NCT05768490 Early or Delayed Intervention of Brain Radiotherapy Combined With Almonertinib in EGFR Mutated NSCLC With Brain Metastases
| NCT ID | NCT05768490 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Sun Yat-sen University |
| Condition | Brain Metastases |
| Study Type | INTERVENTIONAL |
| Enrollment | 232 participants |
| Start Date | 2023-03-15 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 232 participants in total. It began in 2023-03-15 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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).
Contact & Investigator
Likun Chen
PRINCIPAL INVESTIGATOR
sunyat-sen university cancer center
Frequently Asked Questions
Who can join the NCT05768490 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Brain Metastases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05768490 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 232 participants.
Is NCT05768490 currently recruiting?
Yes, NCT05768490 is actively recruiting participants. Contact the research team at chenlk@sysucc.org.cn for enrollment information.
Where is the NCT05768490 trial being conducted?
This trial is being conducted at Guangdong, China.
Who is sponsoring the NCT05768490 clinical trial?
NCT05768490 is sponsored by Sun Yat-sen University. The principal investigator is Likun Chen at sunyat-sen university cancer center. The trial plans to enroll 232 participants.