Non-small Cell Lung Cancer Patients with Brain MetastasesPhase 2NCT06683703
Utidelone Injection Combined with Bevacizumab Injection for Non-small Cell Lung Cancer Patients with Brain Metastases
A Phase 2 study testing Utidelone combined with Bevacizumab and Utidelone in people with Non-small Cell Lung Cancer Patients with Brain Metastases, run by Beijing Biostar Pharmaceuticals Co., Ltd..
Trial summary
This study is a prospective, multicenter, two-stage phase II clinical trial evaluating the efficacy and safety of Utidelone combined with Bevacizumab in patients with non-small cell lung cancer with brain metastases. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Non-small Cell Lung Cancer Patients with Brain Metastases
- What is being tested?
- Utidelone combined with Bevacizumab and Utidelone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to 1 Dec 2027
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent for the study was obtained from the participants and a written informed consent form (ICF) was provided.
- age ≥18 years old and ≤70 years old, regardless of gender;
- non-squamous non-small cell lung cancer (adenocarcinoma or adenocarcinoma component dominant) with brain parenchymal metastasis confirmed by histology or cytology, but unsuitable or refused local treatment/surgery;
- at least one measurable intracranial lesion according to RECIST v1.1 criteria (a lesion previously treated with radiotherapy could not be considered a target lesion unless it had definite progression after radiotherapy);
- stable brain metastases requiring no immediate or planned local treatment for brain metastases during the study;
- driver gene negative patients, unable to tolerate standard treatment or disease progression during or after first-line treatment with platinum-based chemotherapy and immunotherapy concurrent or sequential treatment, and with brain metastasis (regardless of whether the brain metastasis had been systematically treated); Note: (new) no progression within 6 months after the last dose of adjuvant therapy does not count as line count.
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- ECOG 0-1, life expectancy > 12 weeks;
- Patients should have adequate bone marrow reserve and no liver, kidney, or coagulation disorders. The following laboratory values should be met during screening and at baseline of enrollment:
- 1) Bone marrow reserve function: absolute neutrophil count ≥1.5×109/L and white blood cell count ≥3×109/L; Platelet count ≥100×109/L; Hemoglobin
- 90g/L; No blood transfusion or treatment with growth factors such as erythropoietin, thrombopoietin, or granulocyte colony-stimulating factor within 14 days; 2) Renal function: serum creatinine ≤1.5× upper limit of normal value (ULN) and creatinine clearance ≥50 mL/min (calculated according to Cockcroft and Gault formula); Urine protein <2+ (24-hour urine protein quantification within 7 days if baseline urine protein ≥2+, eligible if urine protein ≤1g) 3) Liver function: if there is no confirmed liver metastasis, AST and ALT should be ≤3×ULN; AST, ALT≤5×ULN if liver metastasis was confirmed; If there is no confirmed liver metastasis, the total bilirubin should be ≤1.5×ULN; Patients with confirmed liver metastasis or Gilbert's syndrome (indirect hyperbilirubinemia, total bilirubin ≤3×ULN); 4) Coagulation function: international normalized ratio (INR) ≤1.5, and activated partial prothrombin time (APTT) ≤1.5×ULN. (9) Eligible patients (men and women) of childbearing potential had to agree to use a reliable contraceptive method (hormonal or barrier methods or abstinence) with their partner during the trial and for at least 3 months after the last dose; Female patients of reproductive age had to have a negative blood or urine pregnancy test before enrollment.
Who cannot join
- primary malignant brain tumors and symptomatic or investigator-judged unstable brain metastases; Patients with leptomeningeal metastasis;
- mixed adenosquamous carcinoma with squamous cells as the main component confirmed by histology or cytology (squamous cell carcinoma cells accounted for ≥10%);
- The presence of EGFR, ALK, ROS1, NTRK and MET driver genes in patients with previous pathology can be determined according to the results of gene detection during the first-line treatment.
- Patients without disease progression after whole brain radiotherapy or stereotactic conformal radiotherapy for all intracranial lesions were not eligible for measurable lesions;
- third-space effusion (such as massive pericardial, pleural or peritoneal effusion) that could not be controlled by drainage or other methods within 4 weeks before enrollment;
- patients received palliative radiotherapy for non-target lesions for symptom relief (e.g., pain relief by radiotherapy for bone lesions) within 2 weeks before enrollment; Patients with previous whole brain radiotherapy (WBRT) were eligible if they had received previous stereotactic radiotherapy (SRT) or other local CNS treatments (such as intrathecal chemotherapy) more than 2 weeks after the first study dose.
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- Systemic therapy: all patients had received previous anti-angiogenic drugs (bevacizumab, recombinant human endostatin, anlotinib), including previous anti-angiogenic drugs; Patients received systemic anti-tumor therapy such as chemotherapy and immunotherapy within 4 weeks before the first study medication. Traditional Chinese medicine (including patent Chinese medicine) which had received small molecule targeted therapy or tumor indication within 2 weeks before the first study medication.
- known contraindications to gadolinium-based MRI, such as cardiac pacemaker, shraphings, or eye foreign bodies;
- two or more seizures within 4 weeks before enrollment;
- known to be allergic to eutideron injection, bevacizumab or any of its excipients;
- patients with grade ≥2 peripheral neuropathy or skin abnormalities requiring treatment, or any toxicity caused by previous antineoplastic therapy that has not recovered to CTCAE grade 5.0 ≤1 (excluding grade 2 alopecia) before the first dose of the study drug;
- There are contraindications to bevacizumab use, including but not limited to the following: - Uncontrolled severe hypertension (systolic blood pressure ≥ 150 mmHg and/or diastolic blood pressure ≥100 mmHg) - cerebral hemorrhage, These included brain metastases related to cancer - history of severe proteinuria (e.g., urine dipsticule ≥ 2+ or 24-hour urinary protein ≥ 2 g) - previous history of hypertensive crisis or hypertensive encephalopathy - history of central nervous system disease unrelated to cancer (e.g., convulsions) - vascular disease (e.g., aneurysm requiring treatment) within 6 months before the first dose of treatment. - history of hemoptysis (2 tablespoons of bright red blood per dose) within 3 months before the first dose - history of bleeding disorder or coagulation disorder in the absence of therapeutic anticoagulants - tumor involving large vessels - history of gastrointestinal perforation or fistula within 6 months before the first dose;
- Patients with malignant tumors other than the primary tumor within 5 years before screening (cured cervical carcinoma in situ, skin basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, breast ductal carcinoma in situ, and thyroid papillary carcinoma were excluded).
- had undergone major surgery within 4 weeks before the first dose of study medication or had not fully recovered from any previous invasive procedure;
- use of aspirin (>325mg/ day), clopidogrel, ticlopidine, cilostazol, or other drugs known to inhibit platelet function and/or a full-dose anticoagulant within 10 days before the first dose of study medication;
- patients with active hepatitis B and/or hepatitis C, that is, HBsAg positive and/or HBcAb positive simultaneously detected HBV DNA positive and/or anti-HCV positive and HCV RNA positive; Human immunodeficiency virus (HIV) antibody was positive; Treponema pallidum specific antibody was positive.
- Major cardiovascular and cerebrovascular diseases occurred within 6 months before the first study medication, such as congestive heart failure (New York Heart Association functional class ≥2), acute myocardial infarction, unstable angina, QTcF > 450 ms in men or QTcF > 470 ms in women (formula: See Appendix VII), stroke, transient ischemic attack, unstable deep-vein thrombosis, arterial thrombosis, and pulmonary embolism requiring medical intervention (except infusion-related thrombosis);
- Active infection requiring systemic therapy within 2 weeks before enrollment, such as severe pneumonia, bacteremia, sepsis, etc.; .
- Systemic glucocorticoid therapy (more than 4 mg of dexamethasone or equivalent per day for > 3 consecutive days) within 14 days before the first study dose or planned during the study period; Patients with chronic diseases such as severe radiation pneumonitis or severe interstitial pneumonitis were treated with immunosuppressive therapy.
- pregnant or lactating women;
- patients who participated in other anti-tumor clinical trials and received corresponding treatment within 4 weeks before the first study medication.
- Other reasons for not participating in the study as judged by the investigator.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Phase II Clinical Trial on the Efficacy and Safety of Utidelone Combined with Bevacizumab in Patients with Non-small Cell Lung Cancer with Brain Metastases.
This study is a prospective, multicenter, two-stage phase II clinical trial evaluating the efficacy and safety of Utidelone combined with Bevacizumab in patients with non-small cell lung cancer with brain metastases.
The main objective of the first stage was to determine the combined dose of the first stage and the second stage, and to compare the intracranial efficacy of the two treatment groups. Secondary objectives were to compare other intracranial efficacy, systemic efficacy, safety and tolerability between the two treatment groups.In the second stage, the main purpose was to evaluate the intracranial efficacy of Utidelone combined with Bevacizumab in patients, and the secondary purpose was to evaluate the other intracranial efficacy, systemic efficacy, safety and tolerability of Utidelone combined with Bevacizumab in patients, and to explore the improvement of patients' quality of life.
Read the detailed description
Patients with non-small cell lung cancer and brain metastases were enrolled in this study. The first stage consisted of a safety run-in (combination group only) and an expansion. During the safety run-in phase, a 3+3 dose step-down design was used, starting with 30mg/m2/d of Utidelone,D1-D5,Q3W plus Bevacizumab 15mg/kg/Q3w. The dose of Utidelone was reduced by up to one dose (to 25mg per square meter), and the dose of Bevacizumab was unchanged (15mg/kg/Q3w). We planned to enroll 3 to 12 patients in the safety run-in. In the extension, the patients were randomly assigned to the combination group and the monotherapy group (hereinafter referred to as the monotherapy group). 30 patients were planned to be enrolled in the monotherapy group, and 24 or 27 patients were enrolled in the combination group according to the safety run-in. The second stage of dosing was the same as the first stage of expansion in the combination-therapy group, and the results of the first stage determined whether to proceed to the second stage. If second stage was reached, an additional 52 patients would be enrolled.
- Being tested
- Utidelone combined with Bevacizumab, Utidelone
- Keywords
- efficacy and safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Utidelone combined with BevacizumabDrug
The initial dose was Utidelone 30mg/m2/d,D1-D5,Q3W+ Bevacizumab 15mg/kg/Q3w. If dose adjustment was required due to DLT events, Utidelone was reduced by up to one dose (to 25mg/m2/d), while the dose of Bevacizumab remained unchanged (15mg/kg).
UtideloneDrug
Utidelone injection, 30mg/m2/d, D1-D5 for 5 consecutive days, every 21 days as a treatment cycle
Utidelone combined with BevacizumabDrug
In the combination group, the dose of Utidelone was determined according to the safety run-in period, 30 mg/m2/d or 25mg/m2/d, D1-D5,Q3W; The dose of Bevacizumab was 15 mg/kg/3W.
Utidelone combined with BevacizumabDrug
The dose of Utidelone was 30 mg/m2/d or 25mg/m2/d, D1-D5,Q3W; The dose of Bevacizumab was 15 mg/kg/3w.
| Study group | Role | What they receive |
|---|---|---|
| Stage 1 Safety run-in | Experimental | Utidelone + Bevacizumab Receives: Drug: Utidelone combined with Bevacizumab |
| Stage 1 Extension: Monotherapy group | Experimental | Utidelone Receives: Drug: Utidelone |
| Stage 1 Extension: Combined treatment group | Experimental | Utidelone+ Bevacizumab Receives: Drug: Utidelone combined with Bevacizumab |
| Stage 2 | Experimental | Utidelone + Bevacizumab Receives: Drug: Utidelone combined with Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intracranial objective response rate (iORR) according to the RECIST 1.1.
iORR is defined as the proportion of subjects with a confirmed intracranial response of complete response (CR) and partial response (PR).
Measured: Time Frame: 18 months
Determining the Expansion Dose
The first safety run-in phase was used to determine the dose to be administered in the combination group in the extension phase.
Measured: 18 months
Secondary outcomes (7)
Intracranial progression-free survival (iPFS)
iPFS: defined as time from dose index to intracranial disease progression or death from any cause.
Measured: Time Frame: 18 months
Intracranial disease control rate (iDCR) according to the RECIST 1.1.
iDCR: defined as the proportion of subjects with confirmed intracranial response with CR, PR, and SD.
Measured: Time Frame: 18 months
Objective Response Rate （ORR）according to the RECIST 1.1.
ORR: defined as the proportion of subjects with a confirmed CR and PR.
Measured: Time Frame: 18 months
Disease Control Rate （DCR）according to the RECIST 1.1.
DCR: defined as the proportion of subjects with confirmed CR and PR and SD.
Measured: Time Frame: 18 months
Progression-Free Survival, PFS
PFS : defined as time from first dose to tumor-assessed disease progression (intracranial or extracranial) or death from any cause.
Measured: Time Frame: 18 months
Overall survival (OS) in all participants
OS : defined as time from first dose to death from any cause.
Measured: Time Frame: Up to 2 years
Treatment-related Adverse Event-TRAE
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: Time Frame: Until 28 days after the last dose of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start1 Dec 2024 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung Cancer Patients with Brain MetastasesStudies of the same condition, open and under way.
- 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Biostar Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06683703
- Sponsor's protocol ID
- BG01-2401
- Status last verified
- Nov 2024
- First submitted
- 6 Nov 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Trial on the Efficacy and Safety of Utidelone Combined with Bevacizumab in Patients with Non-small Cell Lung Cancer with Brain Metastases.
- ClinicalTrials.gov ID
- NCT06683703
- Acronym / sponsor ID
- BG01-2401
- Keywords
- efficacy and safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- Beijing Biostar Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 12 Nov 2024 (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 study is a prospective, multicenter, two-stage phase II clinical trial evaluating the efficacy and safety of Utidelone combined with Bevacizumab in patients with non-small cell lung cancer with brain metastases.
The main objective of the first stage was to determine the combined dose of the first stage and the second stage, and to compare the intracranial efficacy of the two treatment groups. Secondary objectives were to compare other intracranial efficacy, systemic efficacy, safety and tolerability between the two treatment groups.In the second stage, the main purpose was to evaluate the intracranial efficacy of Utidelone combined with Bevacizumab in patients, and the secondary purpose was to evaluate the other intracranial efficacy, systemic efficacy, safety and tolerability of Utidelone combined with Bevacizumab in patients, and to explore the improvement of patients' quality of life.
Detailed description
Patients with non-small cell lung cancer and brain metastases were enrolled in this study. The first stage consisted of a safety run-in (combination group only) and an expansion. During the safety run-in phase, a 3+3 dose step-down design was used, starting with 30mg/m2/d of Utidelone,D1-D5,Q3W plus Bevacizumab 15mg/kg/Q3w. The dose of Utidelone was reduced by up to one dose (to 25mg per square meter), and the dose of Bevacizumab was unchanged (15mg/kg/Q3w). We planned to enroll 3 to 12 patients in the safety run-in. In the extension, the patients were randomly assigned to the combination group and the monotherapy group (hereinafter referred to as the monotherapy group). 30 patients were planned to be enrolled in the monotherapy group, and 24 or 27 patients were enrolled in the combination group according to the safety run-in. The second stage of dosing was the same as the first stage of expansion in the combination-therapy group, and the results of the first stage determined whether to proceed to the second stage. If second stage was reached, an additional 52 patients would be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Stage 1 Safety run-in | Experimental | Drug: Utidelone combined with BevacizumabUtidelone + Bevacizumab |
| Stage 1 Extension: Monotherapy group | Experimental | Drug: UtideloneUtidelone |
| Stage 1 Extension: Combined treatment group | Experimental | Drug: Utidelone combined with BevacizumabUtidelone+ Bevacizumab |
| Stage 2 | Experimental | Drug: Utidelone combined with BevacizumabUtidelone + Bevacizumab |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Informed consent for the study was obtained from the participants and a written informed consent form (ICF) was provided.
- age ≥18 years old and ≤70 years old, regardless of gender;
- non-squamous non-small cell lung cancer (adenocarcinoma or adenocarcinoma component dominant) with brain parenchymal metastasis confirmed by histology or cytology, but unsuitable or refused local treatment/surgery;
- at least one measurable intracranial lesion according to RECIST v1.1 criteria (a lesion previously treated with radiotherapy could not be considered a target lesion unless it had definite progression after radiotherapy);
- stable brain metastases requiring no immediate or planned local treatment for brain metastases during the study;
Key exclusion criteria (22 listed)
- primary malignant brain tumors and symptomatic or investigator-judged unstable brain metastases; Patients with leptomeningeal metastasis;
- mixed adenosquamous carcinoma with squamous cells as the main component confirmed by histology or cytology (squamous cell carcinoma cells accounted for ≥10%);
- The presence of EGFR, ALK, ROS1, NTRK and MET driver genes in patients with previous pathology can be determined according to the results of gene detection during the first-line treatment.
- Patients without disease progression after whole brain radiotherapy or stereotactic conformal radiotherapy for all intracranial lesions were not eligible for measurable lesions;
- third-space effusion (such as massive pericardial, pleural or peritoneal effusion) that could not be controlled by drainage or other methods within 4 weeks before enrollment;
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 |
|---|---|---|
| Utidelone combined with BevacizumabThe initial dose was Utidelone 30mg/m2/d,D1-D5,Q3W+ Bevacizumab 15mg/kg/Q3w. If dose adjustment was required due to DLT events, Utidelone was reduced by up to one dose (to 25mg/m2/d), while the dose of Bevacizumab remained unchanged (15mg/kg). | Drug | Stage 1 Safety run-in |
| UtideloneUtidelone injection, 30mg/m2/d, D1-D5 for 5 consecutive days, every 21 days as a treatment cycle | Drug | Stage 1 Extension: Monotherapy group |
| Utidelone combined with BevacizumabIn the combination group, the dose of Utidelone was determined according to the safety run-in period, 30 mg/m2/d or 25mg/m2/d, D1-D5,Q3W; The dose of Bevacizumab was 15 mg/kg/3W. | Drug | Stage 1 Extension: Combined treatment group |
| Utidelone combined with BevacizumabThe dose of Utidelone was 30 mg/m2/d or 25mg/m2/d, D1-D5,Q3W; The dose of Bevacizumab was 15 mg/kg/3w. | Drug | Stage 2 |
Primary outcome
Intracranial objective response rate (iORR) according to the RECIST 1.1.
Time frame: Time Frame: 18 months
iORR is defined as the proportion of subjects with a confirmed intracranial response of complete response (CR) and partial response (PR).
Determining the Expansion Dose
Time frame: 18 months
The first safety run-in phase was used to determine the dose to be administered in the combination group in the extension phase.
7 secondary outcomes
Intracranial progression-free survival (iPFS)
Time frame: Time Frame: 18 months
Intracranial disease control rate (iDCR) according to the RECIST 1.1.
Time frame: Time Frame: 18 months
Objective Response Rate （ORR）according to the RECIST 1.1.
Time frame: Time Frame: 18 months
Disease Control Rate （DCR）according to the RECIST 1.1.
Time frame: Time Frame: 18 months
Progression-Free Survival, PFS
Time frame: Time Frame: 18 months
Overall survival (OS) in all participants
Time frame: Time Frame: Up to 2 years
Treatment-related Adverse Event-TRAE
Time frame: Time Frame: Until 28 days after the last dose of treatment
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 12 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Utidelone combined with Bevacizumab and Utidelone in people with Non-small Cell Lung Cancer Patients with Brain Metastases, run by Beijing Biostar Pharmaceuticals Co., Ltd..
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 10 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: opening soon, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Rongguo Qiu (010-56315388, Rqiu2001@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intracranial objective response rate (iORR) according to the RECIST 1.1. (time frame: Time Frame: 18 months). The study lists 2 primary outcomes in all. 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 12 Nov 2024.