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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Atezolizumab 1200 mg will be administered by intravenous (IV) infusion on Day 1 of each 21-day cycle.
Tiragolumab 600 mg will be administered by IV infusion on Day 1 of each 21-day cycle.
Carboplatin at initial target area under the concentration curve (AUC) of 5 or 6 mg/mL/min will be administered by IV infusion on Day 1 of each 21-day cycle.
Cisplatin at 75 mg/m\^2 will be administered by IV infusion on Day 1 of each 21-day cycle.
Pemetrexed at 500 mg/m\^2 will be administered by IV infusion on Day 1 of each 21-day cycle.
Gemcitabine at 1000 or 1250 mg/m\^2 will be administered by IV infusion on Days 1 and 8 of each 21-day cycle.
Paclitaxel at 175 or 200 mg/m\^2 will be administered by IV infusion on Day 1 of each 21-day cycle.
City of Hope Cancer Center
Duarte, California, United States
City of Hope at Irvine Lennar
Irvine, California, United States
University of Southern California
Los Angeles, California, United States
Washington University School of Medicine
St Louis, Missouri, United States
Winthrop Univ Hospital
Mineola, New York, United States
NYU Cancer Center
New York, New York, United States
Columbia University
New York, New York, United States
Sunshine Coast University Hospital
Birtinya, Queensland, Australia
Peter Maccallum Cancer Institute
Melbourne, Victoria, Australia
St. Vincent's Hospital
Gyeonggi-do, South Korea
...and 12 more locations
Number of Participants With Surgical Delays
Time frame: Up to approximately 6 years
Number of Participants With Operative and Post-operative Complications
Time frame: Up to approximately 6 years
Number of Participants With Surgical Cancellations Related to Study Treatment
Time frame: Up to approximately 6 years
Percentage of Participants With Adverse Events
Time frame: Up to approximately 6 years
Percentage of Participants Who Achieve Major Pathological Response (MPR)
Time frame: At the time of surgery (approximately Weeks 17-20)
Percentage of Participants With Pathological Complete Response (pCR)
Time frame: At the time of surgery (approximately Weeks 17-20)
Event Free Survival (EFS)
Time frame: From baseline to disease progression that precludes surgical resection, or local or distant disease recurrence after surgery, or death from any cause (up to approximately 6 years)
Serum Concentrations of Atezolizumab
Time frame: Day 1 of Cycle 1 (cycle=21 days): pre-dose and 30 minutes (min) post-dose; Day 1 of Cycles 2, 3, 4, 5, 8, 12, 16: pre-dose; at treatment discontinuation (TD) visit (up to approximately 9 months)
Serum Concentrations of Tiragolumab
Time frame: Day 1 of Cycle 1 (cycle=21 days): pre-dose and 30 min post-dose; Day 1 of Cycles 2, 3, 4, 5, 8, 12, 16: pre-dose; at TD visit (up to approximately 9 months)
Percentage of Participants With Anti-drug Antibodies (ADAs) to Atezolizumab
Time frame: Prior to the first infusion on Day 1 of Cycles 1, 2, 3, 4, 5, 8, 12 and 16 (cycle=21 days) and at TD visit (up to approximately 9 months)
Percentage of Participants With ADAs to Tiragolumab
Time frame: Prior to the first infusion on Day 1 of Cycles 1, 2, 3, 4, 5, 8, 12 and 16 (cycle=21 days) and at TD visit (up to approximately 9 months)
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