Amgen
- 入组人数
- 750
- 试验地点
- 420
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
The primary objectives are to compare progression-free survival (PFS) and overall survival (OS) in participants who receive sotorasib with platinum doublet chemotherapy versus participants who receive pembrolizumab with platinum doublet chemotherapy.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed diagnosis of nonsquamous stage IV or advanced Stage IIIB or IIIC NSCLC with KRAS p. G12C mutation and negative for PD-L1 expression by central testing or local laboratory testing confirmed through central testing
- •No history of systemic anticancer therapy in metastatic/non-curable settings
- •Eastern Cooperative Oncology Group (ECOG) ≤ 1
排除标准
- •Mixed histology NSCLC with either small-cell or large-cell neuroendocrine cell component or predominant squamous cell histology
- •Participants with tumors known to harbor molecular alterations for which targeted therapy is locally approved as a front-line therapy
- •Symptomatic (treated or untreated) brain metastases
- •Gastrointestinal (GI) tract disease causing the inability to take oral medication
- •Myocardial infarction within 6 months of randomization, unstable arrhythmias, or unstable angina
- •Prior therapy with a KRAS G12C inhibitor
研究组 & 干预措施
Pembrolizumab combined with carboplatin and pemetrexed
Active Comparator
Pembrolizumab administered in combination with carboplatin and pemetrexed.
干预措施: Pembrolizumab (Drug)
Sotorasib combined with carboplatin and pemetrexed
Experimental
Sotorasib administered in combination with carboplatin and pemetrexed.
干预措施: Sotorasib (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: Approximately 2.5 years
OS is defined as the time from randomization until death due to any cause.
Progression-free Survival (PFS)
时间窗: Approximately 2.5 years
PFS is defined as the time from randomization until the first documentation of radiologic disease progression or death due to any cause, whichever occurs first. Progression will be based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, per Blinded Independent Central Review (BICR).
次要结局
- Change in QLQ-LC13 Symptoms of Cough Subscale(From Baseline to Week 12)
- Minimum Plasma Concentration (Cmin) of Sotorasib(Pre-dose Day 1 up to Day 64)
- Area Under The Curve (AUC) of Sotorasib(Pre-dose Day 1 up to Day 64)
- Number of Participants With Clinically Significant Changes in Clinical Laboratory Tests(From Baseline up to EOS (approximately 5.5 years))
- Maximum Plasma Concentration (Cmax) of Sotorasib(Pre-dose Day 1 up to Day 64)
- Objective Response Rate (ORR)(From Baseline up to end of study (EOS) (approximately 5.5 years))
- Change in Quality-of-Life Questionnaire Core 30 (QLQ-C30) Dyspnea Domain Score(From Baseline to Week 12)
- Change in Quality-of-Life Questionnaire Lung Cancer 13 (QLQ-LC13) Symptoms of Dyspnea Subscale(From Baseline to Week 12)
- Change in QLQ-LC13 Symptoms of Chest Pain Subscale(From Baseline to Week 12)
- Change in Physical Function as Measured by QLQ-C30(From Baseline to Week 12)
- Change in Global Health Status as Measured by QLQ-C30(From Baseline to Week 12)
- Progression-free Survival 2 (PFS2)(From Baseline up to EOS (approximately 5.5 years))
- Change in QLQ-LC13 Subscale Scores(From Baseline up to EOS (approximately 5.5 years))
- Change in QLQ-C30 Subscale Scores(From Baseline up to EOS (approximately 5.5 years))
- Time to Deterioration in QLC-LC13 Subscale Scores(From Baseline to Week 12)
- Time to Deterioration in QLC-C30 Subscale Scores(From Baseline to Week 12)
- Change in Summary Scores and Visual Analogue Scale (VAS) Scores(From Baseline up to EOS (approximately 5.5 years))
- Duration of Response(From Baseline up to EOS (approximately 5.5 years))
- Time to Response(From Baseline up to EOS (approximately 5.5 years))
- Disease Control(From Baseline up to EOS (approximately 5.5 years))
- PFS(From Baseline up to EOS (approximately 5.5 years))
- Objective Response(From Baseline up to EOS (approximately 5.5 years))
- Number of Participants With Treatment-Emergent Adverse Events(From Baseline up to EOS (approximately 5.5 years))
- Number of Participants With Clinically Significant Changes in Vital Signs(From Baseline up to EOS (approximately 5.5 years))
研究者
研究点 (420)
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