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

NCT ID: NCT05768490

Last Updated: 2023-03-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 232 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-15
• Study Completion Date: 2029-12-31

Brief Summary

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

Brain Metastases; Radiotherapy; EGFR Activating Mutation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

early intervention group of brain radiotherapy

the brain radiotherapy started within 1 month of almonertinib the brain radiotherapy here specifically refers to stereotactic radiotherapy

Group Type: EXPERIMENTAL

brain radiotherapy

Intervention Type: RADIATION

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.

Almonertinib

Intervention Type: DRUG

almonertinib po 110mg QD

late intervention group of brain radiotherapy

Brain radiotherapy was given within 3 months after brain progression during almonertinib treatment

Group Type: ACTIVE_COMPARATOR

Almonertinib

Intervention Type: DRUG

almonertinib po 110mg QD

Interventions

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.

Intervention Type: RADIATION

Almonertinib

almonertinib po 110mg QD

Intervention Type: DRUG

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;

• 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Li-kun Chen

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Likun Chen

Role: PRINCIPAL_INVESTIGATOR

sunyat-sen university cancer center

Locations

Sun-Yat-Sen university

Guangdong, Guangzhou, China

Site Status: RECRUITING

Countries

China

Central Contacts

Likun Chen, Ph.D

Role: CONTACT

chenlk@sysucc.org.cn

+8613798019964

Facility Contacts

Likun Chen

Role: primary

chenlk@sysucc.org.cn

13798019964

Other Identifiers

B2022-428-01

Identifier Type: -

Identifier Source: org_study_id