Clinical trial NCT03693547: Clinical Study of Utidelone Injection in Patients With Advanced Non-small Cell Lung Cancer（NSCLC）
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Advanced Non-small Cell Lung Cancer
Lead sponsor: Beijing Biostar Pharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Chengdu Biostar Pharmaceuticals
First posted: 2018-10-03
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Tumor response to utidelone treatment
timeFrame: 6 months from first study treatment
Secondary outcomes:
measure: Progression free survival (PFS)
timeFrame: 1 year from first study treatment
measure: Overall survival (OS)
timeFrame: 2 year from enrolment
measure: Incidence of treatment-emergent adverse events based the Common Terminology Criteria for Adverse Events (CTCAE) version 4·03
timeFrame: 1 year from first study treatment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital, Chinese Academy of Medical Sciences
state: Beijing
city: Beijing
country: China
facility: Peking Union Hospital
state: Beijing
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Tianjin
country: China
facility: Tianjin People's Hospital
state: Tianjin
Study officials:
affiliation: National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, China
name: YUANKAI SHI, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: