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
- lung cancerSmall cell lung cancer1003866610029107
- Registration Number
- NL-OMON52819
- Lead Sponsor
- Roche
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 26
- Age > 18 years
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- Histologically or cytologically documented locally advanced or recurrent
NSCLC
- No prior systemic treatment for metastatic NSCLC
- Tumor PD-L1 expression as determined by PD-L1 IHC assay TPS >= 50% as
determined by 22C3 pharmaDx assay TC3 or IC3 as determined by the VENTANA PD-L1
Assay (SP142), or TC >= 50% as determined by the investigational VENTANA PD-L1
CDx Assay (SP263) of tumor tissue
- Measurable disease per Response Evaluation Criteria in Solid Tumors, Version
1.1 (RECIST v1.1)
- Adequate hematologic and end-organ function.
- Known to have a mutation in the EGFR gene or an ALK fusion oncogene
- Symptomatic, untreated, or actively progressing central nervous system
metastases
- Active or history of autoimmune disease or immune deficiency
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced
pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis
- Significant cardiovascular disease
- History of malignancy other than NSCLC within 5 years prior to screening,
with the exception of malignancies with a negligible risk of metastasis or death
- Severe infection within 4 weeks prior to initiation of study treatment
- Current treatment with anti-viral therapy for HBV or HCV
- Treatment with investigational therapy within 28 days prior to initiation of
study treatment
- Prior treatment with CD137 agonists or immune checkpoint blockade therapies
- Treatment with systemic immunostimulatory agents or anticipation of need for
systemic immunosuppressive medication during study treatment prior to
initiation of study treatment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>-PFS after randomization, defined as the time from randomization to the first<br /><br>occurrence of disease progression or death from any cause (whichever occurs<br /><br>first), as determined by the investigator according to RECIST v1.1, in the<br /><br>primary analysis set<br /><br><br /><br>-OS after randomization, defined as the time from randomization to death from<br /><br>any cause, in the primary analysis set</p><br>
- Secondary Outcome Measures
Name Time Method