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)
- Registration Number
- NCT04513925
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1<br><br> - Histologically or cytologically documented NSCLC with locally advanced, unresectable<br> Stage III NSCLC of either squamous or non-squamous histology<br><br> - Whole-body Positron Emission Tomography-Computed Tomography (PET-CT) scan, performed<br> prior and within 42 days of the first dose of concurrent chemoradiotherapy (cCRT)<br><br> - At least two prior cycles of platinum-based chemotherapy administered concurrently<br> with radiotherapy (RT), which must be completed within 1 to 42 days prior to<br> randomization in the study (one cycle of cCRT is defined as 21 or 28 days)<br><br> - The radiotherapy (RT) component in the cCRT must have been at a total dose of<br> radiation of 60 (±10 percent [%]) gray (Gy) (54 Gy to 66 Gy) administered by<br> intensity modulated RT (preferred) or 3D-conforming technique<br><br> - No progression during or following concurrent platinum-based CRT<br><br> - A known PD-L1 result<br><br> - Life expectancy >/= 12 weeks<br><br> - Adequate hematologic and end-organ function<br><br> - Female participants must be willing to avoid pregnancy for 90 days after the final<br> dose of tiragolumab and 5 months after the final dose of atezolizumab, or for 3<br> months after the final dose of durvalumab<br><br> - Male participants must remain abstinent or use a condom during the treatment period<br> and for 90 days after the final dose of tiragolumab<br><br> - Male participants must not donate sperm during the treatment period and for 90 days<br> after the final dose of tiragolumab<br><br>Exclusion Criteria:<br><br> - Any history of prior NSCLC and/or any history of prior treatment for NSCLC<br> (participants must be newly diagnosed with unresectable Stage III disease)<br><br> - NSCLC known to have a mutation in the epidermal growth factor receptor (EGFR) gene<br> or an anaplastic lymphoma kinase (ALK) fusion oncogene<br><br> - Any evidence of Stage IV disease<br><br> - Treatment with sequential CRT for locally advanced NSCLC<br><br> - Participants with locally advanced NSCLC who have progressed during or after the<br> definitive cCRT prior to randomization<br><br> - Any Grade >2 unresolved toxicity from previous CRT<br><br> - Grade >= 2 pneumonitis from prior CRT<br><br> - Active or history of autoimmune disease or immune deficiency<br><br> - History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced<br> pneumonitis, or idiopathic pneumonitis or evidence of active pneumonitis<br><br> - History of malignancy other than NSCLC within 5 years prior to screening with the<br> exception of malignancies with a negligible risk of metastasis or death<br><br> - Prior allogeneic stem cell or solid organ transplantation<br><br> - Active Epstein-Barr virus (EBV) infection or known or suspected chronic active EBV<br> infection at screening<br><br> - Treatment with investigational therapy within 28 days prior to initiation of study<br> treatment<br><br> - Prior treatment with CD137 agonists or immune checkpoint blockade therapies,<br> including anti-cytotoxic T lymphocyte-associated protein 4, anti-T-cell<br> immunoreceptor with Ig and ITIM domains (anti-TIGIT), anti-PD-1 and anti-PD-L1<br><br> - Any prior Grade >/= 3 immune-mediated adverse event or any unresolved Grade > 1<br> immune-mediated adverse event while receiving any previous immunotherapy agent other<br> than immune checkpoint blockade agents<br><br> - Treatment with systemic immunosuppressive medication<br><br> - Women who are pregnant, or breastfeeding
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Independent Review Facility (IRF)-assessed Progression Free Survival (PFS) in the PD-L1-positive Analysis Set (PPAS);IRF-assessed PFS in the Full Analysis Set (FAS)
- Secondary Outcome Measures
Name Time Method