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

Primary Purpose

Brain Metastases, Radiotherapy, EGFR Activating Mutation

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
brain radiotherapy
Almonertinib
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Metastases

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Sun-Yat-Sen universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

early intervention group of brain radiotherapy

late intervention group of brain radiotherapy

Arm Description

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

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

Outcomes

Primary Outcome Measures

overall survival
The time from randomization to death from any cause.

Secondary Outcome Measures

intracranial progression free survival
patients were randomized from the time of observation of intracranial disease progression or death from any cause
progression free survival
patients were randomized from the time of observation of systemic disease progression or death from any cause
intracranial objective response rate
proportion of patients with complete or partial response of intracranial lesions

Full Information

First Posted
December 12, 2022
Last Updated
March 13, 2023
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT05768490
Brief Title
Early or Delayed Intervention of Brain Radiotherapy Combined With Almonertinib in EGFR Mutated NSCLC With Brain Metastases
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2023 (Anticipated)
Primary Completion Date
December 31, 2028 (Anticipated)
Study Completion Date
December 31, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Metastases, Radiotherapy, EGFR Activating Mutation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
232 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
early intervention group of brain radiotherapy
Arm Type
Experimental
Arm Description
the brain radiotherapy started within 1 month of almonertinib the brain radiotherapy here specifically refers to stereotactic radiotherapy
Arm Title
late intervention group of brain radiotherapy
Arm Type
Active Comparator
Arm Description
Brain radiotherapy was given within 3 months after brain progression during almonertinib treatment
Intervention Type
Radiation
Intervention Name(s)
brain radiotherapy
Intervention Description
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
Drug
Intervention Name(s)
Almonertinib
Intervention Description
almonertinib po 110mg QD
Primary Outcome Measure Information:
Title
overall survival
Description
The time from randomization to death from any cause.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
intracranial progression free survival
Description
patients were randomized from the time of observation of intracranial disease progression or death from any cause
Time Frame
2 years
Title
progression free survival
Description
patients were randomized from the time of observation of systemic disease progression or death from any cause
Time Frame
2 years
Title
intracranial objective response rate
Description
proportion of patients with complete or partial response of intracranial lesions
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Likun Chen, Ph.D
Phone
+8613798019964
Email
chenlk@sysucc.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Likun Chen
Organizational Affiliation
sunyat-sen university cancer center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun-Yat-Sen university
City
Guangdong
State/Province
Guangzhou
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Likun Chen
Phone
13798019964
Email
chenlk@sysucc.org.cn

12. IPD Sharing Statement

Learn more about this trial

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

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