Comparing Utidelone and Docetaxel for Advanced Lung Cancer

A Phase III, Open-label, Randomized, Controlled Clinical Study of Utidelone Versus Docetaxel in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Previously Failed Platinum-containing Chemotherapy Regimens

This study is testing whether a new drug called Utidelone works better than the standard treatment Docetaxel for people with advanced lung cancer who haven't responded to previous chemotherapy.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 612 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Beijing Biostar Pharmaceuticals Co., Ltd. (Industry-sponsored)
• Drugs / interventions: Erlotinib, Gefitinib, Icotinib, Afatinib, Osimertinib, Lorlatinib, chemotherapy, immunotherapy
• Locations: 1 site (Shanghai)
• Trial ID: NCT05673590 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to compare the efficacy and safety of Utidelone versus Docetaxel in patients with locally advanced or metastatic non-small cell lung cancer who have previously failed platinum-containing chemotherapy regimens. It is a phase III, open-label, randomized controlled trial involving 612 patients, who will be assigned in a 1:1 ratio to receive either Utidelone or Docetaxel. Treatment will continue in 21-day cycles until disease progression or intolerable side effects occur, with regular tumor assessments and quality of life evaluations conducted throughout the study.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with advanced non-small cell lung cancer who have previously received platinum-based chemotherapy.

Not a fit: Patients with early-stage lung cancer or those who have not received prior platinum-containing chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this trial could provide a new treatment option for patients with advanced lung cancer who have limited alternatives after failing previous therapies.

How similar studies have performed: Other studies have shown promise in using novel agents like Utidelone for treating advanced lung cancer, but this specific comparison is relatively novel.

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.

Where this trial is running

Shanghai

• Shanghai Pulmonary Hospital — Shanghai, China (Recruiting)

Study contacts

• Principal investigator: Caicun Zhou, MD — Shanghai Pulmonary Hospital, Shanghai, China
• Study coordinator: RONGGUO QIU, PhD

Conditions Locally Advanced or Metastatic Non-Small Cell Lung Cancer; Previously Failed, Platinum-Containing Chemotherapy Regimens