Actively Recruiting
High-dose Furmonertinib in the Treatment in Patients With Advanced, Metastatic NSCLC With Progressed After First- or Second-line Treatment With Osimertinib
Led by Changhai Hospital · Updated on 2024-07-26
84
Participants Needed
1
Research Sites
121 weeks
Total Duration
On this page
Sponsors
C
Changhai Hospital
Lead Sponsor
T
The General Hospital of Eastern Theater Command
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
High-dose Furmonertinib in the Treatment in Patients With Advanced, Metastatic NSCLC With Progressed After First- or Second-line Treatment With Osimertinib
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed metastatic lung adenocarcinoma
- Progression of imaging-confirmed extracranial lesions after first- or second-line treatment with Osimertinib
- Previous genetic testing confirming EGFR-sensitive mutation with progression after first-line Osimertinib, or T790M mutation with progression after second-line Osimertinib
- Clinical benefit from prior Osimertinib treatment (complete response, partial response, or stable disease longer than 6 months)
- At least one measurable lesion per RECIST 1.1 criteria
- Normal function of major organs
- Negative pregnancy test within 7 days before first dose for pre-menopausal women of childbearing potential
- Signed written informed consent
You will not qualify if you...
- Previous chemotherapy or immunotherapy
- Non-lung adenocarcinoma lung cancers, including squamous or mixed types
- Progression after Osimertinib with available treatment options after genetic testing
- Symptomatic brain metastases, meningeal metastases, or spinal cord compression
- Unrecovered toxicity greater than grade 1 from prior Osimertinib treatment at study start
- Other malignant tumors within 5 years, except certain controlled cancers
- History of diagnosed interstitial pneumonia
- Any other condition judged by the investigator to make participation unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Changhai Hospital
Shanghai, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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