Non-squamous non-small cell lung cancer (NSCLC)
Conditions
Brief summary
1. Investigator-Assessed Confirmed Objective Response Rate (ORR) (Phase 2), 2. Investigator-Assessed Progression-free survival (PFS) (Phase 2 and Phase 3), 3. Overall survival (Phase 3)
Detailed description
1. Overall survival (Phase 2), 2. PFS as determined by an independent review facility (IRF) (Phase 3), 3. PFS and OS in patients with PD L1 expression at TC ≥50% and TC ≥1% cut-off, as determined by central testing with Ventana PD-L1 (SP263) assay (Phase 3), 4. PFS at 6 months and 12 months (Phase 3), 5. OS rate at 12 months and 24 months (Phase 3), 6. Confirmed ORR (Phase 3), 7. Duration of response for patients with a confirmed objective response, defined as the time from first occurrence of a confirmed objective response to disease progression or death from any cause (whichever occurs first) (Phase 2 and Phase 3), 8. Time to confirmed deterioration (TTCD) in patient-reported physical functioning and global health status/quality of life (GHS/QoL), as measured by the European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30), and in patient-reported lung cancer symptoms for cough, dyspnea (a multi-item subscale), and chest pain, as measured through the use of the EORTC Quality-of-Life Questionnaire Lung Cancer Module (QLQ-LC13) (Phase 2 and Phase 3), 9. Percentage of Participants with Adverse Events (AEs) (Phase 2 and Phase 3), 10. Frequency of patients’ response of the degree they are troubled with treatment symptoms, as assessed through use of the single-item EORTC IL46 (Phase 2 and Phase 3), 11. Serum concentrations of tiragolumab and atezolizumab (Phase 2 and Phase 3), 12. Percentage of participants with anti-drug antibodies (ADAs) to tiragolumab (Phase 2 and Phase 3), 13. Percentage of participants with ADAs to atezolizumab (Phase 2 and Phase 3)
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Investigator-Assessed Confirmed Objective Response Rate (ORR) (Phase 2), 2. Investigator-Assessed Progression-free survival (PFS) (Phase 2 and Phase 3), 3. Overall survival (Phase 3) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Overall survival (Phase 2), 2. PFS as determined by an independent review facility (IRF) (Phase 3), 3. PFS and OS in patients with PD L1 expression at TC ≥50% and TC ≥1% cut-off, as determined by central testing with Ventana PD-L1 (SP263) assay (Phase 3), 4. PFS at 6 months and 12 months (Phase 3), 5. OS rate at 12 months and 24 months (Phase 3), 6. Confirmed ORR (Phase 3), 7. Duration of response for patients with a confirmed objective response, defined as the time from first occurrence of a confirmed objective response to disease progression or death from any cause (whichever occurs first) (Phase 2 and Phase 3), 8. Time to confirmed deterioration (TTCD) in patient-reported physical functioning and global health status/quality of life (GHS/QoL), as measured by the European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30), and in patient-reported lung cancer symptoms for cough, dyspnea (a multi-item subscale), and chest pain, | — |
Countries
Belgium, Denmark, France, Germany, Poland, Spain