NCT06875310招募中3 期
A Randomized, Double-Blind, Phase 3 Trial of Adagrasib Plus Pembrolizumab Plus Chemotherapy vs. Placebo Plus Pembrolizumab Plus Chemotherapy in Participants With Previously Untreated, Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-4)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 630
- 试验地点
- 349
- 主要终点
- Progression Free Survival (PFS) as Assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Blinded Independent Central Review (BICR)
研究概览
简要总结
This is a trial to evaluate the efficacy, safety, and tolerability of adagrasib plus pembrolizumab plus platinum-doublet chemotherapy versus placebo plus pembrolizumab plus platinum-doublet chemotherapy 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
- Quadruple (Participant, Care Provider, Investigator, 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
- •Histologically or cytologically confirmed diagnosis of non-squamous NSCLC with evidence of KRAS G12C mutation via tumor sample and/or circulating tumor deoxyribonucleic acid (ctDNA).
- •Locally advanced or metastatic disease.
- •Measurable disease via computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST v1.1 criteria of at least 1 lesion.
- •No prior systemic anti-cancer therapy given for advanced or metastatic disease.
- •Not a candidate for definitive therapy (eg, chemoradiation or complete surgical resection).
- •Participants with brain metastases are eligible for enrollment, including those with untreated brain metastases. Brain metastases must be asymptomatic and not in need of immediate local therapy. Any untreated brain metastases must be ≤ 20 mm in diameter.
- •Any PD-L1 expression (0 to 100%) as determined by VENTANA PD-L1 (SP263) assay, Agilent PD-L1 IHC 22C3 pharmDx, or Agilent PD-L1 IHC 28-8 pharmDx.
排除标准
- •Participants with an active autoimmune or inflammatory disease requiring systemic treatment within 2 years.
- •Uncontrolled or significant cardiovascular conditions within 6 months prior to enrollment that are ongoing or with risk of recurrence.
- •Inadequate bone marrow or liver function or electrocardiogram (ECG) abnormalities.
- •Ongoing treatment with concomitant medication known to cause prolonged QTc interval and that cannot be switched to alternative treatment prior to study entry.
- •Treatment targeting KRAS G12C mutation (eg, sotorasib, adagrasib) in any setting.
- •Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration.
- •Other protocol-defined Inclusion/Exclusion criteria apply.
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Pembrolizumab (Drug)
Adagrasib
Experimental
干预措施: Pembrolizumab (Drug)
Adagrasib
Experimental
干预措施: Carboplatin (Drug)
Placebo
Placebo Comparator
干预措施: Carboplatin (Drug)
Adagrasib
Experimental
干预措施: Cisplatin (Drug)
Placebo
Placebo Comparator
干预措施: Pemetrexed (Drug)
Adagrasib
Experimental
干预措施: Adagrasib (Drug)
Adagrasib
Experimental
干预措施: Pemetrexed (Drug)
Placebo
Placebo Comparator
干预措施: Cisplatin (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Progression Free Survival (PFS) as Assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Blinded Independent Central Review (BICR)
时间窗: Up to 7 years
Overall Survival (OS)
时间窗: Up to 7 years
次要结局
- PFS as Assessed per RECIST v1.1 by Investigator(Up to 7 years)
- Number of Participants With Adverse Events (AEs)(Up to 90 days from last dose)
- Number of Participants With Serious Adverse Events (SAEs)(Up to 90 days from last dose)
- Number of Participants With AEs Leading to Dose Interruption(Up to 90 days from last dose)
- Overall Response (OR) as Assessed per RECIST v1.1 by BICR(Up to 7 years)
- Duration of Response (DOR) as Assessed per RECIST 1.1 by BICR(Up to 7 years)
- Number of Participants With AEs Leading to Dose Reduction(Up to 90 days from last dose)
- Number of Participants With AEs Leading to Treatment Discontinuation(Up to 90 days from last dose)
- Number of Deaths(Up to 90 days from last dose)
- Time to Definitive Deterioration by Non-Small Cell Lung Cancer-Symptom Assessment Questionnaire (NSCLC-SAQ) Total Score(Up to 7 years)
- Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30) Scale/item Score(Up to 90 days from last dose)
研究者
研究点 (349)
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