Study of LY01610 in Patients With Recurrent Small Cell Lung Cancer

Sponsor
Luye Pharma Group Ltd.
Study ID
NCT06128837
Phase
PHASE3
Status
Recruiting
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Conditions

  • Relapsed Small Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

Study Details

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)

Key Dates

Start date
Mar 3, 2024
Status verified
Mar 2024
Primary completion
Jun 30, 2028
Completion
Oct 31, 2028

Study Design

Enrollment
686 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: LY01610
    Patients will consecutively receive LY01610 on Day 1 q2wk (every two weeks = one treatment cycle)
  • Active Comparator: Topotecan
    Patients will consecutively receive Topotecan on Days 1-5 q3wk(every three weeks = one treatment cycle)

Primary Outcome Measure

Overall survival (OS) [ Time Frame: From the date of randomization to the date of death or last contact, whichever occurs first, assessed up to 52 month ]

Central Contacts

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