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Trial Title:
Utidelone Versus Docetaxel in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
NCT ID:
NCT05673590
Condition:
Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Docetaxel
Conditions: Keywords:
Previously Failed, Platinum-Containing Chemotherapy Regimens
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Utidelone Injection
Description:
Pretreatment: diphenhydramine 40 mg by intramuscular injection or oral administration,
and dexamethasone10 mg and cimetidine 300 mg by intravenous injection 30 minutes prior to
Utidelone iv drip at the first day of each cycle. The dose of dexamethasone and
diphenhydramine can be halved by the physician based on patient's condition in the
following day through the fifth day in each cycle, as detailed in the protocol.
Dexamethasone 8 mg per oral, bid, one day prior to docetaxel iv drip for 3 days.
The treatment group will be treated with Utidelone Injection at 40 mg/m2/d intravenously
once daily on days 1-5 in a 21-day cycle until disease progression or an occurrence of
intolerable toxicities.
Arm group label:
The treatment group-Utidelone monotherapy
Intervention type:
Drug
Intervention name:
Docetaxel Injection
Description:
Pretreatment: Dexamethasone should be administered orally for 3 days at 16 mg per day (8
mg twice daily), starting one day before the start of Docetaxel.
The control group will be treated with Docetaxel Injection at 75 mg/m2/d, administered
intravenously once on day 1. Patients in this group will be treated in 21-day cycles
until disease progression or intolerable toxicities occurs.
Arm group label:
The control group-Docetaxel monotherapy
Summary:
The purpose of this clinical trial is to compare Utidelone with Docetaxel in patients
with locally advanced or metastatic non-small cell lung cancer previously failed
platinum-containing chemotherapy regimens. This phase III, open-label, randomized
controlled trial aims to evaluate and compare the efficacy and safety of Utidelone and
Docetaxel in the aforementioned lung cancers.
Detailed description:
In this study, 612 patients will be screened, enrolled and randomly assigned in a 1:1
ratio to either the Utidelone (40 mg/m2/d intravenously once daily on days 1-5) treatment
or the docetaxel (75 mg/m2/d, intravenously once on day 1) control group, stratified by
prior immunotherapy status (PD-1/PD-L1 vs. no PD-1/PD-L1). Both groups will be treated in
a 21-day cycle until disease progression or an occurrence of intolerable toxicities.
Tumor assessments will be performed at baseline and every 6 weeks (±7 days) after
randomization and continued until disease progression as assessed by RECIST v1.1
criteria, with or without discontinuation of study treatment; the EORTC QLQ-C30
questionnaire will be used to assess patients' quality of life based on a signed informed
consent.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patients must sign the informed consent form and commit to complying with the
requirements of this study.
2. Male or female, ≥ 18 years of age, ≤ 70 years of age.
3. Histologically or cytologically confirmed NSCLC, diagnosed as stage IV or stage
IIIB-IIIC not amenable to radical surgery according to the IASLC (International
Association for the Study of Lung Cancer) 8th edition staging system.
4. The subject has at least one evaluable lesion (measurable or non-measurable) by the
RECIST 1.1.
5. The subject must have received a prior systemic chemotherapy (including
neoadjuvant/adjuvant therapy) with a platinum-containing regimen, and are allowed to
have ≤ 2 prior lines of chemotherapy for advanced cancer (excluding
neoadjuvant/adjuvant chemotherapy).
6. Patients without driver genes can be treated with/ not be treated with PD-1/PD-L1
inhibitors previously.
7. EGFR-positive patients are required to have received at least one or more EGFR-TKI
(including Erlotinib, Gefitinib, Icotinib, Afatinib, Osimertinib, or other TKI for
EGFR mutations, etc.), with disease progression or intolerance during or after
treatment.
- Patients having had disease progression or intolerance to Osimertinib or other
third-generation EGFR-TKI are eligible for enrollment (regardless of prior
treatment with first/second-generation EGFR-TKI)
- Patients having had disease progression or intolerance to first- or
second-generation EGFR-TKI (e.g., Erlotinib, Gefitinib, Icotinib, Afatinib,
etc.) without evidence of EGFR T790M mutation after this treatment are eligible
for enrollment.
8. ALK fusion-positive patients who have received at least one or more ALK-TKI
therapies and experienced disease progression or intolerance during or after
treatment.
-Patients having had disease progression or intolerance to the third-generation
ALK-TKI Lorlatinib are eligible for enrollment (regardless of prior treatment with
first- or second-generation ALK-TKI).
9. Baseline routine blood tests within 1 week prior to enrollment is normal, with CTCAE
grade ≤1 (based on normal values at each site's laboratory). No rhG-CSF use and no
blood transfusion/EPO etc. within 14 days prior to enrollment.
- White blood cell count (WBC) ≥4.0 × 109/L.
- Neutrophil count (ANC) ≥ 1.5 × 109/L.
- platelet count (PLT) ≥ 100 × 109/L
- Hemoglobin ≥9.0 g/dL.
10. Blood biochemistry test result is normal within 1 week prior to enrollment, with
CTCAE grade ≤1 (based on normal values at each site's laboratory).
- Total bilirubin (TBIL) ≤ 1.5× the upper limit of normal value (ULN)
- Serum Glutamic Pyruvic Transaminase/Alanine Amino transferease (SGPT /ALT) ≤ 3×
ULN (in the case of liver metastases ≤ 5 × ULN)
- Serum Glutamic-oxaloacetic Transaminase/Aspartate Aminotransferase (SGOT /AST)
≤ 3× ULN (in the case of liver metastases ≤ 5 × ULN)
- Creatinine clearance (Ccr) ≥60 ml/min.
11. ECOG performance status 0-1.
12. Fertile males and females of childbearing potential must agree to use effective
contraception during the study and within 90 days after the last dose. The blood or
urine pregnancy test for female patients of childbearing age prior to enrollment
must be negative.
13. Patients with a life expectancy of more than 3 months.
Exclusion Criteria:
1. Patients who had other malignancies within the past 5 years, excluding cured basal
cell carcinoma of the skin, carcinoma in situ of the cervix, and papillary thyroid
cancer.
2. Patients who have received antitumor therapy, including chemotherapy, radiotherapy,
biologic therapy, targeted therapy, immunotherapy, or antitumor herbal therapy,
within 4 weeks or 5 half-lives (≥ 2 weeks), whichever is shorter, prior to the first
dose of the study drug.
3. Patients who have had surgery of their major organs (excluding puncture biopsy) or
had major injuries within 4 weeks prior to the first dose of study drug, or require
elective surgery during the study.
4. Patients with symptomatic peripheral neuropathy with CTCAE 5.0 grade ≥2
5. Patients with known allergic reactions to any ingredient of the study drug.
6. Patients who have previously been treated with docetaxel.
7. Patients who are pregnant (positive result from the pregnancy test) or lactating.
8. Patients whose prior adverse reactions to anti-tumor therapy have not recovered to
CTCAE 5.0 grade ≤1 (except for toxicity such as alopecia which poses no safety risk
in the judgment of the investigator).
9. Patients with symptomatic CNS metastases or meningeal metastases, or uncontrollable
metastases, i.e., metastatic lesion progression confirmed by examination within 2
months after radiotherapy or other localized treatment, or those who are unsuitable
for enrollment in the judgment of the investigator.
10. Patients with uncontrollable bone metastases, i.e., patients who have had fracture
or have the risk of fracture in recent days, patients who need surgery or localized
radiotherapy in recent days, and patients under critical conditions in the judgment
of the investigator.
11. Patients with uncontrollable pleural effusion, pericardial effusion, or ascites
requiring repeated drainage (once a month or more frequently)
12. Patients with an active infection that currently requires systemic anti-infective
therapy
13. Patients having a history of immunodeficiency, including a positive HIV antibody
test.
14. Patients with active hepatitis B/C infection; patients with known active infection
of syphilis.
15. Patients with history of severe cardiovascular disease, including but not limited
to:
- Serious cardiac rhythm or conduction abnormalities such as ventricular
arrhythmias requiring clinical intervention, second- to third- degree
atrioventricular block; mean QTcF >470ms from 3 12-lead ECGs at rest.
- Patients who had acute coronary syndrome, congestive heart failure, aortic
dissection, stroke or other cardiovascular events at Class 3 or higher within 6
months prior to the first dose.
- Patients with clinically uncontrollable hypertension.
- Patients with other high-risk cardiac conditions in the judgment of the
investigator.
16. Patients with uncontrolled diabetes mellitus.
17. Patients with mental disorders or poor compliance.
18. Patients who concurrently participate in another clinical trial or use another
investigational treatment.
19. Subjects who, in the opinion of the investigator, have a history of other serious
systemic diseases, or other reasons that make participation in this trial
inadvisable.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai Pulmonary Hospital
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Caicun Zhou
Start date:
May 12, 2023
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Beijing Biostar Pharmaceuticals Co., Ltd.
Agency class:
Industry
Source:
Beijing Biostar Pharmaceuticals Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05673590