Advanced Non-small Cell Lung CancerPhase 2NCT03693547
Clinical Study of Utidelone Injection in Patients With Advanced Non-small Cell Lung Cancer（NSCLC）
A Phase 2 study testing utidelone injection in people with Advanced Non-small Cell Lung Cancer, run by Beijing Biostar Pharmaceuticals Co., Ltd. at 4 sites in China.
Trial summary
To assess the effectiveness and safety of utidelone injection in patients with advanced or metastatic NSCLC as a phase II trial Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Advanced Non-small Cell Lung Cancer
- What is being tested?
- utidelone injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 4 sitesChina
- Study dates
- 22 Apr 2019to 10 Aug 2021
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed non-small cell lung cancer
- NSCLC patients who are not suitable for surgery or radical radiotherapy or chemotherapy, or who have failed to or are intolerable for standard treatment in local advanced or metastatic NSCLC;
- NSCLC patients failed or intolerable to previous standard second-line treatment (including platinum chemotherapy or targeted therapy);
- Patients who did not receive chemotherapy, radiotherapy, surgical therapy, molecularly targeted drug therapy, or immunotherapy 4 weeks prior to enrollment;
- Age 18 -70 years old, ECOG performance status of 0-1; Life expectancy of 3 months or more;
- Patients must have measurable disease, defined as at least one target lesion that can be accurately measured by imaging techniques in at least one dimension as ≥20 mm with conventional computed tomography (CT), ≥10 mm with spiral CT scan (≥15mm for lymph node) within 3 weeks before enrolment;
Show all 11Show fewer
- Patients with no brain metastases or with brain metastases but are stable for more than 4 weeks after treatment;
- Peripheral neuropathy (PN) <grade 2 on the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 within 4 weeks before enrolment;
- Patients must have normal haematology as defined below: HGB ≥9 g/L, absolute neutrophil count ≥1.5×109/L, platelets ≥80×109/L, bilirubin ≤1.5× the upper limit of normal (ULN) (patients with liver metastasis ≤3xULN), aspartate transaminase (AST)/ alanine transaminase (ALT) ≤2.5 ×ULN (patients with liver metastasis ≤5xULN), and creatinine clearance ≥45 mL/min;
- Patients with no major organ dysfunctions and heart disease;
- Patients who give written informed consent with good compliance.
Who cannot join
- Patients who are pregnant or breast feeding;
- Patients with active tuberculosis
- Patients with high possibility of interstitial lung disease ;
- Patients with comorbidities, such as carcinomatous meningitis, central nervous system (CNS) metastasis, other active malignancies requiring simultaneous treatment, but not including cervical cancer in situ or basal cell carcinoma of the skin, severe disorders of the heart, lung, liver, or kidneys, severe hypertension, uncontrolled diabetes, severe gastrointestinal ulceration, active infections in need of antibiotics, or with incontrollable psychiatric history;
- patients with HIV, untreated active hepatitis；
- Patients with poor compliance;
- Patients not fitted for this study determined by the investigators.
Trial locations and contacts
4 sites in 1 country.
China4 sites
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Peking Union Hospital
Beijing, Beijing Municipality
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
Tianjin People's Hospital
Tianjin, Tianjin Municipality
About this study
Official title: Open, Multicenter, Monotherapy, Phase II Clinical Study of Utidelone Injection in Patients With Advanced Non-small Cell Lung Cancer After Failure or Intolerability to Second-line Standard Treatment
To assess the effectiveness and safety of utidelone injection in patients with advanced or metastatic NSCLC as a phase II trial
- Conditions
- Advanced Non-small Cell Lung Cancer
- Being tested
- utidelone injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
utidelone injectionDrug
Also called UTD1 injection
utidelone monotherapy in patients with advanced NSCLC by utidelone
| Study group | Role | What they receive |
|---|---|---|
| utidelone | Experimental | Utidelone Injection: 30 mg/m2/day, IV on day 1-day 5 of each 21 day cycle, administered to enrolled patients with advanced NSCLC Receives: Drug: utidelone injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor response to utidelone treatment
Reflected by percentage of tumor size reduction or regression, assessed by imaging techniques and expressed as Objective Response Rate (ORR）ORR is defined as the proportion of patients with a best overall response of Complete Response (CR) or Partial Response (PR) according to RECIST. 1.1.
Measured: 6 months from first study treatment
Secondary outcomes (3)
Progression free survival (PFS)
PFS is defined as the duration of time from first study treatment to disease progression or death from any cause as documented by the investigator
Measured: 1 year from first study treatment
Overall survival (OS)
OS is defined as the duration of time from first study treatment until death from any cause.
Measured: 2 year from enrolment
Incidence of treatment-emergent adverse events based the Common Terminology Criteria for Adverse Events (CTCAE) version 4·03
Observe and record incidence of adverse events and severe adverse events associated with utidelone treatment, assessed by investigators according to CTCAE version 4·03
Measured: 1 year from first study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2018
- Study start22 Apr 2019
- Primary completion25 Jun 2021
- Study completion10 Aug 2021
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 Advanced 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Biostar Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chengdu Biostar Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- YUANKAI SHI, MD, PhD, Principal investigator, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03693547
- Sponsor's protocol ID
- BG01-1801
- Status last verified
- Jan 2023
- First submitted
- 29 Sep 2018
- Last updated
- 10 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Shi Y, Chen G, Zhao Y, Zhao J, Lin L. Efficacy and safety of utidelone for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer who have failed standard second-line treatment: A phase 2 clinical trial (BG01-1801). Cancer Pathog Ther. 2023 Oct 29;2(2):103-111. doi: 10.1016/j.cpt.2023.10.006. eCollection 2024 Apr.
PubMed 38601485
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open, Multicenter, Monotherapy, Phase II Clinical Study of Utidelone Injection in Patients With Advanced Non-small Cell Lung Cancer After Failure or Intolerability to Second-line Standard Treatment
- ClinicalTrials.gov ID
- NCT03693547
- Acronym / sponsor ID
- BG01-1801
- Conditions
- Advanced Non-small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Beijing Biostar Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Chengdu Biostar Pharmaceuticals
- Study start
- 22 Apr 2019 (actual)
- Primary completion
- 25 Jun 2021 (actual)
- Study completion
- 10 Aug 2021 (actual)
- First posted
- 3 Oct 2018 (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 assess the effectiveness and safety of utidelone injection in patients with advanced or metastatic NSCLC as a phase II trial
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| utidelone | Experimental | Drug: utidelone injectionUtidelone Injection: 30 mg/m2/day, IV on day 1-day 5 of each 21 day cycle, administered to enrolled patients with advanced NSCLC |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologically or cytologically confirmed non-small cell lung cancer
- NSCLC patients who are not suitable for surgery or radical radiotherapy or chemotherapy, or who have failed to or are intolerable for standard treatment in local advanced or metastatic NSCLC;
- NSCLC patients failed or intolerable to previous standard second-line treatment (including platinum chemotherapy or targeted therapy);
- Patients who did not receive chemotherapy, radiotherapy, surgical therapy, molecularly targeted drug therapy, or immunotherapy 4 weeks prior to enrollment;
- Age 18 -70 years old, ECOG performance status of 0-1; Life expectancy of 3 months or more;
Key exclusion criteria (7 listed)
- Patients who are pregnant or breast feeding;
- Patients with active tuberculosis
- Patients with high possibility of interstitial lung disease ;
- Patients with comorbidities, such as carcinomatous meningitis, central nervous system (CNS) metastasis, other active malignancies requiring simultaneous treatment, but not including cervical cancer in situ or basal cell carcinoma of the skin, severe disorders of the heart, lung, liver, or kidneys, severe hypertension, uncontrolled diabetes, severe gastrointestinal ulceration, active infections in need of antibiotics, or with incontrollable psychiatric history;
- patients with HIV, untreated active hepatitis；
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 injectionAlso: UTD1 injectionutidelone monotherapy in patients with advanced NSCLC by utidelone | Drug | utidelone |
Primary outcome
Tumor response to utidelone treatment
Time frame: 6 months from first study treatment
Reflected by percentage of tumor size reduction or regression, assessed by imaging techniques and expressed as Objective Response Rate (ORR）ORR is defined as the proportion of patients with a best overall response of Complete Response (CR) or Partial Response (PR) according to RECIST. 1.1.
3 secondary outcomes
Progression free survival (PFS)
Time frame: 1 year from first study treatment
Overall survival (OS)
Time frame: 2 year from enrolment
Incidence of treatment-emergent adverse events based the Common Terminology Criteria for Adverse Events (CTCAE) version 4·03
Time frame: 1 year from first study treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
- Derived from this study: PubMed 38601485Shi Y, Chen G, Zhao Y, Zhao J, Lin L. Efficacy and safety of utidelone for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer who have failed standard second-line treatment: A phase 2 clinical trial (BG01-1801). Cancer Pathog Ther. 2023 Oct 29;2(2):103-111. doi: 10.1016/j.cpt.2023.10.006. eCollection 2024 Apr.
Related trials for Advanced Non-small Cell Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
RecruitingPhase 3
Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301)
NSCLC (Non-small Cell Lung Cancer), Non-Small Cell Lung Cancer
RecruitingPhase 2
A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Non-Small Cell Lung Cancer
Non-Small Cell Lung Cancer
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.
YUANKAI SHI, MD, PhD principal investigator
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, China
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing utidelone injection in people with Advanced Non-small Cell Lung Cancer, run by Beijing Biostar Pharmaceuticals Co., Ltd. at 4 sites 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 11 inclusion and 7 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: finished, as of the sponsor's last update on 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Tumor response to utidelone treatment (time frame: 6 months from first 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 NCT03693547, 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 10 Jan 2023.