800-872-2273

Clinical Trials and Studies

Your participation matters. Help us discover and cure!

Contact us at (800) USC-CARE (800-872-2273)

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

Description

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.


Phase

N/A

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

Sites

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.

Powered by SC CTSI