drugset / Trial / NCT05299255

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

NCT05299255

Phase 2 Unknown 40 enrolled Henan Cancer Hospital
NaSingle-groupOpen-labelTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Epothilone D Small molecule 40 mg/m2