Study of Pembrolizumab With Maintenance Olaparib or Maintenance Pemetrexed in First-line (1L) Metastatic Nonsquamous Non-Small-Cell Lung Cancer (NSCLC) (MK-7339-006, KEYLYNK-006)
Фаза 3
Завершено
NCT03976323
| Заболевание | Carcinoma, Nonsquamous Non-small-cell Lung |
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| Фаза | Фаза 3 |
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| Спонсор | Merck Sharp & Dohme LLC |
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| Статус | Завершено |
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| Участники | 1,003 участн. |
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| Вмешательство | Pembrolizumab, Pemetrexed, Carboplatin, Cisplatin, Olaparib |
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| Дата начала | 28.06.2019 |
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| Дата завершения | 7.02.2024 |
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| Публикация результатов | 6.02.2025 |
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Кратко
The current study will compare pembrolizumab (MK-3475) plus maintenance olaparib, versus (vs) pembrolizumab plus maintenance pemetrexed for the treatment of non-squamous NSCLC. The study's 2 primary hypotheses are: 1. Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance pemetrexed with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by blinded independent clinical review (BICR) and 2. Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance pemetrexed with respect to overall survival (OS).
Progression-free Survival (PFS)
Up to ~31 months · Months
| Pembrolizumab + Olaparib (Maintenance Phase) | 7.1 Months |
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| Pembrolizumab + Pemetrexed (Maintenance Phase) | 8.3 Months |
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| p-value | 0.8721 |
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| Hazard Ratio (HR) | 1.12 (95% CI 0.92–1.36) |
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Overall Survival (OS)
Up to ~51 months · Months
| Pembrolizumab + Olaparib (Maintenance Phase) | 20.7 Months |
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| Pembrolizumab + Pemetrexed (Maintenance Phase) | 23.0 Months |
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| p-value | 0.6649 |
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| Hazard Ratio (HR) | 1.04 (95% CI 0.87–1.25) |
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