NSCLC (Non-small Cell Lung Cancer)Phase 2HOFIBRENNCT07182708
High-Dose Firmonertinib Plus Bevacizumab as Neoadjuvant Therapy for Resectable EGFRm Stage II-IIIB NSCLC
A Phase 2 study testing Firmonertinib Mesilate Tablets and Bevacizumab injection in people with NSCLC (Non-small Cell Lung Cancer) and EGFR Activating Mutation, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
This is a Phase II, single-arm, open-label, multicenter clinical study aimed at evaluating the efficacy and safety of Firmonertinib 160 mg combined with Bevacizumab as neoadjuvant therapy in patients with resectable stage II-IIIB Epidermal Growth Factor Receptor(EGFR)-mutated non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC (Non-small Cell Lung Cancer), EGFR Activating Mutation, Resectable Lung Non-Small Cell Carcinoma
- What is being tested?
- Firmonertinib Mesilate Tablets and Bevacizumab injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2025to 30 Jun 2030
- 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.
- Histologically/cytologically confirmed primary non-small cell lung cancer within 60 days prior to the study.
- Stage II-IIIB disease evaluated by endobronchial ultrasound guided tranbronchial needle aspiration(EBUS-TBNA), mediastinoscopy, or Positron Emission Tomography/Computed Tomography (PET/CT), with lesions planned for radical resection after neoadjuvant therapy.
- EGFR mutation-positive confirmed by local laboratory testing of tissue or blood samples.
- Presence of at least one measurable lesion, with a baseline Computed Tomography (CT) scan showing the longest diameter ≥10 mm (except for lymph nodes, which must have a short axis ≥15 mm), and suitable for accurate repeated measurements.
- ECOG performance status score of 0-1, with no deterioration within 2 weeks prior to the first dose administration.
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- Female patients should adopt fully effective contraceptive measures, must not be breastfeeding, and have a negative pregnancy test before the first administration of the study drug; or female patients must meet the following criteria at screening to confirm the absence of reproductive potential:
- Postmenopausal, defined as age greater than 50 years and amenorrhea for at least 12 months after cessation of all exogenous hormonal therapies.
- For women under 50 years of age, they are considered postmenopausal if they have not had a menstrual period for 12 months or more after stopping exogenous hormone therapy, and their luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels are within the postmenopausal range.
- Documented irreversible sterilization procedures, including hysterectomy, bilateral oophorectomy, or bilateral salpingectomy, excluding tubal ligation.
- Male patients should be willing to use barrier contraception, i.e., condoms.
Who cannot join
- Presence of small cell lung cancer or mixed pathological types of NSCLC. EGFR exon 20 insertion mutation detected by genetic testing.
- Exposure to any other antitumor therapy prior to enrollment, including perioperative radiotherapy.
- The patient is in pregnancy or lactation.
- History of other malignant tumors, or currently combined with other malignant tumors (except for malignancies that have undergone radical surgery with no recurrence within 5 years post-operation, such as cervical carcinoma in situ, basal cell carcinoma of the skin, and papillary thyroid carcinoma, etc.).
- Presence of severe or uncontrolled systemic diseases requiring treatment, which the investigator deems unsuitable for trial participation, including hypertension, diabetes mellitus, chronic heart failure (New York Heart Association, NYHA Class III-IV), unstable angina, myocardial infarction within the past year, etc.
- Severe gastrointestinal dysfunction, diseases, or clinical conditions that may affect the intake, transport, or absorption of the study drug, such as inability to take oral medications, uncontrollable nausea and vomiting, extensive gastrointestinal resection history, etc.
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- Any of the following laboratory tests indicate insufficient bone marrow reserve or organ reserve function.
- Absolute neutrophil count <1.5×10^9/L
- Platelet count <100×10^9/L
- Hemoglobin <90 g/L
- Alanine aminotransferase (ALT) >2.5×upper limit of normal (ULN)
- Aspartate aminotransferase (AST) >2.5×ULN
- Total bilirubin >1.5×ULN or >3×ULN in cases of Gilbert's syndrome (unconjugated hyperbilirubinemia)
- Known or suspected allergy to almonertinib mesylate, bevacizumab, or any other component of their formulations, or patients with other contraindications.
- If the patient cannot comply with the study procedures, restrictions, and requirements, or if the investigator deems the patient ineligible or unsuitable for participation in the study for any other reason.
- Patients currently or previously enrolled in any other anti-tumor clinical studies.
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
Beijing Cancer Hospital
Beijing, Beijing Municipality
Yan Wanpu Associate consultant, +86 01088196103, yanwanpu@bjmu.edu.cn
About this study
Official title: High-dose Firmonertinib Combined With Bevacizumab as Neoadjuvant Therapy in Stage II-IIIB, Resectable, EGFR-mutated Non-small Cell Lung Cancer Patients: A Single-arm, Multi-center, Open-label Phase II Clinical Study
This is a Phase II, single-arm, open-label, multicenter clinical study aimed at evaluating the efficacy and safety of Firmonertinib 160 mg combined with Bevacizumab as neoadjuvant therapy in patients with resectable stage II-IIIB Epidermal Growth Factor Receptor(EGFR)-mutated non-small cell lung cancer.
- Conditions
- NSCLC (Non-small Cell Lung Cancer), EGFR Activating Mutation, Resectable Lung Non-Small Cell Carcinoma
- Being tested
- Firmonertinib Mesilate Tablets, Bevacizumab injection
- Keywords
- High-dose Firmonertinib, Bevacizumab, Neoadjuvant therapy, NSCLC, EGFR-mutated, Single-arm study
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Firmonertinib Mesilate TabletsDrug
Firmonertinib Mesilate Oral administration 160 mg once daily for 3 months before surgery. Radical tumor resection will be performed at least 6 weeks after completion of Bevacizumab treatment. After surgery, the treatment plan was determined by the researchers, with options including Firmonertinib Mesilate Tablets: Oral administration once daily, 80mg per dose, for 3 years or until disease progression or intolerable toxicity occurs.
Bevacizumab injectionDrug
Bevacizumab injection (intravenous infusion, 7.5 mg/kg) administered every 21 days as one cycle, for a total of 2 cycles. Radical tumor resection will be performed at least 6 weeks after completion of Bevacizumab treatment.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant therapy | Experimental | Not described Receives: Drug: Firmonertinib Mesilate Tablets; Drug: Bevacizumab injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathological Complete Response(pCR) rate
Defined as the proportion of patients with no residual viable tumor cells in the primary lesion, as assessed by central laboratory pathologists after surgical resection.
Measured: Within 24 hours after surgical resection
Secondary outcomes (9)
Major pathological response (MPR) rate
Defined as the proportion of patients with ≤10% viable tumor cells in the primary lesion of the surgically resected specimen as assessed by central laboratory pathologists.
Measured: Within 7 days after surgical resection
Radical resection rate
Defined as the proportion of patients who successfully underwent R0 resection among enrolled patients
Measured: Within 7 days after surgical resection
Lymph node downstaging rate
Defined as the proportion of patients whose lymph node staging was downgraded after neoadjuvant therapy and surgical treatment, as confirmed by pathological assessment.
Measured: Within 7 days after completion of neoadjuvant therapy and within 7 days after surgical resection
Pathological positive lymph node conversion rate
Defined as the proportion of pathologically positive lymph nodes that convert to negative after neoadjuvant therapy, as assessed by pathologists.
Measured: Within 7 days after completion of neoadjuvant therapy and within 7 days after surgical resection
Objective response rate (ORR) by investigator
Defined as the proportion of patients who achieved complete response or partial response after 9 weeks following the first dose of Firmonertinib, as assessed by investigator using Computed Tomography (CT) scans according to RECIST 1.1 criteria.
Measured: Approximately 9 weeks following the first dose of Firmonertinib
Event-free survival (EFS)
Defined as the time from the first administration of study treatment to the occurrence of an event or death, whichever occurs first. Events include documented disease progression that prevents surgery or necessitates non-protocol-specified treatment; local or distant disease recurrence or new lesions (pathologically confirmed new primary malignancies are not considered EFS events).
Measured: From first dose until the event of interest, assessed up to 36 months after the first dose
Safety: Occurrence and frequency of adverse events, severity, surgical complications
Occurrence and frequency of adverse events, severity, surgical complications
Measured: From randomization to 30 days after treatment completion
Patient-reported outcomes: Change from European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30(EORTC QLQ-C30)
Assessed using EORTC QLQ-C30 to evaluate patient symptoms and overall quality of life.
Unit of Measure: Score on a 0-100 scale Range: 0 = Worst; 100 = Best (Higher score indicates better quality of life)
Measured: Day1/21/42/63/84 of Neoadjuvant Therapy
Patient-reported outcomes: Change from European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 13(QLQ-LC13)
Assessed using EORTC QLQ-LC13 to evaluate patient symptoms and overall quality of life.
Unit of Measure: Score on a 0-100 scale Range: 0 = Worst; 100 = Best (Higher score indicates better quality of life)
Measured: Day1/21/42/63/84 of Neoadjuvant Therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion30 Dec 2029 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC (Non-small Cell Lung Cancer)Studies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe 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
- Model description
- Study participants will receive oral Firmonertinib 160 mg once daily for 3 months before surgery, and Bevacizumab injection administered every 21 days as one cycle, for a total of 2 cycles. Radical tumor resection will be performed at least 6 weeks after completion of Bevacizumab treatment. The investigator will determine the postoperative adjuvant treatment regimen, with options including Firmonertinib Mesilate Tablets: Oral administration once daily, 80mg per dose, for 3 years or until disease progression or intolerable toxicity occurs.
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wanpu Yan, MD, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07182708
- Sponsor's protocol ID
- LGH2025343
- Acronym
- HOFIBREN
- Status last verified
- Sep 2025
- First submitted
- 5 Sep 2025
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not applicable. No individual participant data will be made available. Aggregate results will be reported in publications and on ClinicalTrials.gov; general inquiries may be directed to the corresponding author, but IPD will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-dose Firmonertinib Combined With Bevacizumab as Neoadjuvant Therapy in Stage II-IIIB, Resectable, EGFR-mutated Non-small Cell Lung Cancer Patients: A Single-arm, Multi-center, Open-label Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT07182708
- Acronym / sponsor ID
- HOFIBREN / LGH2025343
- Conditions
- NSCLC (Non-small Cell Lung Cancer), EGFR Activating Mutation, Resectable Lung Non-Small Cell Carcinoma
- Keywords
- High-dose Firmonertinib, Bevacizumab, Neoadjuvant therapy, NSCLC, EGFR-mutated, Single-arm study
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 30 Dec 2029 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 19 Sep 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.
This is a Phase II, single-arm, open-label, multicenter clinical study aimed at evaluating the efficacy and safety of Firmonertinib 160 mg combined with Bevacizumab as neoadjuvant therapy in patients with resectable stage II-IIIB Epidermal Growth Factor Receptor(EGFR)-mutated non-small cell lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Study participants will receive oral Firmonertinib 160 mg once daily for 3 months before surgery, and Bevacizumab injection administered every 21 days as one cycle, for a total of 2 cycles. Radical tumor resection will be performed at least 6 weeks after completion of Bevacizumab treatment. The investigator will determine the postoperative adjuvant treatment regimen, with options including Firmonertinib Mesilate Tablets: Oral administration once daily, 80mg per dose, for 3 years or until disease progression or intolerable toxicity occurs.
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant therapy | Experimental | Drug: Firmonertinib Mesilate Tablets, Drug: Bevacizumab injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female, aged ≥18 years.
- Histologically/cytologically confirmed primary non-small cell lung cancer within 60 days prior to the study.
- Stage II-IIIB disease evaluated by endobronchial ultrasound guided tranbronchial needle aspiration(EBUS-TBNA), mediastinoscopy, or Positron Emission Tomography/Computed Tomography (PET/CT), with lesions planned for radical resection after neoadjuvant therapy.
- EGFR mutation-positive confirmed by local laboratory testing of tissue or blood samples.
- Presence of at least one measurable lesion, with a baseline Computed Tomography (CT) scan showing the longest diameter ≥10 mm (except for lymph nodes, which must have a short axis ≥15 mm), and suitable for accurate repeated measurements.
Key exclusion criteria (16 listed)
- Presence of small cell lung cancer or mixed pathological types of NSCLC. EGFR exon 20 insertion mutation detected by genetic testing.
- Exposure to any other antitumor therapy prior to enrollment, including perioperative radiotherapy.
- The patient is in pregnancy or lactation.
- History of other malignant tumors, or currently combined with other malignant tumors (except for malignancies that have undergone radical surgery with no recurrence within 5 years post-operation, such as cervical carcinoma in situ, basal cell carcinoma of the skin, and papillary thyroid carcinoma, etc.).
- Presence of severe or uncontrolled systemic diseases requiring treatment, which the investigator deems unsuitable for trial participation, including hypertension, diabetes mellitus, chronic heart failure (New York Heart Association, NYHA Class III-IV), unstable angina, myocardial infarction within the past year, etc.
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 |
|---|---|---|
| Firmonertinib Mesilate TabletsFirmonertinib Mesilate Oral administration 160 mg once daily for 3 months before surgery. Radical tumor resection will be performed at least 6 weeks after completion of Bevacizumab treatment. After surgery, the treatment plan was determined by the researchers, with options including Firmonertinib Mesilate Tablets: Oral administration once daily, 80mg per dose, for 3 years or until disease progression or intolerable toxicity occurs. | Drug | Neoadjuvant therapy |
| Bevacizumab injectionBevacizumab injection (intravenous infusion, 7.5 mg/kg) administered every 21 days as one cycle, for a total of 2 cycles. Radical tumor resection will be performed at least 6 weeks after completion of Bevacizumab treatment. | Drug | Neoadjuvant therapy |
Primary outcome
pathological Complete Response(pCR) rate
Time frame: Within 24 hours after surgical resection
Defined as the proportion of patients with no residual viable tumor cells in the primary lesion, as assessed by central laboratory pathologists after surgical resection.
9 secondary outcomes
Major pathological response (MPR) rate
Time frame: Within 7 days after surgical resection
Radical resection rate
Time frame: Within 7 days after surgical resection
Lymph node downstaging rate
Time frame: Within 7 days after completion of neoadjuvant therapy and within 7 days after surgical resection
Pathological positive lymph node conversion rate
Time frame: Within 7 days after completion of neoadjuvant therapy and within 7 days after surgical resection
Objective response rate (ORR) by investigator
Time frame: Approximately 9 weeks following the first dose of Firmonertinib
Event-free survival (EFS)
Time frame: From first dose until the event of interest, assessed up to 36 months after the first dose
Safety: Occurrence and frequency of adverse events, severity, surgical complications
Time frame: From randomization to 30 days after treatment completion
Patient-reported outcomes: Change from European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30(EORTC QLQ-C30)
Time frame: Day1/21/42/63/84 of Neoadjuvant Therapy
Patient-reported outcomes: Change from European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 13(QLQ-LC13)
Time frame: Day1/21/42/63/84 of Neoadjuvant Therapy
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 19 Sep 2025.
- Individual participant dataSharing planned: No. Not applicable. No individual participant data will be made available. Aggregate results will be reported in publications and on ClinicalTrials.gov; general inquiries may be directed to the corresponding author, but IPD will not be shared.
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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 Firmonertinib Mesilate Tablets and Bevacizumab injection in people with NSCLC (Non-small Cell Lung Cancer) and EGFR Activating Mutation, run by Peking University Cancer Hospital & Institute 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 11 inclusion and 16 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 19 Sep 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 Yan Wanpu Associate Consultant (+86 01088196103, yanwanpu@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pathological Complete Response(pCR) rate (time frame: Within 24 hours after surgical resection). 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 19 Sep 2025.