drugset / Trial / NCT04541407
Temodar Plus Tyrosine Kinase Inhibitors for Progressive CNS Disease
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This trial is testing two novel combinations (temozolomide plus osimertinib OR temozolomide plus lorlatinib) which have not been evaluated in clinical trials. Thus, the exact benefits of these novel combinations are unclear. However, based on the mechanism of action of temozolomide and CNS(Central Nervous System) penetration/activity in other tumor types, it is hypothesized that adding temozolomide to osimertinib or temozolomide to lorlatinib may provide improvement in CNS disease control in patients with CNS progression on either of these latter two TKIs (Tyrosine kinase inhibitors).
Timeline
- Start
- 2020-10-29
- Primary completion
- 2022-04-25
- Completion
- 2022-06-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lorlatinib | Small molecule | 100 mg | — |
| Subject | Osimertinib | Small molecule | 80 mg | — |
| Subject | Osimertinib | Small molecule | 160 mg | — |
| Subject | Temozolomide | Small molecule | 200 mg/m2 | Oral |