Early or Delayed Intervention of Brain Radiotherapy Combined With Almonertinib in EGFR Mutated NSCLC With Brain Metastases

Launched by SUN YAT-SEN UNIVERSITY · Mar 13, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at how timing affects the treatment of brain metastases in patients with non-small cell lung cancer (NSCLC) who have a specific genetic mutation called EGFR. The study is comparing two groups of patients: one group will receive brain radiotherapy (a targeted form of radiation treatment) within one month of starting a new medication called Almonertinib, while the other group will receive the radiotherapy within three months after their cancer worsens. The goal is to see which timing leads to better outcomes, such as longer survival, improved quality of life, and fewer side effects.

To participate in this trial, patients must be between 18 and 75 years old and have confirmed NSCLC with brain metastases that meet specific criteria. They should not have received previous treatments that target EGFR, and their brain lesions must be suitable for the study. Participants can expect to receive close monitoring throughout the trial to assess their health and how well the treatments are working. This study is currently recruiting participants, and it aims to better understand the most effective way to use radiotherapy alongside Almonertinib for treating brain metastases in this patient population.

Gender

ALL

Eligibility criteria

• Inclusion 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, and the lesions were 3mm away from the optic nerve and brainstem; There must be at least one measurable lesion with a diameter of 5mm or more in the brain.
• • 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;
• Inclusion criteria:
• • A history (past or concurrent) of malignancies in other sites, excluding curable non-melanoma skin cancer and cervical carcinoma in situ;
• • The subjects 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 fibrosis found on CT scan at baseline;
• • 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).