PFSPhase 2NCT04425187
Bevacizumab Combined With Gefitinib in the Treatment of Advanced NSCLC
A Phase 2 study testing Gefitinib and Bevacizumab Combined With Gefitinib in people with PFS, run by Fudan University at 1 site in China.
Trial summary
To compare the efficacy and safety of gefitinib combined with bevacizumab and gefitinib in the treatment of L858R positive mutation in exon 21 of EGFR gene in advanced NSCLC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PFS
- What is being tested?
- Gefitinib and Bevacizumab Combined With Gefitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 8 Jun 2020to 31 Dec 2022
- Phase
- Phase 2
- 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
Who may be able to join
- Age ≥ 18 years old, gender unlimited.
- NSCLC was confirmed by histology or cytology, and it was evaluated as stage IIIB-IV local advanced, recurrent or metastatic patients who could not be treated surgically. Note: ① the diagnosis result of NSCLC based on sputum cytology needs to be confirmed by immunohistochemistry; ② the current disease should be treated by radiotherapy as the first choice The subjects whose treatment strategy or follow-up target focus judged by the researchers should take radiotherapy as the first treatment strategy should not be selected.
- No systemic anti-tumor therapy was received for locally advanced, recurrent or metastatic NSCLC.
- According to the method of second-generation sequencing, L858R point mutation in exon 21 of EGFR gene was found in primary NSCLC with or without any other coexisting mutations.
- Within 28 days before randomization, at least one measurable lesion was selected according to the RECIST v1.1 standard (see Appendix 1); for the lesions that had previously received radiotherapy, only when there was clear disease progression 3 months after the end of radiotherapy, can they be selected as target lesions.
- ECoG general condition score is 0-1 (see Appendix 2).
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- Expected survival ≥ 12 weeks.
- Patients receiving radiotherapy can be included in the group if they meet the following conditions:
- There was no history of lung disease radiotherapy within 28 days before randomization; L. for radiotherapy outside the chest area, the interval from the end of final radiotherapy to at least 28 days before randomization, and all toxic reactions have recovered.
- Good blood function within 14 days before randomization:
- the absolute neutrophil count (ANC) was ≥ 1.5 × 109 / L (without the support of granulocyte colony stimulating factor) and; L lymphocyte count ≥ 0.5 × 109 / L and; 1. Platelet count ≥ 100 × 109 / L and; Hemoglobin ≥ 9 g / dl (in order to reach this standard, patients can receive blood transfusion).
- 10. Good liver function within 14 days before randomization: L) total bilirubin ≤ 1.5 × upper normal limit (ULN) and;
- 1. Ast, ALT and ALP of patients without liver metastasis were less than 2.5 × ULN; ast, ALT and ALP of patients with liver metastasis were less than 5 × ULN.
- 11. Good renal function within 14 days before randomization:
- 1. Serum creatinine ≤ 1.5 × ULN or calculated creatinine clearance ≥ 45 ml / min and; The urine test paper of urine protein was less than 2 +. If the baseline urine analysis of proteinuria patients is ≥ 2 +, 24-hour urine sample collection must be completed, and 24-hour urine protein ≤ 1 g; serum albumin ≥ 25 g / L.
- 12. Within 14 days before randomization, INR ≤ 1.5 × ULN, APTT ≤ 1.5 × ULN. 13. Heart function meets the requirement of left ventricular ejection fraction (LVEF) ≥ 50%.
- 14. Fertile women: during the treatment period and within 6 months after the last administration, they agreed to abstinence (no heterosexual sexual intercourse) or use contraceptive methods (contraceptive methods with a failure rate of less than 1%). If a postmenopausal woman has not reached the postmenopausal state (menopausal time ≥ 12 months, no other reason except menopause) and has not undergone sterilization (removal of ovaries and / or uterus), she is defined as a woman with fertility.
- 15. Male: for male patients with fertility of female partners or pregnancy of female partners, they agree to abstinence (no heterosexual sexual intercourse) or use condoms within 6 months after the last administration, and agree not to donate sperm.
- 16. Sign the informed consent voluntarily. 17. The researchers judged that they could comply with the research plan.
- -
Who cannot join
- Histology or cytology confirmed mixed adenocarcinoma with squamous cells as the main component (the proportion of squamous cells ≥ 10%).
- There was a history of malignancy (except NSCLC) in the first 5 years before randomization, except for malignancies with negligible risk of metastasis or death (e.g., 5-year OS rate > 90%), such as cervical carcinoma in situ, non melanoma skin cancer, localized prostate cancer, ductal carcinoma in situ or stage I uterine cancer, which were treated appropriately.
- Previous hypertensive crisis, hypertensive encephalopathy, or uncontrolled hypertension (blood pressure: systolic pressure > 150 mmHg and / or diastolic pressure > 100 mmHg).
- The tumor invades the main blood vessels. Researchers or local radiologists must rule out evidence that the tumor is completely adjacent to, surrounding, or extending into the lumen of a major artery, such as the pulmonary artery or superior vena cava.
- Any other disease, neurological or metabolic dysfunction; medical examination or laboratory finding that a disease or condition is suspected, which prohibits the use of the test drug or exposes the patient to a high risk of treatment-related complications.
- It is highly suspected that there are patients with idiopathic pulmonary fibrosis, organic pneumonia, drug-related pneumonia, idiopathic pneumonia, active pneumonia or active tuberculosis.
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- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage (once a month or more frequently) allows patients to retain catheters.
- History of hereditary bleeding constitution or coagulation disorder or other evidence of increased bleeding risk.
- There are non healing wounds, active ulcers or fractures.
- Patients with tracheoesophageal fistula, gastrointestinal perforation or gastrointestinal fistula, and intraperitoneal abscess in the first 6 months were randomly assigned.
- Cardiovascular diseases with clinical significance (such as active), including but not limited to TIA (within 6 months before screening), myocardial infarction (within 6 months before screening), unstable angina, congestive heart failure with New York Heart Association classification ≥ level II (see Appendix 3), and serious arrhythmias beyond the control of drugs.
- Within 3 months before randomization, there was a history of hemoptysis ≥ 2 levels, that is, the blood volume of each bleeding event was > 2.5ml.
- Evidence of central nervous system metastasis, except for patients without any symptoms or patients with symptoms but stable condition, at least 28 days after treatment of central nervous system metastasis.
- Major surgery (including open biopsy) or severe trauma was performed within 28 days prior to randomization, or was expected to be performed during study treatment.
- Severe infections occurring within 28 days prior to randomization, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia.
- 16 aspirin (325 mg / day) or other non steroidal anti-inflammatory drugs known to inhibit platelet function are currently or recently used (within 10 days before bevacizumab was first used).
- 17 full dose oral or parenteral anticoagulants or thrombolytic agents are currently or recently used (within 10 days prior to the first use of bevacizumab). Preventive use of anticoagulants is permitted.
- 18. Core biopsies or other minor operations were performed within 7 days prior to randomization, but vascular access devices were not included. Vascular access devices should be placed at least 2 days before the start of study treatment.
- 19. Those who are known to be allergic to bevacizumab, gefitinib and their excipients, or to Chinese hamster ovarian cell products or other recombinant human or humanized antibodies.
- 20. Those who were confirmed to be HCV positive, HIV positive, syphilis positive, or HBsAg positive during the screening period, and whose HBV DNA titer in the peripheral blood was ≥ 1000 copies / L.
- 21. Pregnancy or lactation, or pregnancy planning during the study. 22. Those who participated in any other clinical trial and took the trial drug treatment within 30 days before randomization.
- 23. The investigator determined that the risk of the subject was greater than any other benefit.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer hospital Fudan University
Shanghai, Shanghai Municipality, 200032
wang jia lei, PD, 18017312689, haitunqiao@hotmail.com
About this study
Official title: Bevacizumab Combined With Gefitinib in the Treatment of Advanced NSCLC Clinical Study of L858R Positive Mutation Patients
To compare the efficacy and safety of gefitinib combined with bevacizumab and gefitinib in the treatment of L858R positive mutation in exon 21 of EGFR gene in advanced NSCLC.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GefitinibDrug
gefitinib 250mg (1 tablet), once a day，PO
Bevacizumab Combined With GefitinibDrug
Bevacizumab Combined With Gefitinib
| Study group | Role | What they receive |
|---|---|---|
| gefitinib | Active comparator | Not described Receives: Drug: Gefitinib |
| gefitinib&bevacizumab | Experimental | Not described Receives: Drug: Bevacizumab Combined With Gefitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
The PFS of gefitinib combined with bevacizumab and gefitinib alone were compared in patients with L858R mutation in exon 21 of EGFR gene in stage IIIB-IV local advanced, recurrent or metastatic NSCLC.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start8 Jun 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PFSStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jialei Wang, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04425187
- Sponsor's protocol ID
- BEVA-FLFX-001
- Status last verified
- Jun 2020
- First submitted
- 8 Jun 2020
- Last updated
- 12 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Zhao X, Wu X, Wang H, Yu H, Sun S, Hu Z, Lin Y, Zhang Y, Yu B, Wu Z, Xiong K, Liu C, Wang S, Bao H, Ou Q, Wang J. Evaluation of gefitinib alone or combined with bevacizumab in patients with EGFR L858R-positive advanced non-squamous non-small cell lung cancer: an open-label, randomized, phase 2 trial (BEVA-FLFX-001) with exploratory analysis of plasma biomarkers. Transl Lung Cancer Res. 2025 Oct 31;14(10):4315-4330. doi: 10.21037/tlcr-2025-545. Epub 2025 Oct 29.
PubMed 41234598
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bevacizumab Combined With Gefitinib in the Treatment of Advanced NSCLC Clinical Study of L858R Positive Mutation Patients
- ClinicalTrials.gov ID
- NCT04425187
- Acronym / sponsor ID
- BEVA-FLFX-001
- Conditions
- PFS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 8 Jun 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 11 Jun 2020 (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.
To compare the efficacy and safety of gefitinib combined with bevacizumab and gefitinib in the treatment of L858R positive mutation in exon 21 of EGFR gene in advanced NSCLC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| gefitinib | Active comparator | Drug: Gefitinib |
| gefitinib&bevacizumab | Experimental | Drug: Bevacizumab Combined With Gefitinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Age ≥ 18 years old, gender unlimited.
- NSCLC was confirmed by histology or cytology, and it was evaluated as stage IIIB-IV local advanced, recurrent or metastatic patients who could not be treated surgically. Note: ① the diagnosis result of NSCLC based on sputum cytology needs to be confirmed by immunohistochemistry; ② the current disease should be treated by radiotherapy as the first choice The subjects whose treatment strategy or follow-up target focus judged by the researchers should take radiotherapy as the first treatment strategy should not be selected.
- No systemic anti-tumor therapy was received for locally advanced, recurrent or metastatic NSCLC.
- According to the method of second-generation sequencing, L858R point mutation in exon 21 of EGFR gene was found in primary NSCLC with or without any other coexisting mutations.
- Within 28 days before randomization, at least one measurable lesion was selected according to the RECIST v1.1 standard (see Appendix 1); for the lesions that had previously received radiotherapy, only when there was clear disease progression 3 months after the end of radiotherapy, can they be selected as target lesions.
Key exclusion criteria (22 listed)
- Histology or cytology confirmed mixed adenocarcinoma with squamous cells as the main component (the proportion of squamous cells ≥ 10%).
- There was a history of malignancy (except NSCLC) in the first 5 years before randomization, except for malignancies with negligible risk of metastasis or death (e.g., 5-year OS rate > 90%), such as cervical carcinoma in situ, non melanoma skin cancer, localized prostate cancer, ductal carcinoma in situ or stage I uterine cancer, which were treated appropriately.
- Previous hypertensive crisis, hypertensive encephalopathy, or uncontrolled hypertension (blood pressure: systolic pressure > 150 mmHg and / or diastolic pressure > 100 mmHg).
- The tumor invades the main blood vessels. Researchers or local radiologists must rule out evidence that the tumor is completely adjacent to, surrounding, or extending into the lumen of a major artery, such as the pulmonary artery or superior vena cava.
- Any other disease, neurological or metabolic dysfunction; medical examination or laboratory finding that a disease or condition is suspected, which prohibits the use of the test drug or exposes the patient to a high risk of treatment-related complications.
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 |
|---|---|---|
| Gefitinibgefitinib 250mg (1 tablet), once a day，PO | Drug | gefitinib |
| Bevacizumab Combined With GefitinibBevacizumab Combined With Gefitinib | Drug | gefitinib&bevacizumab |
Primary outcome
Progression-free survival (PFS)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18 months
The PFS of gefitinib combined with bevacizumab and gefitinib alone were compared in patients with L858R mutation in exon 21 of EGFR gene in stage IIIB-IV local advanced, recurrent or metastatic NSCLC.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2020.
- Derived from this study: PubMed 41234598Zhao X, Wu X, Wang H, Yu H, Sun S, Hu Z, Lin Y, Zhang Y, Yu B, Wu Z, Xiong K, Liu C, Wang S, Bao H, Ou Q, Wang J. Evaluation of gefitinib alone or combined with bevacizumab in patients with EGFR L858R-positive advanced non-squamous non-small cell lung cancer: an open-label, randomized, phase 2 trial (BEVA-FLFX-001) with exploratory analysis of plasma biomarkers. Transl Lung Cancer Res. 2025 Oct 31;14(10):4315-4330. doi: 10.21037/tlcr-2025-545. Epub 2025 Oct 29.
- Individual participant dataSharing planned: Yes
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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.
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 Gefitinib and Bevacizumab Combined With Gefitinib in people with PFS, run by Fudan University 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 20 inclusion and 22 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 12 Jun 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact wang jia lei, doctor (18017312369, haitunqiao@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18 months). 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 NCT04425187, which also lists 1 linked publication.
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 12 Jun 2020.