Testing the Addition of a New Immunotherapy Drug, Atezolizumab (MPDL3280A), to the Usual Chemoradiation (CRT) Therapy Treatment for Limited Stage Small Cell Lung Cancer (LS-SCLC)
第3相
実施中(募集終了)
NCT03811002
| 対象疾患 | Limited Stage Lung Small Cell Carcinoma, Stage I Lung Cancer AJCC v8, Stage II Lung Cancer AJCC v8, Stage III Lung Cancer AJCC v8 |
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| 相 | 第3相 |
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| スポンサー | National Cancer Institute (NCI) |
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| ステータス | 実施中(募集終了) |
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| 参加者数 | 544 名 |
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| 介入(薬剤) | 3-Dimensional Conformal Radiation Therapy, Atezolizumab, Biospecimen Collection, Carboplatin, Cisplatin |
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| 開始日 | 2019年7月26日 |
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| 完了日 | 2024年4月21日 |
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| 結果公開日 | 2025年6月12日 |
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概要
This phase III trial studies how well chemotherapy and radiation therapy (chemoradiation) with or without atezolizumab works in treating patients with limited stage small cell lung cancer. Drugs used in chemotherapy, such as etoposide, cisplatin, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving chemoradiation with or without atezolizumab may work better in treating patients with limited stage small cell lung cancer.
Overall Survival
Randomization to date of death due or last follow-up. Median follow-up at the time of analysis was 23.8 months. · months
| Arm I (Chemotherapy, Radiation Therapy) | 36.1 months |
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| Arm II (Chemotherapy, Radiation Therapy, Atezolizumab) | 31.1 months |
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| p-value | 0.5819 |
| Hazard Ratio (HR) | 1.05 (95% CI 0.82–1.34) |
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