Non-small cell lung cancer (NSCLC)
Conditions
Brief summary
1. ORR as determined by the investigator according to RECIST v1.1, 2. PFS as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurs first
Detailed description
1. DOR as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurs first, 2. Overall survival, 3. Incidence, nature, and severity of adverse events, graded according to the NCI CTCAE v4.0, 4. Clinically significant changes from baseline in vital signs, physical findings, and clinical laboratory results, 5. Serum concentrations of tiragolumab or atezolizumab at specified timepoints, 6. Incidence of treatment-emergent Anti-drug antibodies (ADAs) and their potential impact on safety, efficacy, and pharmacokinetics
Interventions
Sponsors
Genentech Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. ORR as determined by the investigator according to RECIST v1.1, 2. PFS as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurs first | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. DOR as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurs first, 2. Overall survival, 3. Incidence, nature, and severity of adverse events, graded according to the NCI CTCAE v4.0, 4. Clinically significant changes from baseline in vital signs, physical findings, and clinical laboratory results, 5. Serum concentrations of tiragolumab or atezolizumab at specified timepoints, 6. Incidence of treatment-emergent Anti-drug antibodies (ADAs) and their potential impact on safety, efficacy, and pharmacokinetics | — |
Countries
France, Spain
Outcome results
None listed