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A Phase II, Open-Label, Multicenter Study Evaluating the Safety and Efficacy of Neoadjuvant and Adjuvant Tiragolumab Plus Atezolizumab, With or Without Platinum-Based Chemotherapy, in Patients With Previously Untreated Locally Advanced Resectable Stage II, IIIA, or Select IIIB Non-Small Cell Lung Cancer


Brief 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.



Inclusion and Exclusion 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

  • 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


Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.

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