Comparing HS-20093 with Topotecan for 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

This study is testing a new drug called HS-20093 against the standard treatment topotecan to see which one works better for people with relapsed small cell lung cancer.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 460 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hansoh BioMedical R&D Company (industry)
• Drugs / interventions: Chemotherapy, immunotherapy
• Locations: 9 sites (Beijing, Beijing Municipality and 8 other locations)
• Trial ID: NCT06498479 on ClinicalTrials.gov

What this trial studies

This phase 3, randomized, open-label study aims to evaluate the efficacy of HS-20093 compared to the standard treatment, topotecan, in patients with relapsed small cell lung cancer (SCLC) who have experienced disease progression after first-line platinum-based therapy. Participants will be randomly assigned to receive either HS-20093 or topotecan until their disease progresses. The study will assess overall survival as the primary endpoint, while also examining the safety and pharmacokinetics of HS-20093 as secondary and exploratory objectives.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed relapsed small cell lung cancer who have progressed after first-line platinum-based chemotherapy.

Not a fit: Patients with combined SCLC or those who have previously received treatment with anti-B7 homologue 3 agents or topoisomerase I inhibitors may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new option for prolonging survival in patients with relapsed small cell lung cancer.

How similar studies have performed: While there have been studies on treatments for small cell lung cancer, the specific approach of HS-20093 is novel and has not been extensively tested in this context.

Eligibility criteria

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.
11. Severe, uncontrolled or active cardiovascular diseases.
12. Severe or uncontrolled diabetes.
13. Severe or uncontrolled high blood pressure.
14. Clinically significant bleeding or obvious bleeding tendency within 1 month before randomization.
15. Severe arterial or venous thromboembolic events within 3 months prior to randomization.
16. Severe infections within 4 weeks before randomization.
17. Receiving systemic corticosteroid therapy within 30 days prior to randomization with exceptions defined in the protocol.
18. The presence of active infectious diseases before randomization.
19. Current hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh Grade B or more severe cirrhosis.
20. History of interstitial lung disease, immunotherapy-induced pneumonitis, clinically moderate or severe pulmonary disease.
21. History of severe neuropathy or mental disorders.
22. 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.
23. Vaccination or hypersensitivity of any level within 4 weeks before randomization.
24. History of severe hypersensitivity reaction, severe infusion reaction or allergy to recombinant human or mouse derived proteins.
25. Hypersensitivity to any ingredient of HS-20093, DNA topoisomerase I inhibitor or regimens of Topotecan.

Where this trial is running

Beijing, Beijing Municipality and 8 other locations

• Beijing Cancer Hospital — Beijing, Beijing Municipality, China (NOT_YET_RECRUITING)
• Harbin Medical University Cancer Hospital — Harbin, Heilongjiang, China (NOT_YET_RECRUITING)
• Henan Cancer Hospital — Zhengzhou, Henan, China (NOT_YET_RECRUITING)
• Jilin Cancer Hospital — Changchun, Jilin, China (RECRUITING)
• Shengjing Hospital of China Medical University — Shenyang, Liaoning, China (NOT_YET_RECRUITING)
• Shandong Cancer Hospital — Jinan, Shandong, China (NOT_YET_RECRUITING)
• Shanghai Pulmonary Hospital — Shanghai, Shanghai Municipality, China (NOT_YET_RECRUITING)
• The First Affiliate Hospital of GUANGZHOU Medical University — Guangzhou, China (NOT_YET_RECRUITING)
• Tongji Hospital — Wuhan, China (NOT_YET_RECRUITING)

Conditions: Small Cell Lung Cancer