Comparing early and delayed brain radiotherapy with Almonertinib for lung cancer patients with brain metastases

A Prospective, Multicenter, Randomized, Controlled Clinical Study of Early or Delayed Intervention of Brain Radiotherapy Combined With Almonertinib in EGFR Mutated NSCLC With Brain Metastases

This study is testing whether giving brain radiotherapy right away or waiting a bit longer, along with a new lung cancer medication, helps people with brain metastases live longer and feel better.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 232 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sun Yat-sen University (Academic / other)
• Drugs / interventions: radiation, Almonertinib
• Locations: 1 site (Guangdong, Guangzhou)
• Trial ID: NCT05768490 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of early versus delayed brain radiotherapy combined with the EGFR-TKI Almonertinib in patients with non-small cell lung cancer (NSCLC) who have brain metastases. Participants are randomly assigned to receive brain radiotherapy either within one month of starting TKI treatment or within three months after brain progression. The study aims to compare overall survival, progression-free survival, safety, neurocognitive function, and quality of life between the two groups. This multicenter, randomized, controlled trial focuses on patients with specific EGFR mutations and limited brain metastases.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with confirmed EGFR-sensitive mutations and fewer than five brain metastases.

Not a fit: Patients with a history of prior brain radiotherapy or those with resectable lung lesions without metastasis elsewhere may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve treatment outcomes and quality of life for patients with EGFR-mutated NSCLC and brain metastases.

How similar studies have performed: Other studies have shown promising results with similar approaches in treating brain metastases in lung cancer patients, indicating potential for success.

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).

Where this trial is running

Guangdong, Guangzhou

• Sun-Yat-Sen university — Guangdong, Guangzhou, China (Recruiting)

Study contacts

• Principal investigator: Likun Chen — sunyat-sen university cancer center
• Study coordinator: Likun Chen, Ph.D

Conditions Brain Metastases; Radiotherapy; EGFR Activating Mutation