Actively Recruiting
Early or Delayed Intervention of Brain Radiotherapy Combined With Almonertinib in EGFR Mutated NSCLC With Brain Metastases
Led by Sun Yat-sen University · Updated on 2023-03-14
232
Participants Needed
1
Research Sites
354 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a prospective, multicenter, randomized, controlled clinical study of NSCLC patients with intracranial oligo-metastatic EGFR-sensitive mutations treated with EGFR-TKI Almonertinib , according to the implementation time of brain radiotherapy. Patients were randomly divided into two groups, experimental group (early intervention group of brain radiotherapy) : the brain radiotherapy started within 1 month of TKI treatment, the brain radiotherapy here specifically refers to stereotactic radiotherapy; Control group (brain radiotherapy late intervention group) : Brain radiotherapy was given within 3 months after brain progression during TKI treatment. The differences in OS,iPFS, PFS, iORR, safety, neurocognitive function and quality of life between the two groups were compared.
CONDITIONS
Official Title
Early or Delayed Intervention of Brain Radiotherapy Combined With Almonertinib in EGFR Mutated NSCLC With Brain Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with confirmed non-small cell lung cancer by tissue or cell analysis
- Diagnosis of intracranial oligometastases with fewer than 5 brain lesions confirmed by MRI
- At least one brain lesion measuring 5 mm or larger and located at least 3 mm away from the optic nerve and brainstem
- Presence of EGFR sensitivity mutation (exon19 deletion or exon21 L858R)
- No prior use of anti-EGFR or other tyrosine kinase inhibitor drugs
- Age between 18 and 75 years
You will not qualify if you...
- History or current diagnosis of other malignancies except curable non-melanoma skin cancer and cervical carcinoma in situ
- Previous brain radiotherapy before enrollment
- Lung tumors that were surgically resectable without metastasis elsewhere
- Prior treatment with EGFR inhibitors or systemic anti-tumor therapy
- History of interstitial lung disease, drug-induced interstitial disease, or radiation pneumonia requiring hormone therapy
- Active interstitial lung disease with idiopathic pulmonary fibrosis seen on CT at baseline
- Pregnancy or breastfeeding
- Contraindications to MRI
- Inability to take oral medications or conditions affecting drug absorption
- Brain radiotherapy not possible due to other head or facial diseases
- Any unstable systemic diseases including active infection, uncontrolled hypertension, unstable angina, heart failure, liver, kidney, or metabolic diseases
AI-Screening
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Trial Site Locations
Total: 1 location
1
Sun-Yat-Sen university
Guangdong, Guangzhou, China, 510000
Actively Recruiting
Research Team
L
Likun Chen, Ph.D
CONTACT
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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