Study of REGN 2810 Compared to Platinum-Based Chemotherapies in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC)
Фаза 3
Завершено
NCT03088540
| Заболевание | Carcinoma，Non-Small-Cell Lung, Lung Carcinomas, Non-Small-Cell, Non-small-cell Lung Carcinoma, Nonsmall Cell Lung Cancer |
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| Фаза | Фаза 3 |
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| Спонсор | Regeneron Pharmaceuticals |
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| Статус | Завершено |
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| Участники | 712 участн. |
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| Вмешательство | Pemetrexed, Paclitaxel, Gemcitabine, Cisplatin, Carboplatin |
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| Дата начала | 29.05.2017 |
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| Дата завершения | 18.04.2025 |
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| Публикация результатов | 25.06.2026 |
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Кратко
The primary objectives of the study are: * To compare the overall survival (OS) of cemiplimab versus standard-of-care platinum-based chemotherapies in the first-line treatment of patients with advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 in ≥50% of tumor cells * To compare the progression-free survival (PFS) of cemiplimab versus standard-of-care platinum-based chemotherapies in the first-line treatment of patients with advanced or metastatic NSCLC whose tumors express PD-L1 in ≥50% of tumor cells The key secondary objective of the study is to compare the objective response rate (ORR) of cemiplimab versus platinum-based chemotherapies
Overall Survival (OS)
Up to 94 months · months
| Cemiplimab | 23.4 months |
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| Chemotherapy | 13.7 months |
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| p-value | <0.0001 |
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| Hazard Ratio (HR) | 0.661 (95% CI 0.553–0.790) |
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Progression-free Survival (PFS) Per Blinded IRC
Up to 94 months · months
| Cemiplimab | 6.3 months |
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| Chemotherapy | 5.3 months |
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| p-value | <0.0001 |
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| Hazard Ratio (HR) | 0.559 (95% CI 0.469–0.665) |
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