drugset / Trial / NCT05186506
A Study Comparing Ensatinib Versus Platinum-Based Chemotherapy as Adjuvant Treatment for Stage II-IIIA ALK -Positive Non-Small Cell Lung Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
This randomized, active-controlled, multicenter, open-label, Phase II study is designed to evaluate the efficacy and safety of ensatinib compared with Platinum-Based Chemotherapy as adjuvant treatment in ALK fusion positive II-IIIA stage non-small cell lung cancer after surgical resection
Timeline
- Start
- 2022-01-01
- Primary completion
- 2025-12-15
- Completion
- 2028-12-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Carboplatin | Small molecule | 5 unknown | Intravenous |
| Comparator | Cisplatin | Other / unclassified | 75 mg/m2 | — |
| Subject | Ensartinib | Small molecule | 225 mg | Oral |
| Comparator | Paclitaxel | Small molecule | 175 mg/m2 | — |
| Comparator | Pemetrexed | Small molecule | 500 mg/m2 | — |