High-dose Furmonertinib in the Treatment in Patients With Advanced, Metastatic NSCLC With Progressed After First- or Second-line Treatment With Osimertinib
NCT06394674 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 84
Last updated 2024-07-26
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.
Conditions
Interventions
- DRUG
-
Furmonertinib
Drug: Furmonertinib
Sponsors & Collaborators
-
The General Hospital of Eastern Theater Command
collaborator OTHER -
Shanghai Chest Hospital
collaborator OTHER -
Fujian Provincial Hospital
collaborator OTHER -
Shanghai Changzheng Hospital
collaborator OTHER -
The First Affiliated Hospital of Bengbu Medical University
collaborator OTHER -
The First People's Hospital of Changzhou
collaborator OTHER -
Second Affiliated Hospital of Wannan Medical College
collaborator OTHER -
Changhai Hospital
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-05-01
- Primary Completion
- 2025-06-30
- Completion
- 2026-09-30
Countries
- China
Study Locations
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