Status:
COMPLETED
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
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Non-Small Cell Lung Cancer (NSCLC)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 pr...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 5 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04832854
Start Date
April 23 2021
End Date
March 5 2025
Last Update
March 18 2025
Active Locations (22)
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1
City of Hope Cancer Center
Duarte, California, United States, 91010
2
City of Hope at Irvine Lennar
Irvine, California, United States, 92618
3
University of Southern California
Los Angeles, California, United States, 90033
4
Washington University School of Medicine
St Louis, Missouri, United States, 63110