A Study of Sotorasib (AMG 510) in Participants With Stage IV NSCLC Whose Tumors Harbor a KRAS p.G12C Mutation in Need of First-line Treatment
2期
提前终止
NCT04933695
| 适应症 | Non-small Cell Lung Cancer |
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| 分期 | 2期 |
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| 申办方 | Amgen |
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| 状态 | 提前终止 |
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| 受试者人数 | 42 人 |
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| 干预（药物） | Sotorasib |
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| 开始日期 | 2022年1月28日 |
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| 完成日期 | 2025年5月28日 |
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| 结果公布日 | 2026年7月13日 |
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摘要
The main objective of this study is to evaluate the tumor objective response rate (ORR) assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria in participants who receive sotorasib at either 960 mg daily or 240 mg daily whose tumors are programmed death-ligand 1 (PD-L1) Tumor Proportion Score (TPS) \< 1% and/or harbor a serine/threonine kinase 11 (STK11) co-mutation, in a subgroup of participants with PD-L1 \< 1% and in a subgroup of participants with STK11 co-mutation.
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Blinded Independent Central Review (BICR)
From the first dose of trial drug until min (last dose + 30 days, end of trial [EOT]); median [min, max] duration was 5.32 [0.8, 30.9] months · percentage of participants
| Sotorasib | 26.8 percentage of participants |
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