drugset / Trial / NCT06394674
High-dose Furmonertinib in the Treatment in Patients With Advanced, Metastatic NSCLC With Progressed After First- or Second-line Treatment With Osimertinib
Phase 2
Recruiting
84 enrolled
Changhai Hospital
Fujian Provincial Hospital · collabSecond Affiliated Hospital of Wannan Medical College · collabShanghai Changzheng Hospital · collabShanghai Chest Hospital · collabThe First Affiliated Hospital of Bengbu Medical University · collabThe First People's Hospital of Changzhou · collabThe General Hospital of Eastern Theater Command · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a prospective, randomised, uncontrolled phase II clinical trial planned to include 84 subjects with metastatic lung adenocarcinoma that had progressed after first- or second-line treatment with Osmertinib, who were randomly assigned to trial group 1 and trial group 2, and were given Furmonertinib 160 mg and 240 mg once/day, orally, respectively, with efficacy evaluated every 6 weeks until disease progression, intolerable toxic side effects, or Subjects voluntarily withdrew informed consent.
Timeline
- Start
- 2024-05-01
- Primary completion
- 2025-06
- Completion
- 2026-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Firmonertinib | Small molecule | 160 mg | Oral |
| Subject | Firmonertinib | Small molecule | 240 mg | Oral |