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AzTrials

Non-small Cell Lung Cancer (NSCLC)Phase 2Better BrainNCT06728865

Evaluation of the Efficacy and Safety of Befotertinib Combined With Bevacizumab as First-Line Treatment for EGFR-Positive Non-Small Cell Lung Cancer With Brain Metastases: A Single-Arm, Open-Label, Prospective Phase II Clinical Study

A Phase 2 study testing The treatment regimen is Befotertinib combined with Bevacizumab. in people with Non-small Cell Lung Cancer (NSCLC) and EGFR Mutation-Positive Lung Cancer, run by Li-kun Chen at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study evaluates the safety and efficacy of Befotertinib combined with Bevacizumab as a first-line treatment for patients with EGFR mutation-positive advanced non-small cell lung cancer (NSCLC) accompanied by brain or leptomeningeal metastases. Read more about this study

Who is it for?
Ages 15 to 75 years
What is being tested?
The treatment regimen is Befotertinib combined with Bevacizumab.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteChina
Study dates
4 Sep 2024to 1 Feb 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 15 to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Aged 18-75 years. ECOG performance status (PS) score of 0-2. Expected survival time of ≥3 months.
  • Histologically or cytologically confirmed non-squamous non-small cell lung cancer (NSCLC).
  • Baseline evaluation confirming the presence of EGFR-sensitizing mutations (19del/L858R) via first- or second-generation sequencing. Test samples can include archived tumor tissue or fresh tumor tissue collected during screening. If unavailable, pleural effusion, cerebrospinal fluid, or blood samples may be used for testing.
  • Asymptomatic brain metastases or those with controlled intracranial hypertension symptoms following dehydration treatment. Continued medication to maintain stable symptoms at enrollment or during the study is allowed.
  • For patients with parenchymal or leptomeningeal brain metastases, MRI must confirm at least one brain lesion with a diameter ≥5 mm.
  • No prior systemic anti-tumor therapy for locally advanced or metastatic NSCLC. Patients who underwent radical surgery, chemoradiotherapy, or adjuvant therapy (chemotherapy or radiotherapy) for early-stage NSCLC may be included if their disease recurred or metastasized after treatment, provided the interval from the last treatment to initial tumor recurrence exceeds 6 months.
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  • Normal function of major organs, with the following criteria: Hematology (without transfusion or hematopoietic stimulating factors within 14 days): Hemoglobin (HB) ≥ 90 g/L. Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L. Platelets (PLT) ≥ 80 × 10⁹/L. Biochemistry: Total bilirubin (TBIL) < 1.5 × upper limit of normal (ULN). Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 × ULN (if liver metastases are present, ALT and AST < 5 × ULN). Creatinine (Cr) ≤ 1.25 × ULN or creatinine clearance rate (CCr) ≥ 45 mL/min (using the Cockcroft-Gault formula). Proteinuria < 2+ (if baseline proteinuria ≥ 2+, a 24-hour urine protein quantification ≤ 1 g is required). International normalized ratio (INR) ≤ 1.5 and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN. Left ventricular ejection fraction (LVEF) ≥ lower limit of normal (50%) as assessed by Doppler ultrasound.
  • Women of childbearing potential must agree to use effective contraception (e.g., intrauterine devices, oral contraceptives, or condoms) during the study and for 6 months after its completion. Negative serum or urine pregnancy test within 7 days prior to enrollment and non-lactating status are required. Male participants must agree to use contraception during the study and for 6 months afterward.
  • Participants must voluntarily consent to participate in the study, sign an informed consent form, and demonstrate good compliance.

Who cannot join

  • Active Bleeding with Brain and/or Leptomeningeal Metastases
  • Includes therapies with agents such as bevacizumab, endurance, or anlotinib.
  • ≥ Grade 2 toxicity (NCI-CTCAE v4.03) related to prior treatments not resolved at the start of study treatment (excluding alopecia and Grade 2 neurotoxicity caused by platinum agents).
  • Includes uncontrolled nausea/vomiting, inability to swallow, gastrointestinal resection, chronic diarrhea, or intestinal obstruction
  • Prior whole-brain radiotherapy (WBRT). Radiotherapy involving >30% of bone marrow or extensive radiation within 4 weeks before the first dose (palliative radiotherapy for non-brain metastases, such as bone metastases, is exempt).
  • Poorly controlled hypertension (defined as blood pressure ≥160/100 mmHg despite optimal antihypertensive therapy). Cardiac criteria, including: QTcF ≥ 470 msec (average of three ECGs, corrected using Fredericia's formula) at rest. Clinically significant arrhythmias, conduction abnormalities, or ECG changes (e.g., complete left bundle branch block, third-degree AV block, second-degree AV block, PR interval ≥250 msec). Factors increasing risk of QT prolongation or arrhythmias, such as NYHA Class III-IV heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age, or use of QT-prolonging medications. Active or uncontrolled severe infections. Liver disease, including cirrhosis, decompensated liver disease, or chronic active hepatitis. Poorly controlled diabetes (fasting blood glucose >10 mmol/L). Urinalysis showing ≥2+ proteinuria, confirmed by 24-hour urine protein quantification >1.0 g.
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  • Presence of unhealed wounds or fractures.
  • NCI-CTCAE > Grade 1 pulmonary bleeding within 4 weeks before enrollment. NCI-CTCAE > Grade 2 bleeding at other sites within 4 weeks before enrollment. Bleeding tendencies (e.g., active gastrointestinal ulcers) or patients on thrombolytic or anticoagulant therapy (e.g., warfarin, heparin, or similar agents).
  • History of arterial/venous thrombosis within 12 months before enrollment, including stroke (e.g., transient ischemic attack, cerebral hemorrhage, or infarction), deep vein thrombosis, or pulmonary embolism.
  • Clinically significant hemoptysis (>50 mL/day) within 3 months before enrollment. Severe bleeding symptoms or conditions such as gastrointestinal bleeding, bleeding gastric ulcers, stool occult blood ≥2+, or vasculitis.
  • History of interstitial lung disease, drug-induced interstitial lung disease, steroid-requiring radiation pneumonitis, or clinically active interstitial lung disease.
  • History of substance abuse or uncontrolled psychiatric disorders.
  • Poorly controlled pleural or ascitic effusions despite symptomatic treatment, causing Grade ≥2 respiratory syndrome (≥CTCAE Grade 2).
  • Known active infections, including: Active hepatitis B (HBsAg positive and HBV-DNA ≥ 2 × 10³ IU/mL during screening). Hepatitis C (HCV-Ab positive and HCV-RNA positive during screening). Active tuberculosis (evidence of active infection within 1 year). Syphilis (both specific and non-specific antibodies positive). HIV infection (HIV antibody positive). Active infections are not routinely screened unless clinically indicated.
  • Severe diseases or conditions deemed to pose risks to patient safety or impede study completion.
  • Severe diseases or conditions deemed to pose risks to patient safety or impede study completion.
  • Prior allogeneic bone marrow transplantation.
  • Prior allogeneic bone marrow transplantation. 19)Any other condition deemed unsuitable for the study by the investigator. 20)Major surgery within 28 days before the first dose (defined as surgeries requiring at least 3 weeks of recovery before study treatment).

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510000

Other trials in China

About this study

Official title: Evaluation of the Efficacy and Safety of Furmonertinib Combined With Bevacizumab as First-Line Treatment for EGFR-Positive Non-Small Cell Lung Cancer With Brain Metastases: A Single-Arm, Open-Label, Prospective Phase II Clinical Study

This study evaluates the safety and efficacy of Befotertinib combined with Bevacizumab as a first-line treatment for patients with EGFR mutation-positive advanced non-small cell lung cancer (NSCLC) accompanied by brain or leptomeningeal metastases. It is a single-arm, open-label, prospective Phase II clinical trial aiming to explore the potential benefits of this combination therapy in improving intracranial progression-free survival (iPFS) and overall survival (OS). Patients will receive Befotertinib daily and Bevacizumab every three weeks until disease progression, intolerable toxicity, or withdrawal of consent. The study seeks to address the unmet need for effective treatments in this challenging patient population.

Being tested
The treatment regimen is Befotertinib combined with Bevacizumab.
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Brain Neoplasms, Meningeal Carcinomatosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The treatment regimen is Befotertinib combined with Bevacizumab.Drug

    The treatment regimen is Befotertinib combined with Bevacizumab.

Study groups in NCT06728865
Study groupRoleWhat they receive
Befotertinib Combined with Bevacizumab Treatment GroupExperimentalThe treatment regimen is Befotertinib combined with Bevacizumab.
Receives: Drug: The treatment regimen is Befotertinib combined with Bevacizumab.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 12-Month Intracranial Progression-Free Survival Rate Assessed by RECIST 1.1 in Patients with EGFR-Mutant NSCLC and Brain Metastases

    The primary outcome measure is the 12-month intracranial progression-free survival (iPFS) rate, defined as the proportion of patients who remain free from intracranial disease progression or death due to any cause within 12 months from the initiation of treatment. Disease progression is assessed using the RECIST 1.1 criteria based on imaging studies, including enhanced brain MRI. Progression events are confirmed by independent radiological evaluation to ensure consistency and accuracy.

    Measured: 12 months from the initiation of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2024
  2. Study start4 Sep 2024
  3. Primary completion1 Feb 2028 (estimated)
  4. Study completion1 Feb 2028 (estimated)

Resources

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
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06728865
Sponsor's protocol ID
GASTO-10121
Acronym
Better Brain
Status last verified
Oct 2026
First submitted
8 Dec 2024
Last updated
21 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing The treatment regimen is Befotertinib combined with Bevacizumab. in people with Non-small Cell Lung Cancer (NSCLC) and EGFR Mutation-Positive Lung Cancer, run by Li-kun Chen 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 9 inclusion and 18 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: under way, not looking for participants, as of the sponsor's last update on 21 Oct 2026. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

12-Month Intracranial Progression-Free Survival Rate Assessed by RECIST 1.1 in Patients with EGFR-Mutant NSCLC and Brain Metastases (time frame: 12 months from the initiation of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06728865.

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 21 Oct 2026.

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