Lung Cancer Clinical Trial
A Study Evaluating the Safety and Efficacy of Neoadjuvant and Adjuvant Tiragolumab Plus Atezolizumab, With or Without Platinum-Based Chemotherapy, in Participants With Previously Untreated Locally Advanced Resectable Stage II, IIIA, or Select IIIB Non-Small Cell Lung Cancer
Summary
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.
Eligibility Criteria
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
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There are 31 Locations for this study
Duarte California, 91010, United States
Irvine California, 92618, United States
Los Angeles California, 90033, United States
Los Angeles California, 90048, United States
Washington District of Columbia, 20016, United States
Westwood Kansas, 66205, United States
Saint Louis Missouri, 63110, United States
Mineola New York, 11501, United States
New York New York, 10016, United States
New York New York, 10032, United States
San Antonio Texas, 78229, United States
Birtinya Queensland, 4575, Australia
Malvern Victoria, 3144, Australia
Melbourne Victoria, 3000, Australia
Busan , 49267, Korea, Republic of
Gyeonggi-do , 16247, Korea, Republic of
Seoul , 003-7, Korea, Republic of
Seoul , 03080, Korea, Republic of
L'Hospitalet de Llobregat Barcelona, 08908, Spain
Sabadell Barcelona, 8208, Spain
A Coruña LA Coruña, 15006, Spain
Majadahonda Madrid, 28222, Spain
Barcelona , 08035, Spain
Madrid , 28041, Spain
Baden , 5404, Switzerland
Basel , 4031, Switzerland
Bern , 3010, Switzerland
Chur , 7000, Switzerland
St. Gallen , 9007, Switzerland
Winterthur , 8401, Switzerland
Zürich , 8091, Switzerland
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