ARTEMIS-008：HS-20093 Compared With Topotecan in Subjects With Relapsed Small Cell Lung Cancer

Sponsor
Hansoh BioMedical R&D Company
Study ID
NCT06498479
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • HS-20093 — DRUG
    HS-20093 will be administered as an IV infusion at dose of 8.0 mg/kg on Day 1 of each 21-day cycle.
  • Topotecan — DRUG
    Topotecan will be administered per drug label.

Study Details

The main objective of this study is to compare the efficacy of HS-20093 with standard of care (SOC) on prolonging overall survival (OS) in subjects with relapsed small cell lung cancer (SCLC).

Key Dates

First listed
Jul 12, 2024
Start date
Jul 4, 2024
Status verified
Oct 2024
Primary completion
Sep 30, 2026
Completion
May 31, 2027

Study Design

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

Arms

  • Experimental: HS-20093
    Participants will receive HS-20093 as an intravenous (IV) infusion at dose of 8.0 mg/kg on Day 1 of each 21-day cycle until a treatment discontinuation criterion is met as specified in the protocol.
  • Active Comparator: Topotecan
    Participants will receive topotecan until a treatment discontinuation criterion is met as specified in the protocol.

Primary Outcome Measure

Overall survival [ Time Frame: From the date of randomization to the date of death due to any cause; Up to approximately 4.5 years ]

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