Locally Advanced or Metastatic Non-Small Cell Lung CancerPhase 3NCT05673590
Utidelone Versus Docetaxel in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
A Phase 3 study testing Utidelone Injection and Docetaxel Injection in people with Locally Advanced or Metastatic Non-Small Cell Lung Cancer, run by Beijing Biostar Pharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
The purpose of this clinical trial is to compare Utidelone with Docetaxel in patients with locally advanced or metastatic non-small cell lung cancer previously failed platinum-containing chemotherapy regimens. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Locally Advanced or Metastatic Non-Small Cell Lung Cancer
- What is being tested?
- Utidelone Injection and Docetaxel 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
- 612 participants
- Where
- 1 siteChina
- Study dates
- 12 May 2023to 31 Dec 2025
- Phase
- Phase 3
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must sign the informed consent form and commit to complying with the requirements of this study.
- Male or female, ≥ 18 years of age, ≤ 70 years of age.
- Histologically or cytologically confirmed NSCLC, diagnosed as stage IV or stage IIIB-IIIC not amenable to radical surgery according to the IASLC (International Association for the Study of Lung Cancer) 8th edition staging system.
- The subject has at least one evaluable lesion (measurable or non-measurable) by the RECIST 1.1.
- The subject must have received a prior systemic chemotherapy (including neoadjuvant/adjuvant therapy) with a platinum-containing regimen, and are allowed to have ≤ 2 prior lines of chemotherapy for advanced cancer (excluding neoadjuvant/adjuvant chemotherapy).
- Patients without driver genes can be treated with/ not be treated with PD-1/PD-L1 inhibitors previously.
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- EGFR-positive patients are required to have received at least one or more EGFR-TKI (including Erlotinib, Gefitinib, Icotinib, Afatinib, Osimertinib, or other TKI for EGFR mutations, etc.), with disease progression or intolerance during or after treatment.
- Patients having had disease progression or intolerance to Osimertinib or other third-generation EGFR-TKI are eligible for enrollment (regardless of prior treatment with first/second-generation EGFR-TKI)
- Patients having had disease progression or intolerance to first- or second-generation EGFR-TKI (e.g., Erlotinib, Gefitinib, Icotinib, Afatinib, etc.) without evidence of EGFR T790M mutation after this treatment are eligible for enrollment.
- ALK fusion-positive patients who have received at least one or more ALK-TKI therapies and experienced disease progression or intolerance during or after treatment.
- -Patients having had disease progression or intolerance to the third-generation ALK-TKI Lorlatinib are eligible for enrollment (regardless of prior treatment with first- or second-generation ALK-TKI).
- Baseline routine blood tests within 1 week prior to enrollment is normal, with CTCAE grade ≤1 (based on normal values at each site's laboratory). No rhG-CSF use and no blood transfusion/EPO etc. within 14 days prior to enrollment.
- White blood cell count (WBC) ≥4.0 × 109/L.
- Neutrophil count (ANC) ≥ 1.5 × 109/L.
- platelet count (PLT) ≥ 100 × 109/L
- Hemoglobin ≥9.0 g/dL.
- Blood biochemistry test result is normal within 1 week prior to enrollment, with CTCAE grade ≤1 (based on normal values at each site's laboratory).
- Total bilirubin (TBIL) ≤ 1.5× the upper limit of normal value (ULN)
- Serum Glutamic Pyruvic Transaminase/Alanine Amino transferease (SGPT /ALT) ≤ 3× ULN (in the case of liver metastases ≤ 5 × ULN)
- Serum Glutamic-oxaloacetic Transaminase/Aspartate Aminotransferase (SGOT /AST) ≤ 3× ULN (in the case of liver metastases ≤ 5 × ULN)
- Creatinine clearance (Ccr) ≥60 ml/min.
- ECOG performance status 0-1.
- Fertile males and females of childbearing potential must agree to use effective contraception during the study and within 90 days after the last dose. The blood or urine pregnancy test for female patients of childbearing age prior to enrollment must be negative.
- Patients with a life expectancy of more than 3 months.
Who cannot join
- Patients who had other malignancies within the past 5 years, excluding cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and papillary thyroid cancer.
- Patients who have received antitumor therapy, including chemotherapy, radiotherapy, biologic therapy, targeted therapy, immunotherapy, or antitumor herbal therapy, within 4 weeks or 5 half-lives (≥ 2 weeks), whichever is shorter, prior to the first dose of the study drug.
- Patients who have had surgery of their major organs (excluding puncture biopsy) or had major injuries within 4 weeks prior to the first dose of study drug, or require elective surgery during the study.
- Patients with symptomatic peripheral neuropathy with CTCAE 5.0 grade ≥2
- Patients with known allergic reactions to any ingredient of the study drug.
- Patients who have previously been treated with docetaxel.
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- Patients who are pregnant (positive result from the pregnancy test) or lactating.
- Patients whose prior adverse reactions to anti-tumor therapy have not recovered to CTCAE 5.0 grade ≤1 (except for toxicity such as alopecia which poses no safety risk in the judgment of the investigator).
- Patients with symptomatic CNS metastases or meningeal metastases, or uncontrollable metastases, i.e., metastatic lesion progression confirmed by examination within 2 months after radiotherapy or other localized treatment, or those who are unsuitable for enrollment in the judgment of the investigator.
- Patients with uncontrollable bone metastases, i.e., patients who have had fracture or have the risk of fracture in recent days, patients who need surgery or localized radiotherapy in recent days, and patients under critical conditions in the judgment of the investigator.
- Patients with uncontrollable pleural effusion, pericardial effusion, or ascites requiring repeated drainage (once a month or more frequently)
- Patients with an active infection that currently requires systemic anti-infective therapy
- Patients having a history of immunodeficiency, including a positive HIV antibody test.
- Patients with active hepatitis B/C infection; patients with known active infection of syphilis.
- Patients with history of severe cardiovascular disease, including but not limited to:
- Serious cardiac rhythm or conduction abnormalities such as ventricular arrhythmias requiring clinical intervention, second- to third- degree atrioventricular block; mean QTcF >470ms from 3 12-lead ECGs at rest.
- Patients who had acute coronary syndrome, congestive heart failure, aortic dissection, stroke or other cardiovascular events at Class 3 or higher within 6 months prior to the first dose.
- Patients with clinically uncontrollable hypertension.
- Patients with other high-risk cardiac conditions in the judgment of the investigator.
- Patients with uncontrolled diabetes mellitus.
- Patients with mental disorders or poor compliance.
- Patients who concurrently participate in another clinical trial or use another investigational treatment.
- Subjects who, in the opinion of the investigator, have a history of other serious systemic diseases, or other reasons that make participation in this trial inadvisable.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Pulmonary Hospital
Shanghai
Caicun Zhou
About this study
Official title: A Phase III, Open-label, Randomized, Controlled Clinical Study of Utidelone Versus Docetaxel in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Previously Failed Platinum-containing Chemotherapy Regimens
The purpose of this clinical trial is to compare Utidelone with Docetaxel in patients with locally advanced or metastatic non-small cell lung cancer previously failed platinum-containing chemotherapy regimens. This phase III, open-label, randomized controlled trial aims to evaluate and compare the efficacy and safety of Utidelone and Docetaxel in the aforementioned lung cancers.
Read the detailed description
In this study, 612 patients will be screened, enrolled and randomly assigned in a 1:1 ratio to either the Utidelone (40 mg/m2/d intravenously once daily on days 1-5) treatment or the docetaxel (75 mg/m2/d, intravenously once on day 1) control group, stratified by prior immunotherapy status (PD-1/PD-L1 vs. no PD-1/PD-L1). Both groups will be treated in a 21-day cycle until disease progression or an occurrence of intolerable toxicities. Tumor assessments will be performed at baseline and every 6 weeks (±7 days) after randomization and continued until disease progression as assessed by RECIST v1.1 criteria, with or without discontinuation of study treatment; the EORTC QLQ-C30 questionnaire will be used to assess patients' quality of life based on a signed informed consent.
- Being tested
- Utidelone Injection, Docetaxel Injection
- Keywords
- Previously Failed, Platinum-Containing Chemotherapy Regimens
- 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.
Utidelone InjectionDrug
Pretreatment: diphenhydramine 40 mg by intramuscular injection or oral administration, and dexamethasone10 mg and cimetidine 300 mg by intravenous injection 30 minutes prior to Utidelone iv drip at the first day of each cycle. The dose of dexamethasone and diphenhydramine can be halved by the physician based on patient's condition in the following day through the fifth day in each cycle, as detailed in the protocol.
Dexamethasone 8 mg per oral, bid, one day prior to docetaxel iv drip for 3 days.
The treatment group will be treated with Utidelone Injection at 40 mg/m2/d intravenously once daily on days 1-5 in a 21-day cycle until disease progression or an occurrence of intolerable toxicities.
Docetaxel InjectionDrug
Pretreatment: Dexamethasone should be administered orally for 3 days at 16 mg per day (8 mg twice daily), starting one day before the start of Docetaxel.
The control group will be treated with Docetaxel Injection at 75 mg/m2/d, administered intravenously once on day 1. Patients in this group will be treated in 21-day cycles until disease progression or intolerable toxicities occurs.
| Study group | Role | What they receive |
|---|---|---|
| The treatment group-Utidelone monotherapy | Experimental | Drug: Utidelone Injection Dose: 40 mg/m2/d intravenously Regimen: once daily on days 1-5 in a 21-day cycle Receives: Drug: Utidelone Injection |
| The control group-Docetaxel monotherapy | Active comparator | Drug: Docetaxel Injection Dose:75 mg/m2/d, administered intravenously Regimen: once on day 1 in a 21-day cycle Receives: Drug: Docetaxel Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Comparing the OS of Utidelone and Docetaxel for locally advanced or metastatic non-small cell lung cancer patients who previously failed Platinum-containing chemotherapy regimens
Measured: 36 months
Secondary outcomes (3)
Progression Free Survival
Imaging-provable disease progression
Measured: 36 months
Objective Response Rate
The number of patients with an observed best efficacy rating of CR or PR as a percentage of the total number of evaluable patients according to RECIST 1.1.
Measured: 36 months
Clinical Benefit Rate
The number of patients with best efficacy ratings of CR, PR and SD as a percentage of the total number of evaluable patients according to RECIST 1.1.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2023
- Study start12 May 2023
- Primary completion15 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced or Metastatic Non-Small Cell Lung CancerStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 612 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Biostar Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Caicun Zhou, MD, Principal investigator, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05673590
- Sponsor's protocol ID
- BG01-2101
- Status last verified
- Dec 2022
- First submitted
- 30 Dec 2022
- Last updated
- 8 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Open-label, Randomized, Controlled Clinical Study of Utidelone Versus Docetaxel in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Previously Failed Platinum-containing Chemotherapy Regimens
- ClinicalTrials.gov ID
- NCT05673590
- Acronym / sponsor ID
- BG01-2101
- Keywords
- Previously Failed, Platinum-Containing Chemotherapy Regimens
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 612 participants (estimated)
- Lead sponsor
- Beijing Biostar Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 May 2023 (actual)
- Primary completion
- 15 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 6 Jan 2023 (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.
The purpose of this clinical trial is to compare Utidelone with Docetaxel in patients with locally advanced or metastatic non-small cell lung cancer previously failed platinum-containing chemotherapy regimens. This phase III, open-label, randomized controlled trial aims to evaluate and compare the efficacy and safety of Utidelone and Docetaxel in the aforementioned lung cancers.
Detailed description
In this study, 612 patients will be screened, enrolled and randomly assigned in a 1:1 ratio to either the Utidelone (40 mg/m2/d intravenously once daily on days 1-5) treatment or the docetaxel (75 mg/m2/d, intravenously once on day 1) control group, stratified by prior immunotherapy status (PD-1/PD-L1 vs. no PD-1/PD-L1). Both groups will be treated in a 21-day cycle until disease progression or an occurrence of intolerable toxicities. Tumor assessments will be performed at baseline and every 6 weeks (±7 days) after randomization and continued until disease progression as assessed by RECIST v1.1 criteria, with or without discontinuation of study treatment; the EORTC QLQ-C30 questionnaire will be used to assess patients' quality of life based on a signed informed consent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The treatment group-Utidelone monotherapy | Experimental | Drug: Utidelone InjectionDrug: Utidelone Injection Dose: 40 mg/m2/d intravenously Regimen: once daily on days 1-5 in a 21-day cycle |
| The control group-Docetaxel monotherapy | Active comparator | Drug: Docetaxel InjectionDrug: Docetaxel Injection Dose:75 mg/m2/d, administered intravenously Regimen: once on day 1 in a 21-day cycle |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Patients must sign the informed consent form and commit to complying with the requirements of this study.
- Male or female, ≥ 18 years of age, ≤ 70 years of age.
- Histologically or cytologically confirmed NSCLC, diagnosed as stage IV or stage IIIB-IIIC not amenable to radical surgery according to the IASLC (International Association for the Study of Lung Cancer) 8th edition staging system.
- The subject has at least one evaluable lesion (measurable or non-measurable) by the RECIST 1.1.
- The subject must have received a prior systemic chemotherapy (including neoadjuvant/adjuvant therapy) with a platinum-containing regimen, and are allowed to have ≤ 2 prior lines of chemotherapy for advanced cancer (excluding neoadjuvant/adjuvant chemotherapy).
Key exclusion criteria (23 listed)
- Patients who had other malignancies within the past 5 years, excluding cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and papillary thyroid cancer.
- Patients who have received antitumor therapy, including chemotherapy, radiotherapy, biologic therapy, targeted therapy, immunotherapy, or antitumor herbal therapy, within 4 weeks or 5 half-lives (≥ 2 weeks), whichever is shorter, prior to the first dose of the study drug.
- Patients who have had surgery of their major organs (excluding puncture biopsy) or had major injuries within 4 weeks prior to the first dose of study drug, or require elective surgery during the study.
- Patients with symptomatic peripheral neuropathy with CTCAE 5.0 grade ≥2
- Patients with known allergic reactions to any ingredient of the study drug.
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 InjectionPretreatment: diphenhydramine 40 mg by intramuscular injection or oral administration, and dexamethasone10 mg and cimetidine 300 mg by intravenous injection 30 minutes prior to Utidelone iv drip at the first day of each cycle. The dose of dexamethasone and diphenhydramine can be halved by the physician based on patient's condition in the following day through the fifth day in each cycle, as detailed in the protocol. Dexamethasone 8 mg per oral, bid, one day prior to docetaxel iv drip for 3 days. The treatment group will be treated with Utidelone Injection at 40 mg/m2/d intravenously once daily on days 1-5 in a 21-day cycle until disease progression or an occurrence of intolerable toxicities. | Drug | The treatment group-Utidelone monotherapy |
| Docetaxel InjectionPretreatment: Dexamethasone should be administered orally for 3 days at 16 mg per day (8 mg twice daily), starting one day before the start of Docetaxel. The control group will be treated with Docetaxel Injection at 75 mg/m2/d, administered intravenously once on day 1. Patients in this group will be treated in 21-day cycles until disease progression or intolerable toxicities occurs. | Drug | The control group-Docetaxel monotherapy |
Primary outcome
Overall Survival
Time frame: 36 months
Comparing the OS of Utidelone and Docetaxel for locally advanced or metastatic non-small cell lung cancer patients who previously failed Platinum-containing chemotherapy regimens
3 secondary outcomes
Progression Free Survival
Time frame: 36 months
Objective Response Rate
Time frame: 36 months
Clinical Benefit Rate
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
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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.
Caicun Zhou, MD principal investigator
Shanghai Pulmonary Hospital, Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Utidelone Injection and Docetaxel Injection in people with Locally Advanced or Metastatic Non-Small Cell Lung Cancer, run by Beijing Biostar Pharmaceuticals Co., Ltd. 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 24 inclusion and 23 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 8 Nov 2023. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 RONGGUO QIU, PhD (01186-56315388, rqiu2001@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: 36 months). 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 8 Nov 2023.