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Sponsor: Hoffmann-La Roche
Conditions: Non-Small Cell Lung Cancer
Interventions: Atezolizumab, rHuPH20
Countries: Argentina, Brazil, Chile, China, Costa Rica, France, Greece, Guatemala
This study will evaluate the pharmacokinetics, safety, and efficacy of atezolizumab subcutaneous (SC) compared with atezolizumab intravenous (IV) in participants with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) who have not been exposed to cancer immunotherapy (CIT) and for whom prior platinum-based therapy has failed. The study is comprised of two parts, as follows: A dose-finding part (Part 1, Phase Ib) will aim to identify the dose of atezolizumab SC to be tested in Part 2. A dose-confirmation part (Part 2, Phase III, randomized) will aim to confirm that the dose moved forward from Part 1 yields drug exposure that is comparable to that of atezolizumab IV.
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria: * Histologically or cytologically documented locally advanced or metastatic NSCLC * Prior platinum-containing regimen or disease recurrence ≤ 6 months since prior platinum-based adjuvant/neoadjuvant regimen. * Measurable disease as defined by RECIST v1.1 * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Life expectancy ≥12 weeks * Adequate hematologic and end-organ function Additional Inclusion Criteria (Part 2 Only) • Availability of tissue and known epidermal growth factor receptor (EGFR) status Exclusion Criteria: * Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases * Uncontrolled or symptomatic hypercalcemia * Pregnancy or breastfeeding * 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 * Severe infection ≤ 4 weeks * Treatment with therapeutic oral or IV antibiotics ≤ 2 weeks prior to study treatment * Significant cardiovascular disease * Prior allogeneic stem cell or solid organ transplantation * Treatment with a live, attenuated vaccine ≤ 4 weeks * Treatment with systemic immunostimulatory agents ≤ 4 weeks or 5 half-lives of the drug * Treatment with systemic immunosuppressive medication ≤ 2 weeks Additional Exclusion Criteria (Part 2 Only) • Tested tumor programmed death-ligand-1 (PD-L1) expression status with an intention to treat the patient if positive
- Buenos Aires, Argentina
- La Rioja, Argentina
- Salta, Argentina
- Ijuí, Rio Grande do Sul, Brazil
- Porto Alegre, Rio Grande do Sul, Brazil
- São Paulo, São Paulo, Brazil
- Rio de Janeiro, Brazil
- Recoleta, Chile
- Temuco, Chile
- Viña del Mar, Chile
- Changchun, China
- Chengdu, China
- Hangzhou, China
- Jinan, China
- Zhengzhou, China
- San José, Costa Rica
- San José, Costa Rica
- Marseille, France
- Saint-Herblain, France
- Asvestochóri, Greece
- Athens, Greece
- Guatemala City, Guatemala
- Guatemala City, Guatemala
- Guatemala City, Guatemala
- Guatemala City, Guatemala
- Mátraháza, Hungary
- Törökbálint, Hungary
- Bergamo, Lombardy, Italy
- Rozzano, Lombardy, Italy
- Riga, Latvia
- + 44 more on CT.gov