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

NCT05299255 | Unknown Phase 2 DMC

• 1 other identifier: HXNI-YTDL-001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

small cell lung cancer,Utidelone

Outcome Measures

Primary Outcomes (1)

• The objective response rate (ORR) according to the RECIST 1.1

  the objective response rate (ORR）of utidelone in the third-Line and above treatment of ES-SCLC

  24 weeks

Study Arms (1)

Utidelone vs placebo

EXPERIMENTAL

Drug: Utidelone vs placebo in Third-line and above Treatment Extensive Small-cell Lung Cancer

Drug: Utidelone; Drug: Placebo

Interventions

Utidelone DRUG

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

Utidelone vs placebo

Placebo DRUG

the placebo as control group.

Utidelone vs placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnancy (positive pregnancy test) or lactating patients;
• Patients with active pulmonary tuberculosis;
• Patients with high suspicion of interstitial lung disease;
• 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.

Sponsors & Collaborators

• Henan Cancer Hospital: lead

Study Sites (1)

Henan Tumor Hospital

Zhengzhou, Henan, 450000, China

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

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

Study Officials

• Yanqiu Zhao, MS

  Henan Tumor Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanqiu Zhao, MS

CONTACT

13938252350; 13938252350@163.com

Baoxia He, MS

CONTACT

0371-65587418; hnszlyygcp@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Oncology

Study Record Dates

• First Submitted: March 8, 2022
• First Posted: March 28, 2022
• Study Start: September 5, 2021
• Primary Completion: September 5, 2022
• Study Completion: September 5, 2023
• Last Updated: March 28, 2022

Record last verified: 2022-03

Locations

CN (1)