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Non-small Cell Lung Cancer MetastaticBETTERNCT05407155

Bevacizumab Plus Nab-paclitaxel and Platinum for Immunotherapy-treated Non-squamous Non-small Cell Lung Cancer

A study testing bevacizumab plus nab-paclitaxel and platinum in people with Non-small Cell Lung Cancer Metastatic, run by Fudan University 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

Immune checkpoint inhibitor (ICI)-based regimen has been widely used in first-line treatment of driver-gene-negative non-squamous non-small cell lung cancer. This study investigate the efficacy and safety of the combination of bevacizumab plus nab-paclitaxel and platinum as second-line treatment for… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Non-small Cell Lung Cancer Metastatic
What is being tested?
bevacizumab plus nab-paclitaxel and platinum
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 siteChina
Study dates
9 Jun 2022to 30 Aug 2026
Phase
Interventional
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The participants voluntarily signed the informed consent form.
  • The participants should be 18~75 years old.
  • Histology or cytology confirmed, stage IIIB to IV non-small cell lung cancer (according to the eighth edition of the American Joint Committee on cancer AJCC staging) that could not undergo radical treatment.
  • No sensitive EGFR mutation, ALK gene rearrangement and ROS1 gene rearrangement are allowed.
  • Progressed after first-line treatment included immune checkpoint inhibitor (including CTLA-4 monoclonal antibody, PD-1/L1 monoclonal antibody monothrapy or combination therapy, with or without chemotherapy. If the first-line treatment is discontinued due to adverse effects, and patients received no other treatment before disease progression.
  • For patients who have previously received neoadjuvant and/or adjuvant immune checkpoint inhibitor treatment (with or without chemotherapy or radiotherapy) for the purpose of radical treatment of non-metastatic disease, if first-line treatment contained immune checkpoint inhibitors (the same or different immune checkpoint inhibitors with neoadjuvant or adjuvant settings), they can also be included.
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  • At least one measurable lesion according to RECIST criteria v1.1. If patients received radiotherapy, they can be included only when disease progression of the previously irradiated lesion is observed, and the previously irradiated lesion is not the only lesions.
  • ECOG PS score: 0-1.
  • The estimated survival time is more than 3 months.
  • Laboratory test results showed sufficient hematology and end organ functions.
  • Patients with asymptomatic central nervous system (CNS) metastases can be enrolled. Patients with symptomatic CNS metastases should received local treatment and meet the following conditions before enrollment: a) stable for at least 14 days before enrollment with or without receiving steroids and anticonvulsant drugs; b) Complete radiotherapy at least 14 days before enrollment; c) From the end of radiotherapy to the screening phase, no CNS progression was found. If local CNS treatment is performed before enrollment, there should be at least one extracranial measurable lesion according to RECIST criteria v1.1.
  • Women of childbearing age should agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during the study period and within 6 months after the end of the study; Within 7 days before the study, the serum or urine pregnancy test was negative; Non-lactating patients; Men should agree to use contraceptives during the study period and within 6 months after the end of the study period.
  • Ability to follow research and follow-up procedures.

Who cannot join

  • Histologically mixed with small cell or squamous lung cancer.
  • Previously received anti-angiogenic drugs (including bevacizumab, arotinib, apatinib, etc.) and/or paclitaxel (including paclitaxel, paclitaxel liposomes, and nab-paclitaxel). If paclitaxel is used in the adjuvant treatment setting, patients who progressed after 6 months from the last dose of paclitaxel can be included.
  • Patients diagnosed with secondary primary malignant tumor within 5 years before enrollment, except cured cervical carcinoma in situ, superficial bladder tumor [Ta, Tis and T1], basal or squamous cell skin cancer, localized prostate cancer after radical surgery and breast ductal carcinoma in situ after radical surgery.
  • Patients with leptomeningeal metastasis or untreated symptomatic or rapidly progressing CNS metastasis.
  • Unrelieved toxic reactions of CTCAE (5.0) grade 2 or higher caused by any previous treatments, excluding hair loss, nausea and vomiting.
  • For uncontrollable tumor-related pain, patients who need analgesic treatment must have a stable analgesic treatment plan at enrollment. If there are symptomatic lesions suitable for palliative radiotherapy (such as bone metastasis or metastatic nerve invasion), the treatment should be completed before enrollment. The patient should recover from the effects of radiation. For asymptomatic metastatic lesions, if the investigator believes there is the possibility of dysfunction or intractable pain (such as epidural metastasis not currently related to spinal cord compression), local regional treatment should be considered before enrollment.
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  • Major surgery other than that for the purpose of diagnosis was performed within 4 weeks before enrollment, or expected major surgery during the study period.
  • Serious infection within 4 weeks before enrollment, including but not limited to infection, bacteremia or severe pneumonia that leads to hospitalization, or any active infection that the investigator believes may affect the safety of patients.
  • Patients with any severe and / or uncontrolled disease, including:
  • Patients with unsatisfactory blood pressure control (systolic blood pressure > 150 mmHg or diastolic blood pressure > 90 mmHg), hypertensive crisis or hypertensive encephalopathy; (2) Major cardiovascular diseases, including but not limited to: myocardial ischemia or myocardial infarction above grade I, arrhythmia (including QTc ≥ 440ms) and congestive heart failure ≥ grade 2 (NYHA classification); (3) Active or uncontrolled severe infection (≥ CTCAE grade 2 infection); (4) Have a history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation; (5) Uncontrolled pleural effusion, pericardial effusion and peritoneal effusion requiring repeated drainage (once a month or more frequently); (6) Poor control of diabetes [fasting blood glucose (FBG) > 10mmol/l]; (7) Urine routine examination showed that urine protein was ≥++, and the 24-hour urine protein was confirmed to be more than 1.0 G; (8) Patients who have seizures and need treatment; (9) Uncontrolled or symptomatic hypercalcemia (ionic calcium > 1.5 mmol/l, calcium > 12 mg/dl or corrected serum calcium > ULN).
  • 10. Arteriovenous thrombosis events, such as cerebrovascular accident (including transient ischemic attack), deep venous thrombosis and pulmonary embolism within 6 months before enrollment.
  • 11. Hemoptysis ≥ grade 2 (defined as ≥ 2.5 ml of bright red blood each time) within 3 months before enrollment.
  • 12. Bleeding tendencies or coagulation disorders (i.e. without the use of therapeutic anticoagulants).
  • 13. Tumor infiltration or adjacency to large blood vessels. 14. A history of abdominal fistula, gastrointestinal (GI) perforation, abdominal abscess, or active gastrointestinal bleeding within 6 months before enrollment.
  • 15. Aspirin (> 325 mg/d) or clopidogrel (> 75 mg/d) was used currently or recently (10 days before starting the study treatment). The preventive use of anticoagulants is permitted.
  • 16. Active pulmonary tuberculosis (TB) or subjects with a history of active TB infection within ≤ 48 weeks before enrollment, whether treated or not.
  • 17. Have a history of idiopathic pulmonary fibrosis, organized pneumonia (such as bronchiolitis obliterans), drug-induced pneumonia, radiation pneumonia requiring steroid treatment or active pneumonia with clinical symptoms; Or other moderate or severe lung diseases that seriously affect lung function.
  • 18. Has a history of psychotropic substance abuse and is unable to quit or has mental disorders.
  • 19. Known history of allergic or hypersensitive to any component of carboplatin / cisplatin or bevacizumab, and there are no other alternative drugs allowed by this protocol. Patients who are known to be allergic to paclitaxel can be enrolled if clinicians decide that nab-paclitaxel could be used.
  • 20. Pregnant or lactating women. 21. According to the judgment of the investigator, there are concomitant diseases that seriously endanger the safety of the patient or affect the completion of the study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Cancer hospital Fudan University

    Shanghai, Shanghai Municipality, 200032

Other trials in China

About this study

Official title: BEvacizumab Plus Nab-pacliTaxel and plaTinum as sEcond-line theRapy for Driver-gene-negative Non-squamous Non-small Cell Lung Cancer Progressed After First-line Immune Checkpoint Inhibitor-based Regimen

Immune checkpoint inhibitor (ICI)-based regimen has been widely used in first-line treatment of driver-gene-negative non-squamous non-small cell lung cancer. This study investigate the efficacy and safety of the combination of bevacizumab plus nab-paclitaxel and platinum as second-line treatment for driver-gene-negative non-squamous non-small cell lung cancer patients progressed after ICI-based treatments.

Being tested
bevacizumab plus nab-paclitaxel and platinum

What participants receive

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

  • bevacizumab plus nab-paclitaxel and platinumCombination product

    Bevacizumab is given as 15mg/kg every 3 weeks. Nab-paclitaxel is given as 260 mg/m2 every 3 weeks for 4 cycles at most. Platinum includes caboplatin or cisplatin, which is chosed by phycisians. Carboplatin was calculated using AUC equals 5 for 4 cycles at most, and cisplatin was given as 75mg/m2 for 4 cycles at most. Bevacizumab is given untill disease progression or intolerated toxicities.

Study groups in NCT05407155
Study groupRoleWhat they receive
Experimental armExperimentalPatients received bevacizumab plus nab-paclitaxel and platinum as second-line therapy.
Receives: Combination Product: bevacizumab plus nab-paclitaxel and platinum

What is being measured

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

  1. Objective response rate

    Proportion of patients achieved complete response or partial response

    Measured: From enrollment to end of study, up to 2 years

Secondary outcomes (2)

  1. Progression free survival

    The time duration of patients from enrollment to date of disease progression or death of any cause, regardless of whichever would occur first.

    Measured: From enrollment to date of disease progression or death of any cause, regardless of whichever would occur first, up to 2 years

  2. Overall survival

    The time duration of patients from enrollment to date of death of any cause.

    Measured: From enrollment to date of death of any cause, up to 2 years

Timeline

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

  1. First posted7 Jun 2022
  2. Study start9 Jun 2022
  3. Primary completion15 Apr 2026 (estimated)
  4. Study completion30 Aug 2026 (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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05407155
Sponsor's protocol ID
BETTER-NSCLC-2021
Acronym
BETTER
Status last verified
Apr 2026
First submitted
30 May 2022
Last updated
23 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lin Y, Yu Y, Hu Z, Wei C, Wang Z, Zhang Y, Wu Z, Yu B, Zhao X, Yu H, Wu X, Wang H, Wang J. Bevacizumab plus nab-paclitaxel and platinum as second-line therapy for driver-gene-negative non-squamous non-small cell lung cancer after immunochemotherapy: A prospective single-arm single-centre study. Clin Transl Med. 2026 Sep;16(9):e70814. doi: 10.1002/ctm2.70814.

    PubMed 42723577

Questions about this trial

What is this clinical trial studying?

A study testing bevacizumab plus nab-paclitaxel and platinum in people with Non-small Cell Lung Cancer Metastatic, 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 13 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: under way, not looking for participants, as of the sponsor's last update on 23 Apr 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.

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?

Objective response rate (time frame: From enrollment to end of study, up to 2 years). 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 NCT05407155, 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 23 Apr 2026.

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