Actively Recruiting
Armatinib Alone or in Combination With SRT for Brain Metastases EGFR-mutated Non-small Cell Lung Cancer
Led by Shanghai Cancer Hospital, China · Updated on 2023-04-05
300
Participants Needed
1
Research Sites
308 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Objective:Patients with asymptomatic or minimally symptomatic Stage IV EGFR-positive NSCLC with baseline intracranial metastases. Aim: To investigate the timing, efficacy and safety of radiotherapy in patients with EGFR positive brain metastases treated with armatinib alone or combined with stereotactic radiotherapy. Method: Almonertinib: specification 55mg/tablet; The dosage is 110 mg / day (2 tablets / day) orally once a day; SBRT: 3-5 doses of 27-40 Gy
CONDITIONS
Official 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 18 to 75 years (inclusive)
- Histologically confirmed non-small cell lung cancer (NSCLC) with staging per AJCC 8th edition
- Asymptomatic or minimally symptomatic brain metastases controlled with stable medication for at least 3 days
- At least one measurable brain metastasis on MRI, with 10 or fewer 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 concurrent chemotherapy for no more than 3 months before study entry
- ECOG physical status of 0 or 1, no worsening in the past 2 weeks, and expected survival of at least 12 weeks
- Adequate blood cell counts including neutrophils, platelets, and hemoglobin without recent transfusion or erythropoietin use
- Normal blood clotting function within specified limits, including if on anticoagulation therapy
- Liver function within specified limits based on bilirubin and liver enzymes, considering liver metastases
- Kidney function with serum creatinine and urine protein within defined normal ranges
- Negative pregnancy test within 3 days before starting study drug for women of childbearing potential
- Male participants must use barrier contraception from screening until 6 months after study treatment
- Willingness to voluntarily participate and provide written informed consent
You will not qualify if you...
- Participation in another interventional clinical trial or use of other study drugs within 4 weeks before starting study drug
- Prior palliative intracranial radiation therapy before study drug
- Major surgery or trauma within 4 weeks before study drug or expected need for major surgery during study
- Previous treatment with EGFR tyrosine kinase inhibitors (EGFR-TKI)
- NSCLC patients without EGFR driver gene mutations or with severe allergic reactions to TKIs
- Inability to undergo MRI examination
- Brain metastases requiring surgical decompression
- History of solid organ or blood transplant, active diverticulitis, abdominal abscess, gastrointestinal obstruction, or uncontrolled pleural or peritoneal effusion
- Other malignancies within 5 years except certain treated early-stage cancers
- Unresolved toxicity from prior therapy above grade 1 (except alopecia and grade 2 neurotoxicity)
- Serious or uncontrolled systemic diseases such as active bleeding or infection
- Known psychiatric illness or substance abuse affecting compliance
- Serious or uncontrolled eye diseases increasing patient risk
- Known HIV infection
- Likely poor compliance with study procedures as judged by the investigator
AI-Screening
AI-Powered Screening
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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
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