Stage IV non small-cell lung cancer
Conditions
Brief summary
Overall Survival (OS) in Participants With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50%
Detailed description
OS in Participants With PD-L1 TPS ≥1%, OS in Participants With PD-L1 TPS 1% to 49%, Progression-Free Survival (PFS) in Participants With PD-L1 TPS ≥1%, PFS in Participants With PD-L1 TPS ≥50%, Objective Response Rate (ORR) in Participants With PD-L1 TPS ≥1%, PFS in Participants With PD-L1 TPS 1% to 49%, ORR in Participants With PD-L1 TPS ≥50%, ORR in Participants With PD-L1 TPS 1% to 49%, Duration of Response (DOR) in Participants With PD-L1 TPS ≥50%, DOR in Participants With PD-L1 TPS 1% to 49%, DOR in Participants With PD-L1 TPS ≥1%, Change from Baseline in Global Health Status/Quality of Life (QoL) (Items 29, 30) Combined Score on the European Organization for Research and Treatment of Cancer QoL Questionnaire-Core 30 (EORTC QLQ-C30) by PD-L1 TPS Subgroup (≥1%, 1%-49%, ≥50%), Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 by PD-L1 TPS Subgroup (≥1%, 1%-49%, ≥50%), Change from Baseline in Role Functioning (Items 6, 7) Combined Score on the EORTC QLQ-C30 by PD-L1 TPS Subgroup (≥1%, 1%-49%, ≥50%), Change from Baseline in Dyspnea Score (Item 8) on the EORTC QLQ-C30 by PD-L1 TPS Subgroup (≥1%, 1%-49%, ≥50%), Change from Baseline in Cough Score (Item 31) on the European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire Module (EORTC QLQ-LC13) by PD-L1 TPS Subgroup (≥1%, 1%-49%, ≥50%), Change from Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 by PD-L1 TPS Subgroup (≥1%, 1%-49%, ≥50%), Time to Deterioration (TTD) in Global Health Status/QoL (Items 29, 30) Combined Score on the EORTC QLQ-C30 by PD-L1 TPS Subgroup (≥1%, 1%-49%, ≥50%), TTD in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 by PD-L1 TPS Subgroup (≥1%, 1%-49%, ≥50%), TTD in Role Functioning (Items 6, 7) Combined Score on the EORTC QLQ-C30 by PD-L1 TPS Subgroup (≥1%, 1%-49%, ≥50%), TTD in Dyspnea Score (Item 8) on the EORTC QLQ-C30 by PD-L1 TPS Subgroup (≥1%, 1%-49%, ≥50%), TTD in Cough Score (Item 31) on the EORTC QLQ-LC13 by PD-L1 TPS Subgroup (≥1%, 1%-49%, ≥50%), TTD in in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 by PD-L1 TPS Subgroup (≥1%, 1%-49%, ≥50%), Number of Participants Who Experienced One or More Adverse Events (AEs), Number of Participants Who Discontinued Study Intervention Due to an Adverse Event (AE)
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival (OS) in Participants With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% | — |
Secondary
| Measure | Time frame |
|---|---|
| OS in Participants With PD-L1 TPS ≥1%, OS in Participants With PD-L1 TPS 1% to 49%, Progression-Free Survival (PFS) in Participants With PD-L1 TPS ≥1%, PFS in Participants With PD-L1 TPS ≥50%, Objective Response Rate (ORR) in Participants With PD-L1 TPS ≥1%, PFS in Participants With PD-L1 TPS 1% to 49%, ORR in Participants With PD-L1 TPS ≥50%, ORR in Participants With PD-L1 TPS 1% to 49%, Duration of Response (DOR) in Participants With PD-L1 TPS ≥50%, DOR in Participants With PD-L1 TPS 1% to 49%, DOR in Participants With PD-L1 TPS ≥1%, Change from Baseline in Global Health Status/Quality of Life (QoL) (Items 29, 30) Combined Score on the European Organization for Research and Treatment of Cancer QoL Questionnaire-Core 30 (EORTC QLQ-C30) by PD-L1 TPS Subgroup (≥1%, 1%-49%, ≥50%), Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 by PD-L1 TPS Subgroup (≥1%, 1%-49%, ≥50%), Change from Baseline in Role Functioning (Items 6, 7) Combined Score on th | — |
Countries
Hungary, Romania