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

NCT03693547 | Completed Phase 2

• 1 other identifier: BG01-1801
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 4

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Progression free survival (PFS)

  1 year from first study treatment

• Overall survival (OS)

  2 year from enrolment

• Incidence of treatment-emergent adverse events based the Common Terminology Criteria for Adverse Events (CTCAE) version 4·03

  1 year from first study treatment

Study Arms (1)

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

Drug: utidelone injection

Interventions

utidelone injection DRUG

utidelone monotherapy in patients with advanced NSCLC by utidelone

Also known as: UTD1 injection

utidelone

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Biostar Pharmaceuticals Co., Ltd.: lead
• Chengdu Biostar Pharmaceuticals: collaborator

Study Sites (4)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

Peking Union Hospital

Beijing, Beijing Municipality, China

Location

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150081, China

Location

Tianjin People's Hospital

Tianjin, Tianjin Municipality, China

Location

Related Publications (1)

• 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.

  PMID: 38601485 DERIVED

Study Officials

• YUANKAI SHI, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2018
• First Posted: October 3, 2018
• Study Start: April 22, 2019
• Primary Completion: June 25, 2021
• Study Completion: August 10, 2021
• Last Updated: January 10, 2023

Record last verified: 2023-01

Locations

CN (4)