A Phase III, Randomized, Double-Blind Study of Tiragolumab Plus Atezolizumab Compared with Placebo Plus Atezolizumab in Participants with Completely Resected Stage IIB, IIIA, or Select IIIB, PD-L1 Positive, Non-Small Cell Lung Cancer who have received Adjuvant Platinum-Based Chemotherapy - GO45006

F. Hoffmann-La Roche AG0 个研究点目标入组 1,150 人开始时间: 2024年1月25日最近更新: 2024年8月21日

适应症

试验速览

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•1. Eastern Cooperative Oncology Group performance status of 0 or 1, 2. Histological or cytological diagnosis of Stage IIB, IIIA, and select IIIB (T3N2) NSCLC of either non-squamous or squamous histology, 3. Participants must have had complete resection of NSCLC (no residual tumor and all surgical margins negative for invasive carcinoma), 4. At a minimum, mediastinal lymph node systematic sampling will have occurred, though complete mediastinal lymph node dissection (MLND) is preferred, 5. Participants must have received between one to four cycles (four preferred) of adjuvant histology-based platinum doublet chemotherapy: cisplatin (preferred) or carboplatin, with pemetrexed (non-squamous), gemcitabine, docetaxel, vinorelbine, etoposide, or paclitaxel, 6. Participants must have recovered adequately from surgery and from adjuvant chemotherapy (no Grade > 2 unresolved toxicity)

•1. Any history of prior NSCLC within the last 5 years, 2. Previous NSCLC must have been treated with surgery only, 3. Any evidence of residual disease or disease recurrence following surgical resection of NSCLC, or during or following adjuvant chemotherapy, 4. NSCLC with a mutation in the EGFR gene or an ALK fusion oncogene, 5. Prior treatment with systemic therapy (e.g., chemotherapy or immunotherapy) for the treatment of NSCLC, with the exception of adjuvant platinum-based chemotherapy as outlined in the inclusion criteria

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