RecruitingPhase 3NCT06498479

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

ARTEMIS-008:A Multicenter, Randomized, Open-label, Phase 3 Study of HS-20093 Compared With Topotecan in Subjects With Relapsed Small Cell Lung Cancer After Platinum-based First-line Chemotherapy


Sponsor

Hansoh BioMedical R&D Company

Enrollment

460 participants

Start Date

Jul 4, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (ARTEMIS-008) is comparing a new drug called HS-20093 to the standard chemotherapy drug topotecan in people with small cell lung cancer (SCLC) that has come back after initial treatment. **You may be eligible if...** - You are 18 or older with confirmed small cell lung cancer - Your cancer has progressed after at least one round of platinum-based chemotherapy - You have at least one measurable tumor on imaging - Your general health score (ECOG) is 0 or 1 and estimated survival is more than 12 weeks - You are not pregnant and are using contraception if applicable **You may NOT be eligible if...** - You have not previously received platinum-based chemotherapy for SCLC - You have active brain metastases that are untreated - You have serious heart conditions or are on medications that interact with the study drugs - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHS-20093

HS-20093 will be administered as an IV infusion at dose of 8.0 mg/kg on Day 1 of each 21-day cycle.

DRUGTopotecan

Topotecan will be administered per drug label.


Locations(9)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Jilin Cancer Hospital

Changchun, Jilin, China

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

Shandong Cancer Hospital

Jinan, Shandong, China

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

The First Affiliate Hospital of GUANGZHOU Medical University

Guangzhou, China

Tongji Hospital

Wuhan, China

View Full Details on ClinicalTrials.gov

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NCT06498479


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