a study of atezolizumab and tiragolumab compared with durvalumab in participants with locally advanced, unresectable stage iii non-small cell lung cancer (nsclc)

Conditions: Non-small Cell Lung Cancer (NSCLC)

Summary: the purpose of this study is to evaluate the efficacy and safety of atezolizumab in combination with tiragolumab compared with durvalumab in participants with locally advanced, unresectable stage iii non-small cell lung cancer (nsclc) who have received at least two cycles of concurrent platinum-based chemoradiotherapy (crt) and have not had radiographic disease progression.


Eligibility criteria:
inclusion criteria: * eastern cooperative oncology group (ecog) 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-computed tomography (pet-ct) scan, 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 radiotherapy (rt) component in the ccrt must have been at a total dose of radiation of 60 (±10 percent \[%\]) gray (gy) (54 gy to 66 gy) administered by intensity modulated rt (preferred) or 3d-conforming technique * no progression during or following concurrent platinum-based crt * a known pd-l1 result * life expectancy \>/= 12 weeks * adequate hematologic and end-organ function * female participants must be willing to avoid pregnancy for 90 days after the final dose of tiragolumab and 5 months after the final dose of atezolizumab, or for 3 months after the final dose of durvalumab * male participants must remain abstinent or use a condom during the treatment period and for 90 days after the final dose of tiragolumab * male participants must not donate sperm during the treatment period and for 90 days after the final dose of tiragolumab exclusion criteria: * any history of prior nsclc and/or any history of prior treatment for nsclc (participants must be newly diagnosed with unresectable stage iii disease) * nsclc known to have a mutation in the epidermal growth factor receptor (egfr) gene or an anaplastic lymphoma kinase (alk) fusion oncogene * any evidence of stage iv disease * treatment with sequential crt for locally advanced nsclc * participants with locally advanced nsclc who have progressed during or after the definitive ccrt prior to randomization * any grade \>2 unresolved toxicity from previous crt * grade \>= 2 pneumonitis from prior crt * active or history of autoimmune disease or immune deficiency * history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis or evidence of active pneumonitis * history of malignancy other than nsclc within 5 years prior to screening with the exception of malignancies with a negligible risk of metastasis or death * prior allogeneic stem cell or solid organ transplantation * active epstein-barr virus (ebv) infection or known or suspected chronic active ebv infection at screening * treatment with investigational therapy within 28 days prior to initiation of study treatment * prior treatment with cd137 agonists or immune checkpoint blockade therapies, including anti-cytotoxic t lymphocyte-associated protein 4, anti-t-cell immunoreceptor with ig and itim domains (anti-tigit), anti-pd-1 and anti-pd-l1 * any prior grade \>/= 3 immune-mediated adverse event or any unresolved grade \> 1 immune-mediated adverse event while receiving any previous immunotherapy agent other than immune checkpoint blockade agents * treatment with systemic immunosuppressive medication * women who are pregnant, or breastfeeding