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RECRUITINGPHASE3

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

NCT06498479•Hansoh BioMedical R&D Company

View on ClinicalTrials.gov

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).

Detailed Description

This is a phase 3, randomized, open-label, multicenter study comparing HS-20093 with topotecan in patients with limited or extensive SCLC that had disease progression on or after first-line platinum-based regimen. Subjects will be randomized by a ratio of 1:1 to receive HS-20093 or topotecan until disease progression. The primary objective of this study is to assess whether treatment with HS-20093 prolongs OS compared with treatment of topotecan among subjects with relapsed SCLC. The secondary objectives of the study are to further evaluate the efficacy/safety of HS-20093. The exploratory objectives are to characterize the pharmacokinetics of HS-20093, evaluate E-R relationship, immunogenicity of HS-20093, B7-H3 protein expression and soluble B7-H3 expression.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or female subjects ≥18 years of age.
•2. Histologically or cytologically confirmed SCLC.
•3. Subjects who progressed on or after first-line platinum-based regimens.
•4. Has at least 1 measurable lesion as defined per RECIST 1.1.
•5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
•6. Minimum life expectancy of more than 12 weeks.
•7. Females subjects must not be pregnant at screening or have evidence of non-childbearing potential.
•8. Men or women should be using adequate contraceptive measures throughout the study.
•9. Subject has provided informed consent/assent prior to initiation of any study specific activities/procedures.

Exclusion Criteria

•1. Combined SCLC, any previous diagnosis of transformed SCLC or SCLC that has transformed to NSCLC.
•2. Chemotherapy-free interval ≤30 days.
•3. Has received prior treatment with anti-B7 homologue 3 (B7-H3) targeted agents.
•4. Has received prior treatment with topoisomerase I inhibitor, including ADC that consists of topoisomerase I inhibitor.
•5. Has inadequate washout period before randomization as specified in the protocol.
•6. Untreated or symptomatic brain metastases with exceptions defined in the protocol.
•7. Unresolved toxicity from prior anti-tumor therapy, defined as not having resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade 1 with exceptions defined in the protocol.
•8. History of other malignancy with exceptions defined in the protocol.
•9. Inadequate bone marrow reserve or organ dysfunction.
•10. Evidence of cardiovascular risks.
+15 more criteria

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

Key Dates

Start Date

July 4, 2024

Primary Completion Date

September 30, 2026

Completion Date

May 31, 2027

Last Updated

October 16, 2024

Enrollment

460

ESTIMATED participants

Conditions

Small Cell Lung Cancer

Interventions

HS-20093

DRUG

Topotecan

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 16, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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