Non-Small Cell Lung Cancer (NSCLC)
Conditions
Brief summary
1. Progression-free survival (PFS), as determined by Blinded independent central review (BICR) per RECIST v1.1
Detailed description
1. PFS, defined as the time from randomization to the first documented disease progression, as determined by the investigator per RECIST v1.1, or death from any cause, whichever occurs first, 2. Time to central nervous system (CNS) progression, as determined by BICR and investigator per RECIST v1.1, 3. Distant metastasis-free survival (DMFS), as determined by BICR and investigator per RECIST v1.1, 4. Objective response rate (ORR), as determined by BICR and investigator per RECIST v1.1, 5. Duration of response (DOR), as determined by BICR and investigator per RECIST v1.1, 6. Overall survival (OS), 7. Time-to-confirmed deterioration (TTCD), in the following patient-reported scales and lung cancer symptoms: Physical functioning, Role functioning, Cough, Chest pain, Dyspnea, 8. Change from baseline score as measured through the use of the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) at 5, 11, and 17 months in the following patient-reported scales and lung cancer symptoms: Physical functioning, Role functioning, Cough, Chest pain, Dyspnea, 9. Incidence, type, and severity of adverse events according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0), 10. Changes in vital signs, physical findings, and clinical laboratory results during and following administration of protocol-specified investigational medicinal products (IMPs)
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Progression-free survival (PFS), as determined by Blinded independent central review (BICR) per RECIST v1.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. PFS, defined as the time from randomization to the first documented disease progression, as determined by the investigator per RECIST v1.1, or death from any cause, whichever occurs first, 2. Time to central nervous system (CNS) progression, as determined by BICR and investigator per RECIST v1.1, 3. Distant metastasis-free survival (DMFS), as determined by BICR and investigator per RECIST v1.1, 4. Objective response rate (ORR), as determined by BICR and investigator per RECIST v1.1, 5. Duration of response (DOR), as determined by BICR and investigator per RECIST v1.1, 6. Overall survival (OS), 7. Time-to-confirmed deterioration (TTCD), in the following patient-reported scales and lung cancer symptoms: Physical functioning, Role functioning, Cough, Chest pain, Dyspnea, 8. Change from baseline score as measured through the use of the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) at 5, 11, and 17 months in the follo | — |
Countries
Belgium, France, Germany, Italy, Netherlands, Norway, Poland, Spain, Sweden