Utidelone Versus Docetaxel in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

NCT05673590 | Unknown Phase 3

• 1 other identifier: BG01-2101
• Study Type: interventional
• Target: 612
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Keywords

Previously Failed, Platinum-Containing Chemotherapy Regimens

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  Comparing the OS of Utidelone and Docetaxel for locally advanced or metastatic non-small cell lung cancer patients who previously failed Platinum-containing chemotherapy regimens

  36 months

Secondary Outcomes (3)

• Progression Free Survival

  36 months

• Objective Response Rate

  36 months

• Clinical Benefit Rate

  36 months

Study Arms (2)

The treatment group-Utidelone monotherapy

EXPERIMENTAL

Drug: Utidelone Injection Dose: 40 mg/m2/d intravenously Regimen: once daily on days 1-5 in a 21-day cycle

Drug: Utidelone Injection

The control group-Docetaxel monotherapy

ACTIVE COMPARATOR

Drug: Docetaxel Injection Dose:75 mg/m2/d, administered intravenously Regimen: once on day 1 in a 21-day cycle

Drug: Docetaxel Injection

Interventions

Utidelone Injection DRUG

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.

The treatment group-Utidelone monotherapy

Docetaxel Injection DRUG

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.

The control group-Docetaxel monotherapy

Eligibility Criteria

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

You may qualify if:

• Patients must sign the informed consent form and commit to complying with the requirements of this study.
• Male or female, ≥ 18 years of age, ≤ 70 years of age.
• 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.
• The subject has at least one evaluable lesion (measurable or non-measurable) by the RECIST 1.1.
• 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).
• Patients without driver genes can be treated with/ not be treated with PD-1/PD-L1 inhibitors previously.
• 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.
• 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).
• 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

You may not qualify if:

• 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.
• 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.
• 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.
• Patients with symptomatic peripheral neuropathy with CTCAE 5.0 grade ≥2
• Patients with known allergic reactions to any ingredient of the study drug.
• Patients who have previously been treated with docetaxel.
• Patients who are pregnant (positive result from the pregnancy test) or lactating.
• 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).
• 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.
• 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.
• Patients with uncontrollable pleural effusion, pericardial effusion, or ascites requiring repeated drainage (once a month or more frequently)
• Patients with an active infection that currently requires systemic anti-infective therapy
• Patients having a history of immunodeficiency, including a positive HIV antibody test.
• Patients with active hepatitis B/C infection; patients with known active infection of syphilis.
• Patients with history of severe cardiovascular disease, including but not limited to:

Sponsors & Collaborators

• Beijing Biostar Pharmaceuticals Co., Ltd.: lead

Study Sites (1)

Shanghai Pulmonary Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Caicun Zhou, MD

  Shanghai Pulmonary Hospital, Shanghai, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

RONGGUO QIU, PhD

CONTACT

01186-56315388; rqiu2001@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2022
• First Posted: January 6, 2023
• Study Start: May 12, 2023
• Primary Completion: June 15, 2025
• Study Completion: December 31, 2025
• Last Updated: November 8, 2023

Record last verified: 2022-12

Locations

CN (1)