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New treatment option for Brain Metastases
Official title Early or Delayed Intervention of Brain Radiotherapy Combined With Almonertinib in EGFR Mutated NSCLC With Brain Metastases
ClinicalTrials.gov ID: NCT05768490
What this study is testing
What is Almonertinib?
Almonertinib is an investigational medicine, being studied as a potential treatment for brain metastases.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Patients with histologically or cytologically confirmed non-small cell lung cancer;
- Initial diagnosis of intracranial oligometastases (no treatment after brain metastases) was defined as brain parenchymal metastases confirmed by MRI...
- EGFR sensitivity mutation (exon19del or exon21 L858R);
- Anti-EGFR-targeting drugs and other TKI drugs have not been used in the past;
- Age 18-75;
See the full eligibility criteria
- Patients with histologically or cytologically confirmed non-small cell lung cancer;
- Initial diagnosis of intracranial oligometastases (no treatment after brain metastases) was defined as brain parenchymal metastases confirmed by MRI, the number of intracranial parenchymal metastases was less than 5...
- EGFR sensitivity mutation (exon19del or exon21 L858R);
- Anti-EGFR-targeting drugs and other TKI drugs have not been used in the past;
- Age 18-75;
- A history (past or concurrent) of malignancies in other sites, excluding curable non-melanoma skin cancer and cervical carcinoma in situ;
- The people had received brain radiotherapy before enrollment;
- Patients whose lung lesions were surgically evaluated as resectable were not included if there was no metastasis in other parts of the body;
- Received EGFR inhibitors (including small molecule or monoclonal antibody therapy) or systematic anti-tumor therapy before treatment;
- Prior patients with interstitial lung disease, drug-induced interstitial disease, radiation pneumonia requiring hormone therapy, or any clinically proven active interstitial lung disease with idiopathic pulmonary...
- Pregnant and lactating patients;
- MRI contraindicated patients;
- Patients who cannot receive oral administration, need intravenous high-energy nutrition, have undergone previous surgery that interferes with absorption, or have active digestive tract ulcers;
- The researchers judged that brain radiotherapy could not be received because of other head and facial diseases;
- Any unstable systemic disease (including active infection, poorly controlled hypertension, unstable angina, congestive heart failure, liver, kidney or metabolic disease).
The study team makes the final eligibility decision.
Where it's taking place
- Guangdong, Guangzhou, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangdong, Guangzhou, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.