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Study of LY01610 in Patients With Recurrent Small Cell Lung Cancer

NCT06128837 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 686

Last updated 2024-03-15

No results posted yet for this study

Summary

This is a multicenter，randomized, open label, active-controlled, parallel-group study comparing efficacy and safety of LY01610(Irinotecan hydrochloride liposome Injection) and Topotecan in Patients with Recurrent Small Cell Lung Cancer (SCLC)

Conditions

  • Relapsed Small Cell Lung Cancer

Interventions

DRUG

Irinotecan hydrochloride liposome Injection

Irinotecan hydrochloride liposome Injection 80 mg/m² intravenously Days 1 q2wk

DRUG

Topotecan

Topotecan 1.2 mg/m² intravenously Days 1-5 q3w

Sponsors & Collaborators

  • Luye Pharma Group Ltd.

    lead INDUSTRY

Principal Investigators

  • yuankai shi, doctor · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-03-03
Primary Completion
2028-06-30
Completion
2028-10-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06128837 on ClinicalTrials.gov