Advanced Non-Squamous Non-Small Cell Lung Cancer
Conditions
Brief summary
Overall Survival (OS)
Detailed description
Safety characterized by type, incidence, severity, timing, seriousness and relationship to study treatment of adverse events, laboratory abnormalities, and number of patients discontinuing study treatment due to an adverse event., Secondary efficacy endpoints: - Objective Response Rate (ORR) as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). - Duration of Response (DOR); - Clinical Benefit Rate (CBR); - Progression-Free Survival (PFS); and - 1-Year Survival Rate., Blood plasma concentrations of MGCD516., Patient reported outcome (PROs): - Lung Cancer Symptom Scale (LCSS); and - European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L).
Interventions
DRUGSitravatinib
DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.
Sponsors
Mirati Therapeutics Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival (OS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety characterized by type, incidence, severity, timing, seriousness and relationship to study treatment of adverse events, laboratory abnormalities, and number of patients discontinuing study treatment due to an adverse event., Secondary efficacy endpoints: - Objective Response Rate (ORR) as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). - Duration of Response (DOR); - Clinical Benefit Rate (CBR); - Progression-Free Survival (PFS); and - 1-Year Survival Rate., Blood plasma concentrations of MGCD516., Patient reported outcome (PROs): - Lung Cancer Symptom Scale (LCSS); and - European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L). | — |
Countries
Italy, Netherlands, Spain
Outcome results
None listed