A PHASE III, RANDOMIZED, DOUBLE-BLINDED, PLACEBO-CONTROLLED STUDY OF TIRAGOLUMAB, AN ANTI-TIGIT ANTIBODY, IN COMBINATION WITH ATEZOLIZUMAB COMPARED WITH PLACEBO IN COMBINATION WITH ATEZOLIZUMAB IN PATIENTS WITH PREVIOUSLY UNTREATED LOCALLY ADVANCED UNRESECTABLE OR METASTATIC PD-L1SELECTED NONSMALL CELL LUNG CANCER.
- Conditions
- -C349 Bronchus or lung, unspecifiedBronchus or lung, unspecifiedC349
- Registration Number
- PER-042-19
- Lead Sponsor
- F. HOFFMANN-LA ROCHE LTD.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 6
•Signed Informed Consent Form
•Age 18 years at time of signing Informed Consent Form
•Ability to comply with the study protocol, in the investigator´s judgment
•ECOG Performance Status of 0 or 1
•Histologically or cytologically documented locally advanced or recurrent NSCLC that is not
eligible for curative surgery and/or definitive chemoradiotherapy, or metastatic Stage IV
NSCLC
•No prior systemic treatment for metastatic NSCLC
Patients who received prior neo-adjuvant, adjuvant chemotherapy, and/or
chemoradiotherapy with curative intent for non-metastatic disease are eligible for the
study if the therapy was completed at least 6 months prior to initiation of study treatment.
•Tumor PD-L1 expression with a TPS 50%, as determined by the PD-L1 IHC 22C3
pharmDx assay and documented through central testing of a representative tumor tissue, in
either a previously obtained archival tumor tissue or tissue obtained from a biopsy at
screening
Confirmed
•Measurable disease per RECIST v1.1
•Life expectancy 12 weeks
•Adequate hematologic and end-organ function, defined by the following laboratory test
Results.
•For patients receiving therapeutic anticoagulation: stable anticoagulant regimen
•Negative HIV test at screening
•Negative hepatitis B surface antigen (HBsAg) test at screening
See protocol for more detail.
•NSCLC known to have a mutation in the EGFR gene or an ALK fusion oncogene are
excluded from the study.
•Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
Spinal cord compression not definitively treated with surgery and/or radiation, and/or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for 2 weeks prior to screening
•History of leptomeningeal disease
•Uncontrolled tumor-related pain
•Patients requiring pain medication must be on a stable regimen at study entry.
•Symptomatic lesions (e.g., bone metastases or metastases causing nerve impingement) amenable to palliative radiotherapy should be treated prior to enrollment. Patients should be recovered from the effects of radiation. There is no required minimum recovery period.
•Asymptomatic metastatic lesions that would likely cause functional deficits or intractable pain with further growth (e.g., epidural metastasis that is not currently associated with spinal cord compression) should be considered for loco-regional therapy if appropriate prior to enrollment.
•Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once a month or more frequently).
•Patients with indwelling catheters (e.g., PleurX®) are allowed regardless of drainage frequency.
•Uncontrolled or symptomatic hypercalcemia (ionized calcium 1.5 mmol/L, calcium 12 mg/dL, or corrected calcium greater than ULN)
•Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barre syndrome, or multiple sclerosis.
•History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan.
•History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
•Active tuberculosis
•Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, cirrhosis, and inherited liver disease, or current alcohol abuse.
•Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina.
See protocol for more detail.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:•PFS (progression-free survival) after randomization, defined as the time from randomization to the first occurrence of disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1<br>Measure:•PFS (progression-free survival)<br>Timepoints:Throughout study.<br>;<br>Outcome name:•OS (overall survival) after randomization, defined as the time from randomization to death from any cause.<br>Measure:•OS (overall survival)<br>Timepoints:Throughout study.<br>
- Secondary Outcome Measures
Name Time Method