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High-dose Furmonertinib Versus Osimertinib in Advanced EGFRm NSCLC Patients With Brain Metastases | Clinical Trials | Clareo Health

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High-dose Furmonertinib Versus Osimertinib in Advanced EGFRm NSCLC Patients With Brain Metastases

High-dose Furmonertinib Versus Osimertinib as First-line Treatment in Advanced EGFR Mutation-positive NSCLC Patients With Brain Metastases: a Multi-center, Randomized, Controlled, Prospective, Phase II Clinical Trial

NCT06319950•Taizhou Hospital

View on ClinicalTrials.gov

Summary

The investigators were to explore whether high-dose Furmonertinib, compared with osimertinib, could achieve longer survival in patients with EGFR-mutated NSCLC with CNS metastasis.

Detailed Description

Lung cancer is the leading cause of cancer incidence and death worldwide. Non-small cell lung cancer accounts for about 80-85%, and EGFR mutations occur in about 45-55% of the Asian population. In newly diagnosed NSCLC patients, the rate of brain metastases in advanced NSCLC can be as high as 25% to 44%. The brain metastasis rate of advanced lung adenocarcinoma with EGFR mutation can reach 60%. For NSCLC patients with CNS metastases and EGFR mutations, the PFS of EGFR-TKIs was improved compared with chemotherapy, but neither was satisfactory, even with Osimertinib (third-generation EGFR-TKI). The PFS of patients with CNS metastases treated with Osimertinib was only 15.23 months. Therefore, the diagnosis and treatment of lung cancer patients with brain metastases is still a difficult problem to improve the long-term survival rate of lung cancer. Clinical data and early preclinical studies have shown that Furmonertinib(AST2818) can effectively inhibit the classical mutation of EGFR, especially for intracranial lesions, and is well tolerated. In the FURLONG study, the PFS of patients with CNS metastases was 20.8 months and the ORR were 91%, respectively. This may be due to the unique molecular structure of Furmonertinib, which has the advantage of "double entry into the brain". Furthermore, the investigators' previous research showed that patients treated with 160mg of Furmonertinib after third-generation EGFR-TKIs treatment resistance were divided into intracranial progression mode group and extracranial progression mode group, and finally proven that Furmonertinib 160mg with or without antiangiogenic agents could be an option for patients with advanced NSCLC who have developed resistance after third-generation EGFR-TKIs, especially those who have developed resistance due to intracranial lesion progression. Based on above, the investigators propose to develop a multi-center, randomized, controlled, prospective, Phase II clinical trial in order to explore whether high-dose Furmonertinib could achieve longer survival in patients with EGFR-mutated NSCLC with CNS metastasis, particularly long-term control of intracranial lesions.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female subjects aged \>=18 and \<=80 years old.
•Patients with histologically or cytologically confirmed NSCLC with adenocarcinoma or adenocarcinoma components predominant, and with central nervous system metastases (with measurable lesions).
•The tissue or blood sample is determined to be EGFR positive (including rare EGFR mutations) by testing by a tertiary Class A hospital or a qualified testing institution, and the tissue submitted for testing cannot be from a tumor lesion that has been treated with radiation, but can be used for a new lesion after local treatment.
•Patients who had not previously received systemic anti-tumor therapy for locally advanced or metastatic non-small cell lung cancer (patients who had received first-line chemotherapy but had not received TKIs could be enrolled). Patients who have undergone radical surgery, radical chemo-radiotherapy, or adjuvant therapy (chemotherapy, radiation) for early NSCLC may be enrolled if they later develop disease recurrence or metastasis.
•Stable brain metastases that do not require local treatment of brain metastases either immediately or planned during the study period.
•According to RECIST v1.1, enrolled patients should have at least one tumor lesion in all tumors that can meet the following requirements: they have not been treated with local therapy such as radiotherapy in the past, and can be accurately measured at baseline, and the longest diameter at baseline is ≥10mm (in the case of lymph nodes, the short diameter is ≥15mm). Lesions that have previously received local treatment (radiotherapy or other treatment) can only be measured if disease progression occurs more than 6 months after the end of treatment.
•ECOG PS 0-1, and with no deterioration during the first 2 weeks of the study and expected survival time of no less than 3 months.
•Patients should have sufficient bone marrow reserve function, and no liver, kidney, coagulation dysfunction, laboratory test values must meet the following conditions:
•1. Absolute neutrophil count ≥ 1.5×109/L, and white blood cell count ≥3×109/L;
•2. PLT ≥100×109/L;
+9 more criteria

Exclusion Criteria

•Patients with the following treatments:
•1. Previous use of any EGFR TKIs therapy;
•2. Previously received systemic antitumor therapy (such as targeted therapy, biotherapy, immunotherapy, etc.) for advanced/metastatic non-small cell lung cancer;
•3. Standard chemotherapy within 28 days before the first administration of the study drug; The study received anti-tumor therapy with traditional Chinese medicine within 7 days before the first administration of the drug;
•4. Previous WBRT; Had received \>30% of bone marrow radiotherapy or extensive radiotherapy within 28 days prior to the first dose of the study drug; Local radiotherapy (e.g., thoracic and rib radiotherapy) or palliative radiotherapy for bone metastases within 7 days prior to initial administration of the study drug;
•5. Uncontrolled pleuroperitoneal effusion and pericardial effusion;
•6. Uncontrollable cancerous pain; Anesthetic painkillers did not reach a stable dose at the time of enrollment;
•7. Study major surgery within 28 days before the first administration of the drug ( major surgery refers to grade 3 and grade 4 surgery in Measures for the Clinical Application of Medical Technology in China, on May 1, 2009 );
•8. Has received a strong inducer or suppressor of CYP3A4 within 14 days prior to initial administration of the investigatory drug or requires continued treatment during the study period (including Chinese herbal medicine, see Appendix for a list of drugs);
•9. Patients who are receiving and require continued treatment during the study with drugs known to prolong the QTc interval or that may cause tip torsion ventricular tachycardia (see Appendix for a list of drugs);
+22 more criteria

Key Dates

Start Date

April 1, 2024

Primary Completion Date

December 30, 2026

Completion Date

December 30, 2026

Last Updated

March 20, 2024

Enrollment

255

ESTIMATED participants

Conditions

Lung Cancer, Nonsmall Cell

Interventions

Furmonertinib

DRUG

Osimertinib

DRUG

Contacts

Dongqing Lyu, MD

CONTACT

13867622009 lvdq@enzemed.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 20, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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High-dose Furmonertinib Versus Osimertinib in Advanced EGFRm NSCLC Patients With Brain Metastases

Inclusion Criteria

Exclusion Criteria

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