NCT04381910

Irinotecan Hydrochloride Liposome Injection (LY01610) For Small Cell Lung Cancer

A Phase Ⅱ Study Evaluate the Efficacy and Safety of LY01610（Irinotecan Hydrochloride Liposome Injection） in Patients With Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Luye Pharma Group Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a Multicenter, Non-randomized, Open Label, Multiple Dose, Multiple administration, Phase IIa Clinical Study Evaluating the Efficacy and Safety of LY01610 in Patients with Extensive-stage Small Cell Lung Cancer that Progressed after first-line Antitumor Therapy.

Detailed description

The objectives are to evaluate the efficacy and safety of LY01610 in subjects with extensive small cell lung cancer that progressed after first-line antitumor therapy. Patients were enrolled in one to three cohorts to receive LY01610 every 2 weeks, initial 30 subjects will be included in each cohort and the number of the cases could be adjusted. Subjects will receive LY01610 start with 60 mg/m2 every 2 weeks，when the sixth subjects of the current cohort completed 14 days safety observation of the first LY01610 administration, the investigators will evaluate the ongoing dose tolerance. If the investigator and the sponsor jointly believe that other doses can provide greater potential benefits for patients while ensuring safety and benefit, other appropriate cohorts could be explored (such as 80, 90 and 100 mg/m2, etc.) Subjects will receive the LY01610 monotherapy until occurrence of progressive disease (PD), death, intolerable toxicity reaction, withdrawal of informed consent, conduct of other antitumor therapy or completion of the whole study.

Conditions

• Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	LY01610( Irinotecan hydrochloride liposome injection )	LY01610 will be administered via intravenous infusion every 2 weeks on Day 1

Timeline

• Start date: 2020-09-28
• Primary completion: 2023-03-04
• Completion: 2023-03-04
• First posted: 2020-05-11
• Last updated: 2024-04-25

Locations

1 site across 1 country: China