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

NCT05768490 | Recruiting Phase 3 DMC

• 1 other identifier: B2022-428-01
• Study Type: interventional
• Target: 232
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• overall survival

  The time from randomization to death from any cause.

  3 years

Secondary Outcomes (3)

• intracranial progression free survival

  2 years

• progression free survival

  2 years

• intracranial objective response rate

  6 months

Study Arms (2)

early intervention group of brain radiotherapy

EXPERIMENTAL

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

Radiation: brain radiotherapy; Drug: Almonertinib

late intervention group of brain radiotherapy

ACTIVE COMPARATOR

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

Drug: Almonertinib

Interventions

brain radiotherapy 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.

early intervention group of brain radiotherapy

Almonertinib DRUG

almonertinib po 110mg QD

early intervention group of brain radiotherapy; late intervention group of brain radiotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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, 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).

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun-Yat-Sen university

Guangdong, Guangzhou, 510000, China

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms

Interventions

aumolertinib

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Likun Chen

  sunyat-sen university cancer center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Likun Chen, Ph.D

CONTACT

+8613798019964; chenlk@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: December 12, 2022
• First Posted: March 14, 2023
• Study Start: March 15, 2023
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: March 14, 2023

Record last verified: 2023-03

Locations

CN (1)