drugset / Trial / NCT04603807
A Study to Compare the Efficacy and Safety of Entrectinib and Crizotinib in Participants With Advanced or Metastatic ROS1 Non-small Cell Lung Cancer (NSCLC) With and Without Central Nervous System (CNS) Metastases
RandomizedParallel-groupOpen-labelTreatment
Summary
The study will compare the efficacy and safety of entrectinib with crizotinib in participants with advanced or metastatic ROS1 non-small cell lung cancer (NSCLC). The participants will self-administer oral entrectinib or crizotinib as described in the protocol and local prescribing information. Treatments will continue until progressive disease, unacceptable toxicity, death, or withdrawal from the study, whichever occurs first.
Timeline
- Start
- 2021-09-30
- Primary completion
- 2028-06-26
- Completion
- 2028-06-26
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Crizotinib | Small molecule | 250 mg | Oral |
| Subject | Entrectinib | Small molecule | 600 mg | Oral |