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

NCT05299255 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-03-28

No results posted yet for this study

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.

Conditions

  • SCLC, Extensive Stage

Interventions

DRUG

Utidelone

Utidelone Versus placebo in Third-line and above treatment of Extensive Small-cell Lung Cancer

DRUG

Placebo

the placebo as control group.

Sponsors & Collaborators

  • Henan Cancer Hospital

    lead OTHER_GOV

Principal Investigators

  • Yanqiu Zhao, MS · Henan Tumor Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-05
Primary Completion
2022-09-05
Completion
2023-09-05

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05299255 on ClinicalTrials.gov