Non-small cell lung cancer (NSCLC) MedDRA version: 21.1 Level: PT Classification code 10059515 Term: Non-small cell lung cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.1 Level: PT Classification code 10061873 Term: Non-small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age >= 18 years - Eastern Cooperative Oncology Group Performance Status of 0 or 1 - Histologically or cytologically documented locally advanced or recurrent NSCLC not eligible for curative surgery and/or definitive radiotherapy with or without chemotherapy, or metastatic Stage IV 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 - For patients enrolled in the extended China enrollment phase: current resident of mainland China or Taiwan and of Chinese ancestry. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 284 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 276
Exclusion criteria
Exclusion criteria: - 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, with the exception of malignancies with a negligible risk of metastasis or death treated with curative intent - Severe infection within 4 weeks prior to initiation of study treatment - Positive test result for human immunodeficiency virus (HIV) - Active hepatitis B or hepatitis C infection- Treatment with investigational therapy within 28 days prior to initiation of study treatment - 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 within 4 weeks or 5 drug elimination half-lives prior to initiation of study treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of tiragolumab plus atezolizumab compared with placebo plus atezolizumab on the basis of the progression-free survival (PFS) and overall survival (OS) in the primary analysis population.;Secondary Objective: • To evaluate the efficacy of tiragolumab plus atezolizumab compared with placebo plus atezolizumab on the basis of the Investigator assessed PFS and OS in the secondary analysis population, confirmed overall response rate (ORR), duration of response (DOR), PFS rate at 6 months and 12 months, OS rate at 12 months and 24 months, time to confirmed deterioration and global health status/quality of life • To evaluate the safety and tolerability of tiragolumab plus atezolizumab compared with placebo plus atezolizumab • To characterize pharmacokinetics of tiragolumab and atezolizumab • To evaluate the immune response to tiragolumab plus atezolizumab.;Primary end point(s): 1. PFS as determined by the investigator according to RECIST v1.1 in the primary analysis population 2. OS in the primary analysis population. ;Timepoint(s) of evaluation of this end point: 1-2. Up to 59 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Investigator assessed PFS according to RECIST v1.1 in the secondary analysis population 2. Investigator assessed OS according to RECIST v1.1 in the secondary analysis population 3. Confirmed ORR as determined by the investigator according to RECIST v1.1 4. DOR for patients with confirmed ORR as determined by the investigator according to RECIST v1.1 5. PFS rate at 6 months and 12 months as determined by the investigator according to RECIST v1.1 6. OS rate at 12 months and 24 months 7. Time to confirmed deterioration in patient-reported physical functioning and global health status/quality of life, as measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer 8. Incidence and severity of adverse events, with severity determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 9. Minimum serum concentration (Cmin) and Maximum serum concentrate (Cmax) of tiragolumab 10. Cmin and Cmax of atezolizumab 11. Prevalence of ADAs to tiragolumab and atezolizumab at baseline and during the study. ;Timepoint(s) of evaluation of this end point: 1-11. Up to 59 months | — |
Countries
Argentina, Australia, Austria, Brazil, China, Denmark, Germany, Greece, Hungary, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Peru, Poland, Russian Federation, Serbia, Spain, Switzerland, Taiwan, Thailand, Türkiye, Ukraine, United States
Contacts
Public ContactTrial Information Support Line-TISL
Genentech Inc. c/o F. Hoffmann-La Roche Ltd
Outcome results
None listed