lung cancer non small cell lung cancer
Conditions
Interventions
Treatment with PDR001 and platinum-doublet chemotherapy (see protocol pages
37-38).
Sponsors
Novartis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Female and male patients * 18 years. * Stage IIIB or stage IV NSCLC or relapsed locally advanced or metastatic NSCLC. See protocol page 42 for more details, incl. criteria for groups A-D. * Patient who received previous neo-adjuvant or adjuvant systemic therapy will be eligible for enrollment only if relapse has occurred more than 12 months from the end of this therapy. * Histologically or cytologically confirmed diagnosis of NSCLC that is EGFR Wild-type, ALK-negative gene changes and ROS1-negative gene changes. See protocol page 42-43 for details. * ECOG performance status 0-1. * At least one measurable lesion assessed by CT and/or MRI according to RECIST 1.1.
Exclusion criteria
Exclusion criteria: * History of severe hypersensitivity reactions to other monoclonal antibodies which in the opinion of the investigator may pose an increased risk of a serious infusion reaction. * History of interstitial lung disease or interstitial pneumonitis. See protocol page 44 for details. * Major surgery in the last 4 weeks. See protocol page 44 for details. * Thoracic radiotherapy to lung fields in the last 4 weeks. More details on radiotherapy: see protocol page 44. * Clinically significant, uncontrolled heart disease and/or recent cardiac event (within 6 months). See protocol page 44-45 for details. * Active, known or suspected autoimmune disease or a documented history of autoimmune disease. See protocol page 45 for details. * A condition requiring chronic systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within the last 7 days. See protocol page 45 for details. * Any live vaccines against infectious diseases within the last 4 weeks. * Pregnancy, lactation, insufficient contraception for females of childbearing potential and males.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose Limiting Toxicities (DLTs). ORR. | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS, Disease control rate (DCR), DOR (Duration of response) and TTR (Time to Response), OS. Adverse events. PK parameters, Antidrug-antibodies. | — |
Countries
Netherlands
Outcome results
None listed