A Study of Atezolizumab in Patients with Locally Advanced, Unresectable Stage III Non−Small Cell Lung Cancer who have already received chemotherapy and radiotherapy

Prior treatment

• Any history of prior NSCLC and/or any history of prior treatment for NSCLC (patients must be newly diagnosed with unresectable Stage III disease)
• Any Grade ≥ 2 unresolved toxicity and Grade ≥ 2 pneumonitis from previous cCRT
• Treatment with sequential CRT for locally advanced NSCLC
• Patients with locally advanced NSCLC who have progressed during or after definitive cCRT prior to baseline

Other illness

• Any evidence of Stage IV disease

Lab values

• NSCLC known to have a mutation in the epidermal growth factor (EGFR) gene or an anaplastic lymphoma kinase (ALK) fusion oncogene

• Ability to comply with the study protocol, including willingness to remain in the post-treatment period
• Histologically or cytologically documented NSCLC with locally advanced, unresectable Stage III NSCLC of either squamous or non-squamous histology
• 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
• 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)
• 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.
• 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