Utidelone in Third-line and Above Treatment of Small Cell Lung Cancer

  • STATUS
    Recruiting
  • End date
    Sep 5, 2023
  • participants needed
    40
  • sponsor
    Henan Cancer Hospital
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Updated on 10 April 2022
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Summary

SCLC has a very high degree of malignancy, and 60% to 70% of patients are diagnosed as extensive stage. The median survival of patients with limited-stage disease is about 15-20 months, and the median OS of patients with extensive-stage disease is about 8-13 months, and the 2-year and 5-year survival rates are about 5% and 1-2%, respectively. However, although the initial treatment has a high effective rate, most patients relapse or progress within 1 year, and the effect of re-treatment is poor and the prognosis is poor. The effective rate of SCLC second-line treatment is only 10-25%, and the median survival time is less than 6 months. After the third and fourth lines, there are almost no recognized treatment options. Therefore, improving the second-line treatment of SCLC has always been a difficult clinical problem, and new drugs are urgently needed to be explored. In small cell lung cancer, based on phase II clinical trials, paclitaxel is currently recommended by NCCN guidelines for subsequent systemic therapy in patients who relapse 6 months or less after initial therapy. Utidelone (UTD1) is an epothilone derivative with a similar mechanism of action to taxanes, but a completely different molecular structure.

Description

Compared with paclitaxel, epothilones has higher water solubility and toxicity tolerance, and fewer side effects, these findings suggest that utidron may have better antitumor activity against small cell lung cancer. Therefore, to prospectively observe the treatment of extensive-stage small cell lung cancer with failure of second-line or above chemotherapy and receive Utilidron, so as to understand the efficacy, safety and tolerability of Utilidron in the third-line and above treatment of small cell lung cancer, which is a small Post-line treatment of cell lung cancer provides new directions and treatment options.

This study is an open, single-center phase II clinical study. Small cell lung cancer patients with disease progression or recurrence after second-line therapy or above, receive Utilidron injection. Utilidron injection 40mg/m2/d d1-5 q3w was administered until disease progression (PD), intolerable toxicity, initiation of new antitumor therapy, loss to follow-up, death, and the investigator decided to be tested Subjects who withdraw from the study treatment or the subject/their legal representative requests to withdraw from the study (whichever occurs first). After consultation with the sponsor, the patient will determine whether the treatment can be continued, observe and evaluate the preliminary efficacy and safety.

Details
Condition SCLC, Extensive Stage
Treatment Placebo, Utidelone
Clinical Study IdentifierNCT05299255
SponsorHenan Cancer Hospital
Last Modified on10 April 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Histologically diagnosed small cell lung cancer (except for small cell lung cancer mixed with other pathological types)
The expected survival period is not less than 3 months
Second-line therapy (excluding maintenance therapy) and above with disease progression or recurrence of small cell lung cancer
Patients who have not received chemotherapy, radiotherapy, surgery, targeted therapy and immunotherapy within 4 weeks before enrollment
Age 18-75 years old, physical condition score ECOG 0-1 points
At least one target lesion measurable by imaging within 3 weeks before enrollment, ordinary CT scan ≥ 20 mm, spiral CT scan diameter ≥ 10 mm (lymph node short diameter ≥ 15 mm)
Asymptomatic brain metastases, or patients with stable disease for more than 4 weeks after brain metastases treatment
Neurological lesions should be less than grade 2 within 4 weeks before enrollment (NCI CTC4.03)
Routine blood and blood biochemical tests were basically normal within 1 week before enrollment (based on the normal value of the research center laboratory, no blood transfusion within 14 days before screening, and no rhG-CSF was used)
Blood routine: HGB≥9g/dL; ANC≥1.5×109/L; PLT≥80×109/L; Blood biochemistry (without ALB
infusion within 14 days): bilirubin <1.5 times the upper limit of normal, ALT and AST ≤2.5
times the upper limit of normal (if liver metastases exist, bilirubin ≤3 times the upper
limit of normal, ALT and AST≤3 times the upper limit of normal) 5 times the upper limit of
normal), serum Cr≤1.5 times the upper limit of normal or endogenous creatinine clearance
≥45 mL/min (Cockcroft-Gault formula)
Those who have no major organ dysfunction and no concomitant heart disease
Females of childbearing age, including those who are in menopause but have not reached
postmenopausal state (natural amenorrhea for 12 consecutive months) and who have not
received sterilization and ovarian and/or hysterectomy, must have a blood pregnancy
test within 7 days before the first

Exclusion Criteria

Pregnancy (positive pregnancy test) or lactating patients
Patients with active pulmonary tuberculosis
Patients with high suspicion of interstitial lung disease
Exclusion criteria for combined diseases
Cancerous meningitis patients
patients with symptomatic central nervous system (CNS) metastasis
Other active malignant tumors that require concurrent treatment, but
not including carcinoma in situ of the cervix or basal cell carcinoma
of the skin
Patients with serious diseases, including severe heart disease
cerebrovascular disease, uncontrolled diabetes, uncontrolled
hypertension, severe infection, active peptic ulcer, and those
with a history of mental illness that is not easy to control
HIV positive test results, untreated active hepatitis patients
Patients with poor compliance; The investigators believe that those who are not
suitable to participate in this trial
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