2024-514500-14-00
尚未招募
3 期
A Phase 3, Randomized, Open-label, Multicenter Clinical Study to Evaluate the Safety and Efficacy of MK-1084 in Combination With Subcutaneous Pembrolizumab and Berahyaluronidase alfa (MK-3475A) Versus MK-3475A in Combination With Pemetrexed/Platinum (Carboplatin or Cisplatin) Chemotherapy as First-line Treatment of Participants With KRAS G12C-Mutant, Advanced or Metastatic Nonsquamous NSCLC (KANDLELIT-007)
概览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 206
- 试验地点
- 54
- 主要终点
- Progression Free Survival (PFS) in Participants with Programmed Death-Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1%
概览
简要总结
- To compare MK-1084 plus MK-3475A and MK-3475A plus platinum-doublet chemotherapy with respect to PFS per RECIST 1.1 by BICR in participants whose tumors are PD-L1 positive at TPS≥1%
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Has nonsquamous non—small cell lung cancer (NSCLC) (Stage IIIB, Stage IIIC) not eligible for curative resection or chemoradiation or Stage IV: M1a, M1b, or M1c
- •If human immunodeficiency virus (HIV) positive, must have well controlled HIV on antiretroviral therapy (ART)
排除标准
- •Has diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements
- •History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- •Has active infection requiring systemic therapy except those specified by protocol
- •Has history of stem cell/solid organ transplant
- •Has not adequately recovered from major surgery or has ongoing surgical complications
- •Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis, or chronic diarrhea)
- •Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
- •Has a gastrointestinal disorder affecting absorption
- •Is HIV positive and has a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease
- •Has received prior systemic anticancer therapy for their advanced or metastatic NSCLC
结局指标
主要结局
Progression Free Survival (PFS) in Participants with Programmed Death-Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1%
Progression Free Survival (PFS) in Participants with Programmed Death-Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1%
次要结局
- PFS in All Participants
- Overall Survival (OS) in Participants with PD-L1 TPS ≥1%
- OS in All Participants
- Overall Response Rate (ORR) in All Participants
- ORR in Participants with PD-L1 TPS ≥1%
- Duration of Response (DOR)
- Number of Participants Who Experienced One or More Adverse Events (AEs)
- Number of Participants Who Discontinued Study Treatment Due to an AE
- Change from Baseline in Global Health Status/Quality of Life (GHS/QoL) (Items 29, 30) on the European Organization for Research and Treatment of Cancer QoL Questionnaire-Core 30 (EORTC QLQ-C30)
- Change from Baseline in Dyspnea Score (Item 8) on the EORTC QLQ-C30
- Change from Baseline in Cough Score (Item 31) on the European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire (EORTC QLQ-LC13)
- Change from Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13
- Time to Deterioration (TTD) in GHS/QoL (Items 29, 30) on the EORTC QLQ-C30
- TTD in Dyspnea Score (Item 8) on the EORTC QLQ-C30
- TTD in Cough Score (Item 31) on the EORTC QLQ-LC13
- TTD in Chest Pain Score (Item 40) on the EORTC QLQ-LC13
研究者
Atsuko Ogino
Scientific
Merck Sharp & Dohme LLC
研究点 (54)
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