drugset / Trial / NCT04695925
Osimertinib Monotherapy or Combination With Chemotherapy for Advanced NSCLC Concurrent EGFR and TP53 Mutations
Phase 3
Active not recruiting
294 enrolled
Li Zhang, MD
Cancer Hospital of Guangxi Medical University · collabFirst People's Hospital of Foshan · collabHenan Cancer Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a phase III randomized trial in patients with advanced non-squamous NSCLC harboring EGFR-sensitizing mutations and concurrent TP53 mutations with a performance status of 0 to1 who are planned to receive first-line therapy.
Timeline
- Start
- 2021-03-29
- Primary completion
- 2025-11-01
- Completion
- 2027-12-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carboplatin | Small molecule | 5 unknown | Intravenous |
| Subject | Osimertinib | Small molecule | 80 mg | Oral |
| Subject | Pemetrexed | Small molecule | 500 mg/m2 | Intravenous |