A Phase III, Open-Label, Randomized Study of Atezolizumab and Tiragolumab Compared with Durvalumab in Patients with Locally Advanced, Unresectable Stage III Non-Small Cell Lung Cancer who have not Progressed after Concurrent Platinum-Based Chemoradiation (SKYSCRAPER-03) - GO41854

F. Hoffmann-La Roche AG0 个研究点目标入组 813 人开始时间: 2024年6月11日最近更新: 2024年8月21日

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•Eastern Cooperative Oncology Group Performance Status of 0 or 1, Histologically or cytologically documented NSCLC with locally advanced unresectable Stage III NSCLC of either squamous or non-squamous histology, Whole-body positron emission tomography (PET)-CT scan for the purposes of staging, performed prior and within 42 days of the first dose of concurrent chemoradiotherapy (cCRT), At least two prior cycles of platinum-based chemotherapy administered concurrently with radiotherapy (RT), which must be completed within 1 to 42 days prior to randomization in the study (one cycle of cCRT is defined as 21 or 28 days), The RT component in the cCRT must have been at a total dose of radiation of 60 Gy ± 10% (54 Gy to 66 Gy) administered by intensity-modulated radiotherapy (preferred) or 3D-conforming technique, No progression during or following concurrent platinum-based CRT

•Any history of prior NSCLC and/or any history of prior treatment for NSCLC (patients must be newly diagnosed with unresectable Stage III disease), NSCLC known to have a mutation in the epidermal growth factor (EGFR) gene or an anaplastic lymphoma kinase (ALK) fusion oncogene, Any evidence of Stage IV disease, Treatment with sequential CRT for locally advanced NSCLC, Patients with locally advanced NSCLC who have progressed during or after the definitive cCRT prior to randomization, Any Grade > 2 unresolved toxicity from previous CRT

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