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NCT Number: NCT05768490

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sun-Yat-Sen university

Guangdong, Guangzhou, 510000, China

Location status: Recruiting

Location contact

Likun Chen

CONTACT

[email protected]

13798019964

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Almonertinib

Drug

almonertinib po 110mg QD

Primary outcomes

  1. overall survival

    Time frame: 3 years

    The time from randomization to death from any cause.

Secondary outcomes

  1. intracranial progression free survival

    Time frame: 2 years

    patients were randomized from the time of observation of intracranial disease progression or death from any cause

  2. progression free survival

    Time frame: 2 years

    patients were randomized from the time of observation of systemic disease progression or death from any cause

  3. intracranial objective response rate

    Time frame: 6 months

    proportion of patients with complete or partial response of intracranial lesions

Study contacts

Contact information is provided by the study sponsor or research team.

Likun Chen, Ph.D

CONTACT

[email protected]

+8613798019964

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2028
Study completion
2029
First posted
Mar 14, 2023
Registry last updated
Mar 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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