Actively Recruiting
Armatinib Alone or with Stereotactic Body Radiotherapy for Brain Metastases in EGFR-mutated Non-small Cell Lung Cancer
Led by Shanghai Cancer Hospital, China · Updated on 2023-04-05
300
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients with asymptomatic or minimally symptomatic Stage IV non-small cell lung cancer (NSCLC) that has spread to the brain, specifically those with mutations in the EGFR gene. The study aims to evaluate the timing, effectiveness, and safety of radiotherapy combined with or without the drug Almonertinib for brain metastases in these patients. This is a Phase III, randomized, double-blind clinical trial sponsored by Shanghai Cancer Hospital, China. Participants receive treatment with Almonertinib at a dose of 110 mg per day taken orally. Some patients also receive stereotactic body radiotherapy (SBRT) directed at brain lesions, with doses ranging from 27 to 40 Gy over 3 to 5 sessions. One study group receives SBRT concurrently with the start of Almonertinib, another group receives SBRT after imaging shows maximal remission from Almonertinib alone, and a third group receives Almonertinib only. During the study, participants are closely monitored with MRI scans to assess brain lesions and evaluate treatment response. The main outcome measured is intracranial progression-free survival over a 12-month period. Researchers also assess safety and tolerability. The study includes regular check-ups involving physical exams, laboratory tests, and imaging. Participants remain in the trial for a duration sufficient to capture these outcomes and may continue follow-up after treatment completion.
CONDITIONS
Brief Title
Armatinib Alone or in Combination With SRT for Brain Metastases EGFR-mutated Non-small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years inclusive
- Histologically confirmed non-small cell lung cancer (NSCLC) per AJCC 8th edition staging
- Asymptomatic or minimally symptomatic brain metastases responding to stable doses of medication for at least 3 days
- At least one measurable brain lesion on MRI with no more than 10 brain or brainstem metastases
- Presence of EGFR exon 19 deletion or exon 21 (L858R) mutation, alone or with other EGFR mutations
- No prior systemic therapy except neoadjuvant, adjuvant, or chemotherapy within 3 months before study entry
- ECOG performance status of 0 or 1 with stable condition over previous 2 weeks and expected survival of at least 12 weeks
- Adequate blood counts without recent transfusions or erythropoietin use
- Normal coagulation within specified limits, including those on anticoagulation therapy
- Liver function within specified limits based on presence of liver metastases
- Renal function adequate with serum creatinine and urine protein within limits
- Negative pregnancy test for women of childbearing potential within 3 days before first dose
- Males agree to use barrier contraception during study and for 6 months after
- Voluntary written informed consent provided
You will not qualify if you...
- Participation in another interventional study or use of another study drug within 4 weeks before first dose
- Previous palliative intracranial radiation therapy before first dose
- Major surgery or trauma within 4 weeks before first dose or planned during study
- Prior treatment with EGFR tyrosine kinase inhibitors
- NSCLC without EGFR driver mutation or severe allergic reactions to TKIs
- Inability to undergo MRI
- Brain metastases requiring surgical decompression
- Prior solid organ or blood transplant, active severe infections or uncontrolled effusions
- Other malignancies within 5 years except certain treated cancers
- Unresolved toxicity from prior therapies greater than grade 1 except alopecia or grade 2 neuropathy
- Serious or uncontrolled systemic diseases or infections
- Psychiatric illness or substance abuse affecting compliance
- Serious or uncontrolled eye diseases increasing safety risk
- Known HIV infection
- Likely poor compliance with study requirements as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants receive oral Almonertinib daily. Some participants also receive stereotactic body radiotherapy (SBRT) to brain metastases, either on the first day of Almonertinib or after evidence of maximal remission on MRI.
Visits aligned with daily oral treatment and radiotherapy sessions lasting 3 to 5 fractions
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here