Study to Assess Safety and Efficacy of Atezolizumab (MPDL3280A) Compared to Best Supportive Care Following Chemotherapy in Patients With Lung Cancer [IMpower010]
Фаза 3
Идёт, набор закрыт
NCT02486718
| Заболевание | Non-Small Cell Lung Cancer |
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| Фаза | Фаза 3 |
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| Спонсор | Hoffmann-La Roche |
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| Статус | Идёт, набор закрыт |
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| Участники | 1,280 участн. |
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| Вмешательство | Atezolizumab, Cisplatin, Vinorelbine, Docetaxel, Gemcitabine |
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| Дата начала | 31.10.2015 |
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| Дата завершения | 26.01.2024 |
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| Публикация результатов | 30.03.2025 |
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Кратко
This is a Phase III, global, multicenter, open-label, randomized study to compare the efficacy and safety of 16 cycles (1 cycle duration=21 days) of atezolizumab (MPDL3280A) treatment compared with best supportive care (BSC) in participants with Stage IB-Stage IIIA non-small cell lung cancer (NSCLC) following resection and adjuvant chemotherapy, as measured by disease-free survival (DFS) as assessed by the investigator and overall survival (OS). Participants, after completing up to 4 cycles of adjuvant cisplatin-based chemotherapy, will be randomized in a 1:1 ratio to receive atezolizumab for 16 cycles or BSC.
Disease-Free Survival (DFS) in Intent-to-treat (ITT) Population
Up to 95 months · months
| Atezolizumab | 65.6 months |
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| Best Supportive Care (BSC) | 47.8 months |
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| p-value | 0.0683 |
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| Hazard Ratio (HR) | 0.848 (95% CI 0.710–1.013) |
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DFS in All Randomized Stage II-IIIA Population
Up to 95 months · months
| Atezolizumab | 57.4 months |
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| Best Supportive Care (BSC) | 40.8 months |
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| Hazard Ratio (HR) | 0.830 (95% CI 0.691–0.998) |
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DFS in the Programmed Death-ligand 1 (PD-L1) SP263 ≥ 1% Tumor Cell (TC) Subpopulation Within the Stage II-IIIA Population
Up to 95 months · months
| Atezolizumab | 68.5 months |
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| Best Supportive Care (BSC) | 37.3 months |
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| Hazard Ratio (HR) | 0.704 (95% CI 0.545–0.910) |
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