A Phase II, Single-Arm Study of Atezolizumab in Patients with Locally Advanced, Unresectable Stage III Non-Small Cell Lung Cancer who have not Progressed after Platinum-Based Concurrent Chemoradiation - MO43156

F. Hoffmann-La Roche AG0 个研究点目标入组 130 人开始时间: 2024年1月11日最近更新: 2024年8月21日

适应症

试验速览

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•1. Ability to comply with the study protocol, including willingness to remain in the post-treatment period, 2. Histologically or cytologically documented NSCLC with locally advanced, unresectable Stage III NSCLC of either squamous or non-squamous histology, 3. Whole-body positron emission tomography–computed tomography (PET-CT) scan (from the base of skull to mid-thighs) for the purposes of staging, performed prior and within 42 days of the first dose of cCRT, 4. At least two prior cycles of platinum-based chemotherapy administered concurrently with radiotherapy (cCRT) completed within 1 to 42 days prior to baseline (one cycle of cCRT is defined as 21 or 28 days), 5. The radiotherapy (RT) component in the cCRT must have been at a total radiation dose of 60 (± 10%) Gy (54 Gy to 66 Gy), administered either as IMRT (preferred) or by 3D-conforming technique., 6. A known Programmed Cell Death 1–Ligand 1 (PD-L1) result, as determined by the investigational Ventana PD-L1 (SP263) CDx Assay and documented by means of central testing of a representative tumor tissue sample, in either a previously obtained archival tumor tissue sample or a fresh tissue sample obtained from a biopsy collected prior to the first dose of cCRT

•1. Any history of prior NSCLC and/or any history of prior treatment for NSCLC (patients must be newly diagnosed with unresectable Stage III disease), 2. NSCLC known to have a mutation in the epidermal growth factor (EGFR) gene or an anaplastic lymphoma kinase (ALK) fusion oncogene, 3. Any evidence of Stage IV disease, 4. Any Grade = 2 unresolved toxicity and Grade = 2 pneumonitis from previous cCRT, 5. Treatment with sequential CRT for locally advanced NSCLC, 6. Patients with locally advanced NSCLC who have progressed during or after definitive cCRT prior to baseline

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