Non-Small Cell Lung Cancer
Conditions
Brief summary
Phase 2: Objective Response (OR) Assessed by Blinded Independent Central Review (BICR), Phase 3: Progression-Free Survival (PFS) as assessed by BICR
Detailed description
Phase 2 and 3: Overall Survival (OS) as assessed by BICR, Phase 2: PFS as assessed by BICR, Phase 2 and 3: Duration of Response (DoR) as Assessed by the BICR per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, Phase 2 and 3: Disease Control (DC) as Assessed by the BICR per RECIST v1.1, Phase 3: OR Assessed by BICR, Phase 3: Percentage of Participants with Change from Baseline in Physical Functioning as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30), Phase 3: Percentage of Participants with Change from Baseline in Key Lung Cancer Symptoms as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQLC13), Phase 3: Percentage of Participants with Change from Baseline in GHS/QoL as measured by the EORTC QLQ-C30, Phase 3: Percentage of Participants with Change from Baseline in Physical Functioning as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30)
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase 2: Objective Response (OR) Assessed by Blinded Independent Central Review (BICR), Phase 3: Progression-Free Survival (PFS) as assessed by BICR | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase 2 and 3: Overall Survival (OS) as assessed by BICR, Phase 2: PFS as assessed by BICR, Phase 2 and 3: Duration of Response (DoR) as Assessed by the BICR per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, Phase 2 and 3: Disease Control (DC) as Assessed by the BICR per RECIST v1.1, Phase 3: OR Assessed by BICR, Phase 3: Percentage of Participants with Change from Baseline in Physical Functioning as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30), Phase 3: Percentage of Participants with Change from Baseline in Key Lung Cancer Symptoms as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQLC13), Phase 3: Percentage of Participants with Change from Baseline in GHS/QoL as measured by the EORTC QLQ-C30, Phase 3: Percentage of Participants with Change from Baseline in Physical Functioning as Measured by th | — |