drugset / Trial / NCT01998126
Combination Checkpoint Inhibitor Plus Erlotinib or Crizotinib for EGFR or ALK Mutated Stage IV Non-small Cell Lung Cancer
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The goals of the overall study are to evaluate a recommended phase 2 dose and the short and long term toxicities of the combinations. This is a modified phase I trial of immune checkpoint inhibitors in combination with mutation - specific targeted therapy (crizotinib or erlotinib) at conventional doses stratified for presence of ALK (Anaplastic lymphoma kinase) or EGFR (epidermal growth factor receptor) mutation. The goals of the overall study are to evaluate a recommended phase 2 dose and the short and long term toxicities of the combinations.
Timeline
- Start
- 2013-12-02
- Primary completion
- 2017-05-09
- Completion
- 2018-03-29
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Crizotinib | Small molecule | 250 mg | — |
| Subject | Erlotinib | Small molecule | 150 mg | — |
| Subject | Ipilimumab | Monoclonal antibody | 1 mg/kg | — |
| Subject | Ipilimumab | Monoclonal antibody | 3 mg/kg | — |
| Subject | Nivolumab | Monoclonal antibody | 240 mg | — |