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Non-Small Cell Lung CancerPhase 2EAGLENCT05491811

Ensartinib in Combination With Bevacizumab in ALK-positive NSCLC Patients With TP53 Mutation

A Phase 2 study testing Ensartinib and Bevacizumab in people with Non-Small Cell Lung Cancer, run by Sun Yat-sen 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

This is a prospective, single-arm, multicenter, phase II study to investigate the efficacy and safety of Ensartinib plus Bevacizumab in metastatic anaplastic lymphoma kinase (ALK)-rearranged Non-Small Cell Lung Cancer (NSCLC) with TP53 mutation. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
Ensartinib and Bevacizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
1 siteChina
Study dates
1 Aug 2022to Dec 2026
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

  • Histologically or cytologically confirmed advanced (stage IIIB) or metastatic (stage IV) NSCLC;
  • ALK positive with TP53 mutation was confirmed by tissue samples or blood in each center; TP53 mutation detection needs to be confirmed by NGS. ALK positive can be detected by NGS,IHC,RT-PCR and FISH;
  • Age ≥ 18 years old;
  • ALK-TKI-naive patients, and allowed to have received at most one line previous chemotherapy;
  • ECOG Performance status (PS) score is 0-2;
  • Karnofsky Performance Status of ≥70;
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  • Subjects with CNS metastases are only eligible if the CNS metastases are adequately treated with radiotherapy and/or surgery and subjects are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 1 week prior to randomization.
  • A.Patients receiving radiotherapy or radiosurgery with a dose exceeding 30 Gy will have 3 weeks for neurological stabilization before randomization.
  • B.This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.
  • Life expectancy of at least 12 weeks;
  • Able to swallow oral drugs;
  • It has certain organ system functions, defined as follows:
  • Absolute neutrophil count (ANC) ≥1.5 x 109/L B. Platelets ≥100 x 109/L C. hemoglobin ≥9 g per deciliter (≥90g per liter) note that blood transfusions are permitted to achieve the required hemoglobin level.
  • Total bilirubin ≤1.5 times upper limit of normal (ULN) E. In the absence of liver metastases, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN; In case of liver metastasis, ≤5×ULN.
  • Creatinine ≤1.5 x ULN. If ≥ 1.5 × ULN and creatinine clearance value calculated by Cockcroft-Gault method ≥ 50 mL/min (0.83 mL/s), patients were still eligible for inclusion.
  • Female subjects of reproductive age must undergo a negative serum pregnancy test within 3 days before the start of the study medication and be willing to use a medically approved highly effective contraceptive measure (e.g., intrauterine device, contraceptive pill, or condom) during the study and within 3 months after the last administration of the study medication; Male subjects with a female partner of reproductive age should be surgically sterilized or agree to use an effective method of contraception during the study period and for 3 months after the last study dose.
  • Willing and able to follow the test and follow-up procedures.
  • Be able to understand the nature of the trial and complete the signing of written informed consent.

Who cannot join

  • Only ALK positive or TP53 mutation;
  • Patients who have received any previous ALK-TKI treatment;
  • Subjects with known EGFR mutations which are sensitive to available targeted inhibitor therapy (including, but not limited to, deletions in exon 19 and exon 21 [L858R] substitution mutations) are excluded. All subjects with non-squamous histology must have been tested locally for EGFR mutation status; use of an FDA-approved test is strongly encouraged (EGFR mutation testing may be performed during the Screening Period, Non-squamous subjects with unknown or indeterminate EGFR status may not be included);
  • Subjects with untreated CNS metastases are excluded;
  • Subjects with previous malignancies (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colon, cervical/dysplasia, melanoma, or breast) are excluded unless a complete remission was achieved at least 2 years prior to study entry and no additional therapy is required or anticipated to be required during the study period;
  • Active hepatitis B (serum HBV DNA≥1.0E+4 copies /ml[i.e. 2,000 IU/ml]), positive for hepatitis C virus antibody, HIV antibody, and treponema pallidum antibody;
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  • Women of childbearing age who had a positive serum pregnancy test 7 days before the start of treatment, women who were pregnant or lactating, or male and female subjects who did not take effective contraceptive measures or planned to have children during the whole treatment period and 3 months after the end of treatment;
  • Patients who have used any of the following drugs within 14 days before the first dose or need to combine them during treatment: drugs at risk for prolonged QTc and/or torsive-tip ventricular tachycardia; CYP3A strong inhibitor or strong inducer;
  • Major surgery or immunotherapy was performed within 4 weeks before the first dose; He received radiotherapy within 2 weeks before the first dose.
  • Imaging (CT or MRI) showed that the tumor invaded the great blood vessels or it was judged that the tumor was very likely to invade the important blood vessels and cause fatal massive bleeding during the subsequent study
  • Previous interstitial lung disease, drug-induced interstitial disease, or any clinically documented active interstitial lung disease; CT scan at baseline revealed the presence of idiopathic pulmonary fibrosis
  • Other severe, acute, or chronic medical conditions, including uncontrolled diabetes or medical or psychiatric disorders or laboratory abnormalities, that, in the opinion of the investigator, may increase the risk associated with study participation or may interfere with the interpretation of the study results;
  • Other circumstances deemed inappropriate by the investigator for participation in the trial.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sun Yat-Sen University Cancer Center

    Guangzhou, Guangdong

Other trials in China

About this study

Official title: Evaluate the Efficacy and Safety of Ensartinib and Bevacizumab in Patients With Advanced, ALK-Rearranged Combined With TP53 Mutation, Non-Small Cell Lung Cancer: A Prospective, Open-label, Multi-center, Single-arm, Phase II Trial

This is a prospective, single-arm, multicenter, phase II study to investigate the efficacy and safety of Ensartinib plus Bevacizumab in metastatic anaplastic lymphoma kinase (ALK)-rearranged Non-Small Cell Lung Cancer (NSCLC) with TP53 mutation.

Read the detailed description

Patients with advanced or metastatic NSCLC with ALK positive and TP53 mutation were clinically confirmed. Medical history collection, physical examination, laboratory examination, concomitant diseases and medication records were taken according to the patient's diagnosis and treatment. Laboratory examination included but not limited to blood routine and blood biochemical examination. To determine whether patients were suitable for treatment with Ensartinib combined with Bevacizumab according to the entry and exclusion criteria. For patients who met the prescription, blood samples were collected within 1 week before medication. Imaging examination was performed every 6 weeks (±7 days) in the first 2 years and every 12 weeks (±7 days) in the second 2 years. Examination items included chest CT, head MRI; See if additional tests (e.g., bone scan, total abdominal augmentation) are needed based on the actual clinical situation. When the disease progresses, blood samples should be collected within 4 weeks after the disease progression, and if possible, tumor tissues of the progressive lesions after the disease progression should be collected. Patients can choose to continue to use the regimen recommended by the doctor if the doctor considers that the use of Ensartinib therapy or combination therapy may still bring benefit to the patient. The follow-up treatment plan, the best efficacy evaluation, and the duration of treatment were recorded. When the end point of follow-up was reached, that is, the patient died or was lost to follow-up, the date of death or loss and the main causes should be tracked and recorded in detail.

Being tested
Ensartinib, Bevacizumab
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.

  • EnsartinibDrug

    Participants will receive Ensartinib 225 mg oral once daily from baseline until disease progression, unacceptable toxicity, withdrawal of consent or death.

  • BevacizumabDrug

    Also called MIL60

    Participants will receive 7.5 mg/kg intravenous on Day 1 of 21 day cycles (every 3 weeks) from baseline until disease progression, unacceptable toxicity, withdrawal of consent or death.

Study groups in NCT05491811
Study groupRoleWhat they receive
Ensartinib and BevacizumabExperimentalEnsartinib 225 mg oral once daily with Bevacizumab 7.5mg/kg intravenous every 3 weeks
Receives: Drug: Ensartinib; Drug: Bevacizumab

What is being measured

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

  1. 12-month Progression-free Survival (PFS) rate

    Progression-free survival (PFS) using Investigator assessment as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). Progression-free survival (PFS) is defined as the time from beginning of study treatment until the date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdraws from randomized therapy or receives another anti-cancer therapy prior to progression. Patients who have not progressed or died at the time of analysis will be censored at the time of the latest date of assessment from their last evaluable Response Evaluation Criteria in Solid Tumors (RECIST) assessment.

    Measured: The primary analysis of 12-month PFS rate based on investigator assessment will occur when PFS maturity is observed at approximately 12 months after the first patient begin study treatment

Secondary outcomes (6)

  1. PFS

    PFS using Investigator assessment as defined by RECIST 1.1. PFS is defined as the time from beginning of study treatment until the date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdraws from randomized therapy or receives another anti-cancer therapy prior to progression. Patients who have not progressed or died at the time of analysis will be censored at the time of the latest date of assessment from their last evaluable RECIST assessment.

    Measured: Through study completion, an average of 18 months

  2. Objective Response Rate (ORR)

    ORR was defined as the percentage of participants who attained Complete Response (CR) or Partial Response (PR). As per RECIST v1.1, CR: Disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm, PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.

    Measured: 8 weeks

  3. Duration of Response (DoR)

    DOR was defined as the time from when response (CR or PR) was first documented to first documented disease progression or death

    Measured: 12 months

  4. Disease Control Rate (DCR)

    DCR was defined as the proportion of CR+PR+SD subjects to total subjects

    Measured: through study completion, an average of 12 months

  5. Overall Survival (OS)

    OS was defined as the time from randomization to death from any cause.

    Measured: Through study completion, an average of 18 months

  6. Disease-related symptom improvement

    To measure disease-related symptoms we will apply the Lung Cancer Symptom Scale (LCSS). The LCSS is designed as a disease-specific measure of quality of life particularly for use in clinical trials. It evaluates six major symptoms associated with lung malignancies and their effect on overall symptomatic distress, functional activities, and global quality of life. The scale consists of two segments, one completed by the patient (9 items) and one completed by the health care professional (6 items). Scoring is assigned as follows: The patient scale consists of 9 visual analogue scales (100 mm horizontal line). Patient puts a mark on line to indicate intensity of response to the items in question (0 = lowest rating). The observer scale consists of a 5-point categorical scale (100=none; 75=mild; 50=moderate; 25=marked; 0=severe). The score is equal to the length of line marked by patient. An average of the aggregate score of all 9 items is the total score (0-100, 0= least symptom burden).

    Measured: 12 weeks since treatment start

Timeline

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

  1. First posted8 Aug 2022
  2. Study start1 Aug 2022
  3. Primary completion31 Aug 2024
  4. Study completionDec 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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05491811
Sponsor's protocol ID
BD-EN-IV010
Acronym
EAGLE
Status last verified
Apr 2026
First submitted
4 Aug 2022
Last updated
4 May 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 Ensartinib and Bevacizumab in people with Non-Small Cell Lung Cancer, run by Sun Yat-sen 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 18 inclusion and 13 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 4 May 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 Progression-free Survival (PFS) rate (time frame: The primary analysis of 12-month PFS rate based on investigator assessment will occur when PFS maturity is observed at approximately 12 months after the first patient begin study 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 NCT05491811.

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 4 May 2026.

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