Clinical Study of Utidelone Injection in Patients With Advanced Non-small Cell Lung Cancer（NSCLC）

Advanced Non-small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03693547
• Other study ID #: BG01-1801
• Status: Completed
• Phase: Phase 2
• Start date: April 22, 2019
• Est. completion date: August 10, 2021

Study information

• Verified date: January 2023
• Source: Beijing Biostar Pharmaceuticals Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To assess the effectiveness and safety of utidelone injection in patients with advanced or metastatic NSCLC as a phase II trial

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: August 10, 2021
• Est. primary completion date: June 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Histologically or cytologically confirmed non-small cell lung cancer

2. 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;

3. NSCLC patients failed or intolerable to previous standard second-line treatment (including platinum chemotherapy or targeted therapy);

4. Patients who did not receive chemotherapy, radiotherapy, surgical therapy, molecularly targeted drug therapy, or immunotherapy 4 weeks prior to enrollment;

5. Age 18 -70 years old, ECOG performance status of 0-1; Life expectancy of 3 months or more;

6. 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;

7. Patients with no brain metastases or with brain metastases but are stable for more than 4 weeks after treatment;

8. Peripheral neuropathy (PN) <grade 2 on the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 within 4 weeks before enrolment;

9. 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;

10. Patients with no major organ dysfunctions and heart disease;

11. Patients who give written informed consent with good compliance.

Exclusion Criteria:

1. Patients who are pregnant or breast feeding;

2. Patients with active tuberculosis

3. Patients with high possibility of interstitial lung disease ;

4. 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;

5. patients with HIV, untreated active hepatitis;

6. Patients with poor compliance;

7. Patients not fitted for this study determined by the investigators.

Related Conditions & MeSH terms

• Advanced Non-small Cell Lung Cancer
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms

Intervention

Drug:
• utidelone injection
utidelone monotherapy in patients with advanced NSCLC by utidelone

Locations

Country	Name	City	State
China	Cancer Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing
China	Peking Union Hospital	Beijing	Beijing
China	Harbin Medical University Cancer Hospital	Harbin	Heilongjiang
China	Tianjin People's Hospital	Tianjin	Tianjin

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Biostar Pharmaceuticals Co., Ltd.	Chengdu Biostar Pharmaceuticals

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months from first study treatment
Secondary	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	1 year from first study treatment
Secondary	Overall survival (OS)	OS is defined as the duration of time from first study treatment until death from any cause.	2 year from enrolment
Secondary	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	1 year from first study treatment