Adenocarcinoma of Lung Metastatic to BrainPhase 2LungBrain001NCT06483672
Furmonertinib Combined With Anlotinib in Lung Adenocarcinoma Patients With EGFR Mutations and Brain Metastases
A Phase 2 study testing Furmonertinib and Anlotinib in people with Adenocarcinoma of Lung Metastatic to Brain, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences.
Trial summary
The goal of this clinical trial is to learn if furmonertinib plus anlotinib works to treat participants with lung adenocarcinoma with EGFR mutations and brain metastases. It will also learn about the safety of furmonertinib plus anlotinib. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenocarcinoma of Lung Metastatic to Brain
- What is being tested?
- Furmonertinib and Anlotinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- Jul 2024to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Male or Female aged ≥18 years old;
- Histologically or cytopathologically confirmed non-small cell lung cancer (NSCLC) ;
- According to RANO-BM, the subject has at least 1 intracranial measurable lesion;
- Tumor tissue samples or blood samples are confirmed to be EGFR mutations;
- ECOG PS 0-1;
- Life expectancy >12 weeks;
- No prior systemic antitumor therapy for metastatic NSCLC
Who cannot join
- Patients without lung adenocarcinoma, including lung squamous cell carcinoma or mixed histological type, etc;
- Expected to receive other anti-tumor therapy other than the investigational product during the study;
- Having previously received systematic anti-tumor therapy
- Having received the following therapies: (1) Having been irradiated for > 30% bone marrow or a large area within 4 weeks prior to the first dose of investigational product; (2) Having received major surgery within 4 weeks prior to the first dose of investigational product or plan to receive major surgery during the study with exception of the surgical procedures to establish vascular access, biopsy through mediastinoscopy or thoracoscopy; (3) Use of a potent CYP3A4 inhibitor within 7 days prior to the first dose of investigational product or a potent CYP3A4 inducer within 21 days prior to the first dose of investigational product; use of the traditional Chinese medicine or traditional Chinese medicine preparation with tumor indication, or traditional Chinese medicine or traditional Chinese medicine preparation with adjuvant anti-tumor effect within two weeks prior to the first dose of investigational product or expected to be required during the study; (4) Having participated in the clinical trial and received the investigational product or device within 4 weeks or at least 5 half-lives prior to the first dose of investigational product; (5) Having received other anti-tumor drugs within 14 days prior to the first dose of investigational product;
- Having a history of other malignant tumor, or other concurrent malignant tumors;
- The toxicity caused by previous anti-tumor therapy has not recovered to <= CTCAE grade 1 (CTCAE 5.0) (except alopecia, sequelae of previous platinum-related neurotoxicity) ;
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- Previous interstitial lung disease (ILD), drug-induced interstitial lung disease, radiation pneumonitis requiring steroid therapy; or having the clinical manifestations of suspected interstitial lung disease;
- Serious gastrointestinal dysfunction, or disease that may affect the intake, transportation or absorption of investigational product;
- Recently active digestive disease
- The patient is prone to bleeding or has active bleeding; Any bleeding event ≥CTCAE grade 3 within 28 days prior to the first study drug;
- Clinically significant prolonged QT interval or other arrhythmia or clinical status considered by investigators that may increase the risk of prolonged QT interval; for example, QTc > 470 ms on ECG at resting state, complete left bundle branch block, degree III atrioventricular block, congenital long QT syndrome, serious hypokalemia, or current use of drugs that may lead to prolonged QT interval;
- Bone marrow reserve, liver, kidney organs and other functions are insufficient;
- There has been an active venous thrombosis event within the last 6 months;
- Known Active hepatitis B virus , hepatitis C virus (positive HCV Ab) or human immunodeficiency virus (positive HIV antibody) infection;
- Infectious disease requiring intravenous medication;
- Known history of mental disease or drug abuse, and currently having an attack or still taking drugs;
- Known or suspected allergy to Furmonertinib or other components of its preparation;
- Female subjects or female partners of male subjects who are pregnant or lactating, or plan to be pregnant during the study;
- Poor compliance, inability to comply with the study procedures, restriction or requirements;
- Other conditions that are considered by investigators as unsuitable to participate in this study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Furmonertinib Combined With Anlotinib in Lung Adenocarcinoma Patients With EGFR Mutations and Brain Metastases, a Prospective Phase II Single-arm Clinical Study
The goal of this clinical trial is to learn if furmonertinib plus anlotinib works to treat participants with lung adenocarcinoma with EGFR mutations and brain metastases. It will also learn about the safety of furmonertinib plus anlotinib. The main questions it aims to answer are:
- Does furmonertinib plus anlotinib increase the number of participants who has a significant tumor shrinkage?
- What medical problems do participants have when taking furmonertinib plus anlotinib? Researchers will evaluate the safety and efficacy of furmonertinib plus anlotinib.
Read more
Participants will:
- Take furmonertinib(every day) and anlotinib(two weeks on and one week off)
- Visit the clinic once every 3 weeks for checkups and tests.
- Keep a diary of their symptoms.
Read the detailed description
The objective of this study is to explore the effectiveness and safety of furmonertinib and anlotinib as first-line treatment for patients with EGFR mutation and brain metastasis lung adenocarcinoma.
This clinical trial adopts a single-center, prospective, single-arm phase II trial design. Each 3 weeks constitute a treatment cycle until disease progression or intolerance.
After screening, eligible patients will be enrolled in the study. They will receive furmonertinib and anlotinib as first-line treatment. The patients will undergo regular visits, and researchers will collect data on efficacy and safety.
- Being tested
- Furmonertinib, Anlotinib
- Keywords
- Adenocarcinoma of Lung, Brain metastasis, EGFR mutation
- Medical subject headings
- Adenocarcinoma of Lung, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FurmonertinibDrug
Also called AST2818
Furmonertinib 80mg, once daily, orally
AnlotinibDrug
Also called No other intervention names
Anlotinib 12mg, once daily (days 1-14, 21 days per cycle), orally
| Study group | Role | What they receive |
|---|---|---|
| Furmonertinib combine with anlotinib | Experimental | Furmonertinib 80mg, once daily, orally Anlotinib 12mg, once daily (days 1-14, 21 days per cycle), orally Receives: Drug: Furmonertinib; Drug: Anlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central Nervous System Objective Response Rate (CNS ORR)
Proportion of subjects whose CNS tumors are assessed as complete response(CR) or partial response(PR) according to RANO-BM.
Measured: Approximately 12 weeks after the last patient begin study treatment
Secondary outcomes (7)
Objective Response Rate (ORR)
Proportion of subjects whose tumors are assessed as complete response(CR) or partial response(PR) according to RECIST 1.1.
Measured: Approximately 12 weeks after the last patient begin study treatment
Disease Control Rate (DCR)
Proportion of subjects whose tumors are assessed as CR, PR or stable disease (SD) according to RECIST 1.1.
Measured: Approximately 12 weeks after the last patient begin study treatment
Progression Free Survival (PFS)
The time from the first dose of the study drugs to the progression of the disease or death for any reason according to RECIST 1.1
Measured: Approximately 18 months after the first patient begin study treatment
Overall survival (OS)
The time from the first dose of the study drugs to the death for any reason according to RECIST 1.1
Measured: Approximately 24 months after the last patient begin study treatment
Central Nervous System Disease Control Rate (CNS DCR)
Proportion of subjects whose CNS tumors are assessed as CR, PR or stable disease (SD) according to RANO-BM.
Measured: Approximately 12 weeks after the last patient begin study treatment
Central Nervous System Progression Free Survival (PFS)
The time from the first dose of the study drugs to the progression of the CNS disease or death for any reason according to RECIST 1.1
Measured: Approximately 18 months after the first patient begin study treatment
Adverse Events (AEs)
The number of patients with adverse events and the severity according to CTCAE v5.0
Measured: rom the start of study drug to 28 days after the last dose of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study startJul 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma of Lung Metastatic to BrainStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sheng Yang, Doctor, Principal investigator, Cancer Hospital, CAMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06483672
- Sponsor's protocol ID
- 23/469-4212
- Acronym
- LungBrain001
- Status last verified
- Jun 2024
- First submitted
- 23 May 2024
- Last updated
- 3 Jul 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 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Furmonertinib Combined With Anlotinib in Lung Adenocarcinoma Patients With EGFR Mutations and Brain Metastases, a Prospective Phase II Single-arm Clinical Study
- ClinicalTrials.gov ID
- NCT06483672
- Acronym / sponsor ID
- LungBrain001 / 23/469-4212
- Keywords
- Adenocarcinoma of Lung, Brain metastasis, EGFR mutation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- Jul 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 3 Jul 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.
The goal of this clinical trial is to learn if furmonertinib plus anlotinib works to treat participants with lung adenocarcinoma with EGFR mutations and brain metastases. It will also learn about the safety of furmonertinib plus anlotinib. The main questions it aims to answer are:
- Does furmonertinib plus anlotinib increase the number of participants who has a significant tumor shrinkage?
- What medical problems do participants have when taking furmonertinib plus anlotinib? Researchers will evaluate the safety and efficacy of furmonertinib plus anlotinib.
Participants will:
- Take furmonertinib(every day) and anlotinib(two weeks on and one week off)
- Visit the clinic once every 3 weeks for checkups and tests.
- Keep a diary of their symptoms.
Detailed description
The objective of this study is to explore the effectiveness and safety of furmonertinib and anlotinib as first-line treatment for patients with EGFR mutation and brain metastasis lung adenocarcinoma.
This clinical trial adopts a single-center, prospective, single-arm phase II trial design. Each 3 weeks constitute a treatment cycle until disease progression or intolerance.
After screening, eligible patients will be enrolled in the study. They will receive furmonertinib and anlotinib as first-line treatment. The patients will undergo regular visits, and researchers will collect data on efficacy and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Furmonertinib combine with anlotinib | Experimental | Drug: Furmonertinib, Drug: AnlotinibFurmonertinib 80mg, once daily, orally Anlotinib 12mg, once daily (days 1-14, 21 days per cycle), orally |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or Female aged ≥18 years old;
- Histologically or cytopathologically confirmed non-small cell lung cancer (NSCLC) ;
- According to RANO-BM, the subject has at least 1 intracranial measurable lesion;
- Tumor tissue samples or blood samples are confirmed to be EGFR mutations;
- ECOG PS 0-1;
Key exclusion criteria (20 listed)
- Patients without lung adenocarcinoma, including lung squamous cell carcinoma or mixed histological type, etc;
- Expected to receive other anti-tumor therapy other than the investigational product during the study;
- Having previously received systematic anti-tumor therapy
- Having received the following therapies: (1) Having been irradiated for > 30% bone marrow or a large area within 4 weeks prior to the first dose of investigational product; (2) Having received major surgery within 4 weeks prior to the first dose of investigational product or plan to receive major surgery during the study with exception of the surgical procedures to establish vascular access, biopsy through mediastinoscopy or thoracoscopy; (3) Use of a potent CYP3A4 inhibitor within 7 days prior to the first dose of investigational product or a potent CYP3A4 inducer within 21 days prior to the first dose of investigational product; use of the traditional Chinese medicine or traditional Chinese medicine preparation with tumor indication, or traditional Chinese medicine or traditional Chinese medicine preparation with adjuvant anti-tumor effect within two weeks prior to the first dose of investigational product or expected to be required during the study; (4) Having participated in the clinical trial and received the investigational product or device within 4 weeks or at least 5 half-lives prior to the first dose of investigational product; (5) Having received other anti-tumor drugs within 14 days prior to the first dose of investigational product;
- Having a history of other malignant tumor, or other concurrent malignant tumors;
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: AST2818Furmonertinib 80mg, once daily, orally | Drug | Furmonertinib combine with anlotinib |
| AnlotinibAlso: No other intervention namesAnlotinib 12mg, once daily (days 1-14, 21 days per cycle), orally | Drug | Furmonertinib combine with anlotinib |
Primary outcome
Central Nervous System Objective Response Rate (CNS ORR)
Time frame: Approximately 12 weeks after the last patient begin study treatment
Proportion of subjects whose CNS tumors are assessed as complete response(CR) or partial response(PR) according to RANO-BM.
7 secondary outcomes
Objective Response Rate (ORR)
Time frame: Approximately 12 weeks after the last patient begin study treatment
Disease Control Rate (DCR)
Time frame: Approximately 12 weeks after the last patient begin study treatment
Progression Free Survival (PFS)
Time frame: Approximately 18 months after the first patient begin study treatment
Overall survival (OS)
Time frame: Approximately 24 months after the last patient begin study treatment
Central Nervous System Disease Control Rate (CNS DCR)
Time frame: Approximately 12 weeks after the last patient begin study treatment
Central Nervous System Progression Free Survival (PFS)
Time frame: Approximately 18 months after the first patient begin study treatment
Adverse Events (AEs)
Time frame: rom the start of study drug to 28 days after the last dose of study drug
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 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.
Sheng Yang, Doctor principal investigator
Cancer Hospital, CAMS
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Furmonertinib and Anlotinib in people with Adenocarcinoma of Lung Metastatic to Brain, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences.
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 7 inclusion and 20 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: opening soon, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sheng Yang, Doctor (010-87788507, medart@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central Nervous System Objective Response Rate (CNS ORR) (time frame: Approximately 12 weeks after the last patient begin study treatment). 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 3 Jul 2024.