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

NCT ID: NCT03693547

Last Updated: 2023-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-22
• Study Completion Date: 2021-08-10

Brief Summary

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

utidelone

Utidelone Injection: 30 mg/m2/day, IV on day 1-day 5 of each 21 day cycle, administered to enrolled patients with advanced NSCLC

Group Type: EXPERIMENTAL

utidelone injection

Intervention Type: DRUG

utidelone monotherapy in patients with advanced NSCLC by utidelone

Interventions

utidelone injection

utidelone monotherapy in patients with advanced NSCLC by utidelone

Intervention Type: DRUG

Other Intervention Names

UTD1 injection

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chengdu Biostar Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Beijing Biostar Pharmaceuticals Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

YUANKAI SHI, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, China

Locations

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Peking Union Hospital

Beijing, Beijing Municipality, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Tianjin People's Hospital

Tianjin, Tianjin Municipality, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 38601485 (View on PubMed)

Other Identifiers

BG01-1801

Identifier Type: -

Identifier Source: org_study_id