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Sponsor: Hoffmann-La Roche
Conditions: Non-Small Cell Lung Cancer (NSCLC)
Interventions: Atezolizumab, Tiragolumab, Carboplatin, Cisplatin, Pemetrexed
Countries: United States, Australia, South Korea, Spain, Switzerland
This study will evaluate the surgical safety and feasibility of atezolizumab plus tiragolumab alone or in combination with platinum-based chemotherapy as neoadjuvant treatment for participants with previously untreated locally advanced non-small cell lung cancer (NSCLC). The study will also evaluate the efficacy, pharmacokinetics, immunogenicity, and safety of atezolizumab plus tiragolumab alone or in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by adjuvant atezolizumab plus tiragolumab or adjuvant platinum-based chemotherapy.
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Key inclusion criteria: * Histologically or cytologically confirmed Stage II, IIIA, or select IIIB (T3N2 only) NSCLC of squamous or non-squamous histology * Eligible for R0 resection with curative intent at the time of screening * Adequate pulmonary function to be eligible for surgical resection with curative intent * Eligible to receive a platinum-based chemotherapy regimen * Measurable disease, as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 * Availability of a representative tumor specimen that is suitable for determination of PD-L1 status * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Normal life expectancy, excluding lung cancer mortality risk * Adequate hematologic and end-organ function * Negative human immunodeficiency virus (HIV) test at screening * Negative serology for active hepatitis B virus (HBV) and active hepatitis C virus (HCV) at screening Key Exclusion Criteria: * NSCLC with histology of large cell neuroendocrine carcinoma, sarcomatoid carcinoma, or NSCLC not otherwise specified * Small cell lung cancer (SCLC) histology or NSCLC with any component of SCLC * Any prior therapy for lung cancer * Active or history of autoimmune disease or immune deficiency * History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan * Active tuberculosis * Significant cardiovascular disease * NSCLC with an activating EGFR mutation or ALK fusion oncogene * Known c-ros oncogene 1 (ROS1) rearrangement * History of malignancy other than NSCLC within 5 years prior to screening, with the exception of malignancies with negligible risk of metastasis or death * Severe infection within 4 weeks prior to initiation of study treatment or any active infection that, in the opinion of the investigator, could impact patient safety * Prior treatment with CD127 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, anti-TIGIT, and anti-PD-L1 therapeutic antibodies * Treatment with systemic immunostimulatory agents * Treatment with systemic immunosuppressive medication * Pregnancy or breastfeeding
- Duarte, California, United States
- Los Angeles, California, United States
- St Louis, Missouri, United States
- Mineola, New York, United States
- New York, New York, United States
- New York, New York, United States
- Birtinya, Queensland, Australia
- Melbourne, Victoria, Australia
- Gyeonggi-do, South Korea
- Seoul, South Korea
- L'Hospitalet de Llobregat, Barcelona, Spain
- Sabadell, Barcelona, Spain
- Majadahonda, Madrid, Spain
- A Coruña, Spain
- Barcelona, Spain
- Madrid, Spain
- Baden, Switzerland
- Chur, Switzerland
- Sankt Gallen, Switzerland
- Winterthur, Switzerland
- Zurich, Switzerland