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

Sponsor
Luye Pharma Group Ltd.
Study ID
NCT04381910
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Sep 28, 2020
Status verified
Apr 2024
Primary completion
Mar 4, 2023
Completion
Mar 4, 2023

Study Design

Enrollment
66 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: LY01610
    LY01610(Irinotecan Hydrochloride Liposome Injection),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.

Primary Outcome Measure

Objective Response Rate(ORR) [ Time Frame: from the date of randomisation to the date of disease progression or death up to 12 months from randomisation of the last subject ]

Related Studies