NSCLCPhase 2NCT06945705
A Clinical Trial of Furmonertinib Combined With Anlotinib as First-line Treatment for Advanced NSCLC With EGFR-sensitive Mutations and Brain Metastasis
A Phase 2 study testing furmonertinib combined with anlotinib in people with NSCLC, run by Henan Cancer Hospital at 1 site in China.
Trial summary
EGFR mutation-positive NSCLC patients have a higher risk of developing brain metastases. The prognosis is poor for patients presenting with brain or leptomeningeal metastases at any stage, particularly those with such metastases at initial diagnosis, who have the worst prognosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC
- What is being tested?
- furmonertinib combined with anlotinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteChina
- Study dates
- 2 Apr 2025to 2 Oct 2028
- 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
- Patient must meet all of the following inclusion criteria to be enrolled in this study:
- Patients must voluntarily agree to participate in the study and sign a written informed consent form.
- Patients must be ≥18 years old, regardless of gender.
- Patients must have histologically or cytologically confirmed advanced NSCLC, staged as AJCC TNM 9th edition Stage IV.
- Histological or cytological report issued by a hospital or a third-party testing institution recognized by the national assessment confirmed the presence of EGFR 19Del or L858R mutations, with or without other EGFR mutations.
- Patients must have an ECOG performance status score of 0-2 and be expected to survive for at least 12 weeks, as determined by the investigator.
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- Patients must have brain parenchymal metastases confirmed by CT or MRI scans, with or without symptoms (as judged by the investigator).
- Patients must have at least one measurable lesion based on RECIST 1.1 criteria.
- Patients must not have received prior systemic anticancer therapy for advanced/metastatic NSCLC, including standard chemotherapy, biological therapy, targeted therapy, immunotherapy, or investigational drug therapy. Patients who received adjuvant or neoadjuvant therapy (chemotherapy and/or radiotherapy) are eligible if there has been no disease progression within 6 months of treatment completion. Patients who received local therapy (radiotherapy or pleural perfusion therapy) are also eligible if the treated lesion is not a target lesion.
- Patients must meet the following organ function criteria:
- Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L. Platelet count ≥75 × 10⁹/L. Hemoglobin (HGB) ≥80 g/L. Serum total bilirubin (TBIL) ≤1.5 times the upper limit of normal (ULN). For patients with liver metastases, TBIL may be up to 3 times ULN. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 times ULN.
- For patients with liver metastases, AST and ALT may be up to 5 times ULN. Serum creatinine (SCr) ≤1.5 times ULN, or creatinine clearance rate ≥50 mL/min (calculated using the Cockcroft-Gault formula).
- Male patients with reproductive potential and female patients with a possibility of pregnancy must use highly effective contraceptive methods (e.g., oral contraceptives, intrauterine devices, abstinence, or barrier contraception combined with spermicide) during the study and for 12 months after treatment discontinuation.
Who cannot join
- Patients with any of the following criteria are not eligible for enrollment in this study:
- Patients whose diagnosis cannot be confirmed as non-small cell lung cancer (NSCLC) through histological or cytological examination.
- Patients who have leptomeningeal metastasis confirmed by MRI and/or positive cerebrospinal fluid (CSF) cytology, but no evidence of brain parenchymal metastasis.
- Patients who are expected to require other systemic anticancer therapies outside of this study during the trial period.
- Patients with a history of malignancies diagnosed within the past 2 years, excluding well-controlled basal cell carcinoma of the skin, cervical carcinoma in situ, or ductal carcinoma in situ of the breast.
- Patients with significant gastrointestinal diseases that may affect drug intake or absorption, including but not limited to peptic ulcers or inflammatory bowel disease.
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- Patients with known or suspected allergies to the study drugs (furmonertinib and anlotinib) or any components of their formulations.
- Patients who have previously received any epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) therapy.
- Patients who have used strong CYP3A4 inhibitors or inducers within 7 days before the first dose of the study drug or are expected to require long-term use during the trial. Additionally, patients who have used Chinese herbal medicine or formulations with an antitumor indication within 2 weeks before the first dose or are expected to require such use during the trial.
- Patients with a history of interstitial lung disease, drug-induced ILD, or radiation pneumonitis requiring corticosteroid therapy. Patients with acute exacerbation or progressive pulmonary symptoms at baseline, or those deemed unsuitable for enrollment by the investigator due to high-risk factors for ILD, are also excluded.
- Patients with significant arrhythmias (e.g., QT interval >470 ms) or heart failure (left ventricular ejection fraction <50%).
- Pregnant or breastfeeding women.
- Patients who are currently participating in or have participated in other clinical trials within the past 4 weeks.
- Patients with severe acute or chronic medical or psychiatric conditions, as judged by the investigator, that may increase the risks associated with participation in the study or interfere with the interpretation of study results. This also includes patients who are unlikely to complete the study or comply with its requirements due to management-related or other reasons.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Henan Cancer Hospital
Zhengzhou
Fangfang Gao, 13938403632, 21645936@qq.com
About this study
Official title: A Prospective, Single-arm, Multi-center Clinical Trial of Furmonertinib Combined With Anlotinib as First-line Treatment for Advanced NSCLC With EGFR-sensitive Mutations and Brain Metastasis.
EGFR mutation-positive NSCLC patients have a higher risk of developing brain metastases. The prognosis is poor for patients presenting with brain or leptomeningeal metastases at any stage, particularly those with such metastases at initial diagnosis, who have the worst prognosis. Furmonertinib, as a novel EGFR-TKI, enhances its lipophilicity by incorporating a trifluoroethoxy pyridine group. Preclinical animal studies further confirm that both Furmonertinib (AST2818) and its metabolite (AST5902) exhibit excellent intracranial distribution. This provides strong theoretical support for the effective treatment of lung cancer brain metastasis patients with Furmonertinib.
EGFR TKI-based combination therapies, as a strategy to delay disease progression, have consistently been a focal point in medical research. Among these, antiangiogenic agents are increasingly recognized for their synergistic effects when combined with TKIs, jointly inhibiting tumor growth, proliferation, and metastasis.Such combinations have demonstrated clear efficacy and manageable safety profiles.
Based on this, the current study aims to explore the efficacy and safety of first-line treatment with 160 mg Furmonertinib combined with anlotinib for advanced NSCLC patients with EGFR-sensitive mutations and brain metastases.
- Conditions
- NSCLC
- Being tested
- furmonertinib combined with anlotinib
- Keywords
- NSCLC, EGFR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
furmonertinib combined with anlotinibDrug
furmonertinib: 160 mg po qd Anlotinib: 8 mg per day, orally administered.The treatment cycle is every 3 weeks, with each cycle lasting 21 days. Anlotinib are taken on Days 1-14 of each cycle.
| Study group | Role | What they receive |
|---|---|---|
| furmonertinib combined with anlotinib | Experimental | furmonertinib combined with anlotinib Receives: Drug: furmonertinib combined with anlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety（Phase One: Safe Introduction Phase）
When subjects receive ≥3 cycles of investigational treatment or discontinue due to intolerable toxicities, safety analysis will commence. If 2 cases of ≥ Grade 3 TRAEs occur, the study will terminate.
Measured: Up to 6 months
progression-free survival (PFS) (Stage Two: Formal Research Phase）
Measured: Up to 42 months
Secondary outcomes (9)
objective response rate (ORR)(Stage Two: Formal Research Phase）
Measured: Up to 42 months
disease control rate (DCR)(Stage Two: Formal Research Phase）
Measured: Up to 42 months
duration of response（DOR）(Stage Two: Formal Research Phase）
Measured: Up to 42 months
12m-PFS (Stage Two: Formal Research Phase）
Measured: Up to 12 months
18m-PFS(Stage Two: Formal Research Phase）
Measured: Up to 18 months
CNS objective response rate（CNS ORR）(Stage Two: Formal Research Phase）
Measured: Up to 42 months
CNS disease control rate（CNS DCR）(Stage Two: Formal Research Phase）
Measured: Up to 42 months
CNS progression-free survival（CNS PFS）(Stage Two: Formal Research Phase）
Measured: Up to 42 months
Safety（Stage Two: Formal Research Phase）
The occurrence rate and severity of adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE v5.0
Measured: Up to 42 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2025
- Study start2 Apr 2025
- Primary completion2 Sep 2027 (estimated)
- Study completion2 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- More trials run by Henan Cancer 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06945705
- Sponsor's protocol ID
- FAB-HZ001
- Status last verified
- Jan 2025
- First submitted
- 4 Mar 2025
- Last updated
- 25 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-arm, Multi-center Clinical Trial of Furmonertinib Combined With Anlotinib as First-line Treatment for Advanced NSCLC With EGFR-sensitive Mutations and Brain Metastasis.
- ClinicalTrials.gov ID
- NCT06945705
- Acronym / sponsor ID
- FAB-HZ001
- Conditions
- NSCLC
- Keywords
- NSCLC, EGFR
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 2 Apr 2025 (actual)
- Primary completion
- 2 Sep 2027 (estimated)
- Study completion
- 2 Oct 2028 (estimated)
- First posted
- 25 Apr 2025 (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 NSCLC patients have a higher risk of developing brain metastases. The prognosis is poor for patients presenting with brain or leptomeningeal metastases at any stage, particularly those with such metastases at initial diagnosis, who have the worst prognosis. Furmonertinib, as a novel EGFR-TKI, enhances its lipophilicity by incorporating a trifluoroethoxy pyridine group. Preclinical animal studies further confirm that both Furmonertinib (AST2818) and its metabolite (AST5902) exhibit excellent intracranial distribution. This provides strong theoretical support for the effective treatment of lung cancer brain metastasis patients with Furmonertinib.
EGFR TKI-based combination therapies, as a strategy to delay disease progression, have consistently been a focal point in medical research. Among these, antiangiogenic agents are increasingly recognized for their synergistic effects when combined with TKIs, jointly inhibiting tumor growth, proliferation, and metastasis.Such combinations have demonstrated clear efficacy and manageable safety profiles.
Based on this, the current study aims to explore the efficacy and safety of first-line treatment with 160 mg Furmonertinib combined with anlotinib for advanced NSCLC patients with EGFR-sensitive mutations and brain metastases.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| furmonertinib combined with anlotinib | Experimental | Drug: furmonertinib combined with anlotinibfurmonertinib combined with anlotinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patient must meet all of the following inclusion criteria to be enrolled in this study:
- Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L. Platelet count ≥75 × 10⁹/L. Hemoglobin (HGB) ≥80 g/L. Serum total bilirubin (TBIL) ≤1.5 times the upper limit of normal (ULN). For patients with liver metastases, TBIL may be up to 3 times ULN. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 times ULN.
- For patients with liver metastases, AST and ALT may be up to 5 times ULN. Serum creatinine (SCr) ≤1.5 times ULN, or creatinine clearance rate ≥50 mL/min (calculated using the Cockcroft-Gault formula).
Key exclusion criteria (14 listed)
- Patients with any of the following criteria are not eligible for enrollment in this study:
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 |
|---|---|---|
| furmonertinib combined with anlotinibfurmonertinib: 160 mg po qd Anlotinib: 8 mg per day, orally administered.The treatment cycle is every 3 weeks, with each cycle lasting 21 days. Anlotinib are taken on Days 1-14 of each cycle. | Drug | furmonertinib combined with anlotinib |
Primary outcome
Safety（Phase One: Safe Introduction Phase）
Time frame: Up to 6 months
When subjects receive ≥3 cycles of investigational treatment or discontinue due to intolerable toxicities, safety analysis will commence. If 2 cases of ≥ Grade 3 TRAEs occur, the study will terminate.
progression-free survival (PFS) (Stage Two: Formal Research Phase）
Time frame: Up to 42 months
9 secondary outcomes
objective response rate (ORR)(Stage Two: Formal Research Phase）
Time frame: Up to 42 months
disease control rate (DCR)(Stage Two: Formal Research Phase）
Time frame: Up to 42 months
duration of response（DOR）(Stage Two: Formal Research Phase）
Time frame: Up to 42 months
12m-PFS (Stage Two: Formal Research Phase）
Time frame: Up to 12 months
18m-PFS(Stage Two: Formal Research Phase）
Time frame: Up to 18 months
CNS objective response rate（CNS ORR）(Stage Two: Formal Research Phase）
Time frame: Up to 42 months
CNS disease control rate（CNS DCR）(Stage Two: Formal Research Phase）
Time frame: Up to 42 months
CNS progression-free survival（CNS PFS）(Stage Two: Formal Research Phase）
Time frame: Up to 42 months
Safety（Stage Two: Formal Research Phase）
Time frame: Up to 42 months
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 25 Apr 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing furmonertinib combined with anlotinib in people with NSCLC, run by Henan Cancer 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 13 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 25 Apr 2025. 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.
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 Fangfang Gao (13938403632, 21645936@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety（Phase One: Safe Introduction Phase） (time frame: Up to 6 months). The study lists 2 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 25 Apr 2025.