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

Recruiting now · Phase 3

Conditions studied: Small Cell Lung Cancer

In brief

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 facts

Study ID

NCT06498479

Run by

Hansoh BioMedical R&D Company

People needed

460

Starts

2024-07-04

Expected to finish

2027-05-31

Last updated by the study team

2024-10-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• Combined SCLC, any previous diagnosis of transformed SCLC or SCLC that has transformed to NSCLC.
• Chemotherapy-free interval ≤30 days.
• Has received prior treatment with anti-B7 homologue 3 (B7-H3) targeted agents.
• Has received prior treatment with topoisomerase I inhibitor, including ADC that consists of topoisomerase I inhibitor.
• Has inadequate washout period before randomization as specified in the protocol.
• Untreated or symptomatic brain metastases with exceptions defined in the protocol.
• 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.
• History of other malignancy with exceptions defined in the protocol.
• Inadequate bone marrow reserve or organ dysfunction.
• Evidence of cardiovascular risks.
• Severe, uncontrolled or active cardiovascular diseases.
• Severe or uncontrolled diabetes.
• Severe or uncontrolled high blood pressure.
• Clinically significant bleeding or obvious bleeding tendency within 1 month before randomization.
• Severe arterial or venous thromboembolic events within 3 months prior to randomization.
• Severe infections within 4 weeks before randomization.
• Receiving systemic corticosteroid therapy within 30 days prior to randomization with exceptions defined in the protocol.
• The presence of active infectious diseases before randomization.
• Current hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh Grade B or more severe cirrhosis.
• History of interstitial lung disease, immunotherapy-induced pneumonitis, clinically moderate or severe pulmonary disease.
• History of severe neuropathy or mental disorders.
• Female subjects of childbearing potential; female subjects who are breastfeeding or who plan to breastfeed while on study; female subjects planning to become pregnant while on study.
• Vaccination or hypersensitivity of any level within 4 weeks before randomization.
• History of severe hypersensitivity reaction, severe infusion reaction or allergy to recombinant human or mouse derived proteins.
• Hypersensitivity to any ingredient of HS-20093, DNA topoisomerase I inhibitor or regimens of Topotecan.

Where it is running

• Jilin Cancer Hospital — Changchun, Jilin, China (enrolling)
• Harbin Medical University Cancer Hospital — Harbin, Heilongjiang, China
• Henan Cancer Hospital — Zhengzhou, Henan, 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
• Beijing Cancer Hospital — Beijing, Beijing Municipality, China
• Tongji Hospital — Wuhan, China

Full record on ClinicalTrials.gov

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