Clinical trial · Interventional
A Study of HS-20093 vs Active Surveillance in Limited-Stage Small Cell Lung Cancer
ARTEMIS-009: A Phase 3, Randomized, Controlled, Multi-center, Open-label Study of HS-20093 Versus Active Surveillance As Consolidation Therapy After Chemoradiotherapy in Subjects With Limited-Stage Small Cell Lung Cancer
NCT06526624CI-TRIAL-00079225not yet recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will evaluate the efficacy, safety and tolerability of HS-20093 compared with active surveillance as consolidation therapy after chemoradiotherapy in participants with limited-stage small cell lung cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Limited-stage Small-cell Lung Cancer | Lung Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HS-20093 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- HS-20093
- description
- Patients with LS-SCLC who have not progressed following CRT. Patients in this arm will be administrated HS-20093 intravenously at a dose of 8.0 mg/kg, Q3W continuously until disease progression or until other criteria for discontinuation of treatment are met.
- interventionNames
- Drug: HS-20093
- type
- NO_INTERVENTION
- label
- Active surveillance
- description
- Patients with LS-SCLC who have not progressed following CRT. Patients in this arm will receive active surveillance until disease progression or until other criteria for discontinuation of active surveillance are met.
Primary outcomes (2)
- measure
- Progression-free survival (PFS) According to RECIST v1.1 by Independent Review Committee (IRC)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Have signed Informed Consent Form. 2. Males or females ≥18 years old. 3. Patients with limited-stage SCLC who are deemed unsuitable for surgery or decline surgery. 4. ECOG performance status of 0-1. 5. Patients who have received CRT and have not progressed. 6. Minimum life expectancy \> 12 weeks. 7. Males or Females should be using adequate contraceptive measures throughout the study. 8. Females must not be pregnant at screening or have evidence of non-childbearing potential. Exclusion Criteria: 1. Patients with mixed SCLC or NSCLC or sarcoma-like carcinoma, or large cell neuroendocrine carcinoma. 2. Patients with extensive-stage SCLC. 3. Disease progression during CRT or before randomization. 4. Received or are receiving the following treatments: 1. For LS-SCLC, prior treatment with or current use of other chemotherapy regimens other than platinum plus etoposide 2. Received any other anti-cancer treatment. 3. Previous or current treatment with B7-H3 target therapy. 4. Traditional Chinese medicine indicated for tumors within 2 weeks prior to the first dose of study drug. 5. Major surgery within 4 weeks prior to the first dose of study drug. 5. Interstitial lung disease (ILD)/non-infectious pneumonitis. 6. History of other primary malignancies. 7. Inadequate bone marrow reserve or organ functions. 8. Severe, uncontrolled or active cardiovascular disorders. 9. Severe or uncontrolled diabetes. 10. Serious or poorly controlled hypertension. 11. Severe bleeding symptoms or bleeding tendencies within 1 month prior to randomization. 12. Severe arteriovenous thrombosis occurred within 3 months prior to randomization. 13. Serious infection within 4 weeks prior to randomization. 14. Presence of Grade ≥ 2 toxicities due to prior anti-tumor therapy. 15. Having serious neurological or mental disorders. 16. History of hypersensitivity to any component of HS-200093 or its similar drugs. 17. Participants with any condition that compromises the safety of the participant or interferes with the assessment of the study, as judged by the investigator.
References
Publications (0)
Data not yet available
No reference posted for this study.