EGF-R Positive Non-Small Cell Lung CancerNCT06352502
An Observational Study of Furmonertinib for EGFR Mutation-positive NSCLC Patients With Brain Metastasis
An observational study of EGF-R Positive Non-Small Cell Lung Cancer and CNS Metastases, run by Tang-Du Hospital at 1 site in China.
Trial summary
EGFR mutation positive advanced NSCLC patients with CNS metastases were associated with poor prognosis. Furmonertinib showed promising CNS efficacy in doses of 80 mg orally once daily or higher in patients with EGFR T790M mutation positive NSCLC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- EGF-R Positive Non-Small Cell Lung Cancer, CNS Metastases
- What is being tested?
- Furmonertinib
- Type of treatment
- Pill or oral medicine
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 28 Jan 2022to 30 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with EGFR 19Del or L858R mutation diagnosed histologically or cytologically and imaging (MR/CT) confirmed untreated brain metastases before Furmonertinib initiation.
Who may be able to join
- at least 18 years of age;
- Histologically or cytologically confirmed metastatic non-squamous Non-Small Cell Lung Cancer (NSCLC);
- Patient with EGFR 19Del or L858R mutation diagnosed histologically or cytologically.( EGFR L858R or Del 19 with/without T790M )
- Imaging (MR/CT) confirmed untreated brain metastases before Furmonertinib initiation;
- Organ function is compatible with oral Furmonertinib therapy (investigator determination based on real-world practice);
- Life expectancy ≥12 weeks before Fumonertinib initiation;
- ECOG PS of 0 to 2;
- Sign the informed consent form.
Who cannot join
- Any Third-Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI) before Furmonertinib initiation;
- Known hypersensitivity to Furmonertinib or its excipient components;
- Simultaneous systemic chemotherapy or WBI;
- The time from the treatment with any other investigational product or its analogue before Furmonertinib initiation does not exceed 5 half-lives of the drug or 14 days, whichever is longer;
- Any evidence of severe or uncontrolled systemic diseases;
- Presence of any disease that may strongly interfere with oral drug absorption; presence of any factor that contributes to QTc prolongation or increased risk of arrhythmia; presence of interstitial pneumonitis.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tangdu Hopspital
Xi’an, Shanxi, 710038
Haichuan Su, PhD, 18629190366, such@fmmu.edu.cn
Jie Min, PhD, 13709202616, minjie1504@163.com
About this study
Official title: Efficacy and Safety of Furmonertinib for Epidermal Growth Factor Receptor (EGFR) Sensitive Mutation Positive Non-Small Cell Lung Cancer (NSCLC) Patients With Brain Metastasis: a Prospective Observational Study
EGFR mutation positive advanced NSCLC patients with CNS metastases were associated with poor prognosis. Furmonertinib showed promising CNS efficacy in doses of 80 mg orally once daily or higher in patients with EGFR T790M mutation positive NSCLC. This study aims to investigate the efficacy and safety of furmonertinib in the treatment of EGFR-sensitive mutation positive NSCLC patients with brain metastasis.
Read the detailed description
This study aims to prospectively observe the efficacy and safety of furmonertinib in the treatment of EGFR-sensitive mutation positive NSCLC patients with brain metastasis and will recruit about 30 patients in China.
Furmonertinib (AST2818) is a brain penetrant third generation EGFR TKI. In preclinical studies, the concentration of furmonertinib and its main active metabolite in the brain was higher than that in the plasma, indicating that furmonertinib had the potential to treat CNS metastases. Furmonertinib showed promising CNS efficacy in doses of 80 mg orally once daily in patients with EGFR T790M mutated NSCLC, the median CNS PFS was 11.6 months and 19.3 months in the 80 mg and 160 mg orally once daily group, and the CNS ORR was 65% and 85% in the 80 mg and 160 mg group.
This study will enroll the EGFR-sensitive mutation positive NSCLC patients with brain metastasis who are treated by furmonertinib, and the efficacy and safety data will be recorded.
- Being tested
- Furmonertinib
- Keywords
- EGFR, NSCLC, Furmonertinib, CNS metastases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FurmonertinibDrug
Also called AST2818
Patients treated with Furmonertinib mesilate tablets orally
| Study group | Role | What they receive |
|---|---|---|
| Furmonertinib group | Patients treated with Furmonertinib Receives: Drug: Furmonertinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intracranial Objective response rate
Per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) using Investigator assessments, is defined as the number (%) of patients with CNS lesion response of Complete Response or Partial Response, will be assessed up to 2 years.
Measured: Data obtained up until progression, or the last evaluable assessment in the absence of progression, will be assessed up to 2 years.
Intracranial Disease Control Rate
The percentage of subjects who have a best CNS lesion response of Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by the Investigator, will be assessed up to 2 years.
Measured: Data obtained up until progression, or the last evaluable assessment in the absence of progression, will be assessed up to 2 years.
Intracranial progression-free survival
Intracranial progression-free survival (PFS) analysis based on investigator assessment and will be assessed up to 3 years.
Measured: Intracranial progression-free survival (PFS) analysis based on investigator assessment and will be assessed up to 3 years.
Secondary outcomes (3)
Progression-free survival
Progression-free survival (PFS) is defined as the time from first dose of Furmonertinib recorded until the date of disease progression based on investigator assessment.
Measured: Progression-free survival (PFS) analysis based on investigator assessment per RECIST 1.1, and will be assessed up to 2 years.
Overall Survival
Overall survival is defined as the time from beginning of furmonertinib treatment until death due to any cause and will be assessed up to 3 years.
Measured: The time from beginning of furmonertinib treatment until death due to any cause and will be assessed up to 3 years.
Safety/Adverse event
Incidence of Adverse Events (AEs): Incidence, severity and seriousness of adverse events, incidence of serious adverse events (SAEs), which usually be graded by CTCAE v5.0 based on current clinical practice.
Measured: From the recorded first dose of Furmonertinib to 4 weeks after the recorded last dose of Furmonertinib
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start28 Jan 2022
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EGF-R Positive Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Tang-Du HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Haichuan Su, PhD, Principal investigator, Tang-Du Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06352502
- Sponsor's protocol ID
- 202112-28
- Status last verified
- Apr 2024
- First submitted
- 7 Mar 2024
- Last updated
- 8 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Furmonertinib for Epidermal Growth Factor Receptor (EGFR) Sensitive Mutation Positive Non-Small Cell Lung Cancer (NSCLC) Patients With Brain Metastasis: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06352502
- Acronym / sponsor ID
- 202112-28
- Keywords
- EGFR, NSCLC, Furmonertinib, CNS metastases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- 28 Jan 2022 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 8 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
EGFR mutation positive advanced NSCLC patients with CNS metastases were associated with poor prognosis. Furmonertinib showed promising CNS efficacy in doses of 80 mg orally once daily or higher in patients with EGFR T790M mutation positive NSCLC. This study aims to investigate the efficacy and safety of furmonertinib in the treatment of EGFR-sensitive mutation positive NSCLC patients with brain metastasis.
Detailed description
This study aims to prospectively observe the efficacy and safety of furmonertinib in the treatment of EGFR-sensitive mutation positive NSCLC patients with brain metastasis and will recruit about 30 patients in China.
Furmonertinib (AST2818) is a brain penetrant third generation EGFR TKI. In preclinical studies, the concentration of furmonertinib and its main active metabolite in the brain was higher than that in the plasma, indicating that furmonertinib had the potential to treat CNS metastases. Furmonertinib showed promising CNS efficacy in doses of 80 mg orally once daily in patients with EGFR T790M mutated NSCLC, the median CNS PFS was 11.6 months and 19.3 months in the 80 mg and 160 mg orally once daily group, and the CNS ORR was 65% and 85% in the 80 mg and 160 mg group.
This study will enroll the EGFR-sensitive mutation positive NSCLC patients with brain metastasis who are treated by furmonertinib, and the efficacy and safety data will be recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Furmonertinib group | – | Drug: FurmonertinibPatients treated with Furmonertinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with EGFR 19Del or L858R mutation diagnosed histologically or cytologically and imaging (MR/CT) confirmed untreated brain metastases before Furmonertinib initiation.
Key inclusion criteria (8 listed)
- at least 18 years of age;
- Histologically or cytologically confirmed metastatic non-squamous Non-Small Cell Lung Cancer (NSCLC);
- Patient with EGFR 19Del or L858R mutation diagnosed histologically or cytologically.( EGFR L858R or Del 19 with/without T790M )
- Imaging (MR/CT) confirmed untreated brain metastases before Furmonertinib initiation;
- Organ function is compatible with oral Furmonertinib therapy (investigator determination based on real-world practice);
Key exclusion criteria (6 listed)
- Any Third-Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI) before Furmonertinib initiation;
- Known hypersensitivity to Furmonertinib or its excipient components;
- Simultaneous systemic chemotherapy or WBI;
- The time from the treatment with any other investigational product or its analogue before Furmonertinib initiation does not exceed 5 half-lives of the drug or 14 days, whichever is longer;
- Any evidence of severe or uncontrolled systemic diseases;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FurmonertinibAlso: AST2818Patients treated with Furmonertinib mesilate tablets orally | Drug | Furmonertinib group |
Primary outcome
Intracranial Objective response rate
Time frame: Data obtained up until progression, or the last evaluable assessment in the absence of progression, will be assessed up to 2 years.
Per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) using Investigator assessments, is defined as the number (%) of patients with CNS lesion response of Complete Response or Partial Response, will be assessed up to 2 years.
Intracranial Disease Control Rate
Time frame: Data obtained up until progression, or the last evaluable assessment in the absence of progression, will be assessed up to 2 years.
The percentage of subjects who have a best CNS lesion response of Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by the Investigator, will be assessed up to 2 years.
Intracranial progression-free survival
Time frame: Intracranial progression-free survival (PFS) analysis based on investigator assessment and will be assessed up to 3 years.
Intracranial progression-free survival (PFS) analysis based on investigator assessment and will be assessed up to 3 years.
3 secondary outcomes
Progression-free survival
Time frame: Progression-free survival (PFS) analysis based on investigator assessment per RECIST 1.1, and will be assessed up to 2 years.
Overall Survival
Time frame: The time from beginning of furmonertinib treatment until death due to any cause and will be assessed up to 3 years.
Safety/Adverse event
Time frame: From the recorded first dose of Furmonertinib to 4 weeks after the recorded last dose of Furmonertinib
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haichuan Su, PhD principal investigator
Tang-Du Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of EGF-R Positive Non-Small Cell Lung Cancer and CNS Metastases, run by Tang-Du Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Haichuan Su, PhD (18629190366, such@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intracranial Objective response rate (time frame: Data obtained up until progression, or the last evaluable assessment in the absence of progression, will be assessed up to 2 years.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2024.