NCT03769935

Maintenance Therapy for Small-cell Lung Cancer

Preliminary Study of Maintenance Therapy for Patients With Extensive Stage of Small-cell Lung Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Qingdao Central Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study involves patients treated with cisplatin and etoposide (induction therapy), followed by treatment with a drug called S1 (maintenance therapy). The main purpose of this study is to determine if this type of treatment will delay the growth of the tumor and if so, for how long. The primary endpoint is progression free survival and second endpoints are toxicities, overall survival.

Detailed description

Small cell lung cancer (SCLC) accounts for about 20% of lung cancer, has a high degree of malignancy, short doubling time, early and widespread metastasis, is sensitive to chemotherapy and radiotherapy, and has a high initial response rate, but is prone to secondary drug resistance and relapse. The treatment is mainly based on systemic chemotherapy, and if maintenance therapy with S1 after standard EP regimen induction therapy could prolong progression free survival.

Conditions

• Progression Free Survival

Interventions

Type	Name	Description
DRUG	cis Platinum, etoposide, S1	cisplatin 75 mg/m2, iv day1, Etoposide: 60 mg/m2 IV day 1-5, every 21 days for up to 4-6 cycles. S1 25 mg/m2 oral, everyday until progression disease

Timeline

• Start date: 2017-01-01
• Primary completion: 2022-01-01
• Completion: 2022-07-01
• First posted: 2018-12-10
• Last updated: 2023-03-29

Locations

1 site across 1 country: China