Actively Recruiting
Hippocampus-Protective Radiotherapy Combined With Osimertinib for Symptomatic Brain Metastases in EGFR-Mutated Lung Cancer
Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2026-04-01
74
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
T
Tianjin Medical University Cancer Institute and Hospital
Lead Sponsor
T
Tianjin Chest Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a single-arm, multicenter, open-label, phase Ⅱ exploratory clinical study, which plans to enroll 74 treatment-naive patients with EGFR-sensitive mutations (exon 19 deletion, exon 21 L858R mutation) and symptomatic brain metastases from non-small cell lung cancer (NSCLC). The primary objective is to evaluate the intracranial progression-free survival (iPFS) of hippocampal-sparing whole-brain radiotherapy (PTV: 20Gy/10 fractions) combined with simultaneous integrated boost to brain metastases (PGTV: 40Gy/10 fractions) plus osimertinib (80mg orally once daily). The secondary objectives are to assess efficacy indicators including overall progression-free survival (PFS), intracranial/systemic objective response rate (ORR), as well as safety. The primary endpoint is iPFS, supplemented by secondary endpoints such as PFS, ORR, disease control rate (DCR), overall survival (OS), adverse events (AE) evaluated per NCI-CTCAE v5.0 criteria, and neurocognitive function scores (MMSE/HVLT-R). By optimizing the combined mode of radiotherapy and targeted therapy, this study aims to provide a safer and more effective treatment option for such patients, balancing tumor control and quality of life protection.
CONDITIONS
Official Title
Hippocampus-Protective Radiotherapy Combined With Osimertinib for Symptomatic Brain Metastases in EGFR-Mutated Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed a written informed consent form prior to enrollment
- Aged 18-75 years
- Histopathologically confirmed non-small cell lung adenocarcinoma (NSCLC) with EGFR sensitive mutations (exon 19 deletion or exon 21 L858R mutation)
- Brain metastases confirmed by contrast-enhanced cranial CT/MRI, with 1-10 lesions requiring dose escalation; at least one measurable intracranial lesion 10 mm in diameter
- Distance between metastatic lesions and important cerebral functional areas meets radiotherapy requirements
- At least one measurable extracranial lesion confirmed by contrast-enhanced CT/PET-CT
- Symptomatic brain metastasis
- ECOG performance status score of 0-2
- Expected survival time of at least 12 weeks
- No prior anti-tumor treatment for NSCLC
- Normal vital organ function meeting specific blood, biochemical, coagulation, and cardiac ultrasound criteria
- For women of childbearing potential or non-surgically sterilized patients: use of medically approved contraception during treatment and for 3 months after, negative pregnancy test within 7 days prior to enrollment, and not breastfeeding
- Willingness to comply with study follow-up and procedures
You will not qualify if you...
- Uncontrollable third space effusion (e.g., pleural effusion, ascites) not manageable with interventions
- Multiple factors impairing oral drug administration or absorption (e.g., inability to swallow, gastrointestinal resection, chronic diarrhea, intestinal obstruction)
- Known pregnancy, planning pregnancy, or refusal to use effective contraception if of childbearing potential
- Severe concomitant diseases or judged ineligible by investigator
- Presence of meningeal metastasis
- Participation in other drug clinical trials within 4 weeks prior to enrollment
- Concurrent treatment with other anti-tumor therapies
- History of psychotropic drug abuse, alcoholism, or drug addiction
- Underlying diseases interfering with study drugs (e.g., significant ECG abnormalities, active interstitial lung disease)
- Any other condition considered by the investigator to potentially harm the participant or prevent study compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tianjin Medical University Cancer Institute and Hospital
Tianjin, China
Actively Recruiting
Research Team
P
pang qingsong Chief Physician, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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