Actively Recruiting
ARTEMIS-008：HS-20093 Compared With Topotecan in Subjects With Relapsed Small Cell Lung Cancer
Led by Hansoh BioMedical R&D Company · Updated on 2024-10-16
460
Participants Needed
9
Research Sites
151 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
ARTEMIS-008：HS-20093 Compared With Topotecan in Subjects With Relapsed Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female subjects 18 years of age or older
- Histologically or cytologically confirmed small cell lung cancer
- Disease progression on or after first-line platinum-based chemotherapy
- At least one measurable lesion per RECIST 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Minimum life expectancy of more than 12 weeks
- Female subjects must not be pregnant at screening or have non-childbearing potential
- Use of adequate contraceptive measures throughout the study for men and women
- Informed consent provided prior to any study-specific procedures
You will not qualify if you...
- Combined small cell lung cancer or transformed SCLC to non-small cell lung cancer
- Chemotherapy-free interval of 30 days or less
- Prior treatment with anti-B7 homologue 3 (B7-H3) targeted agents
- Prior treatment with topoisomerase I inhibitors, including antibody-drug conjugates containing topoisomerase I inhibitors
- Inadequate washout period before randomization as specified
- Untreated or symptomatic brain metastases except as defined
- Unresolved toxicity from prior anti-tumor therapy above grade 1 except as defined
- History of other malignancies except as defined
- Inadequate bone marrow or organ function
- Evidence of cardiovascular risks or severe uncontrolled cardiovascular diseases
- Severe or uncontrolled diabetes or high blood pressure
- Significant bleeding or bleeding tendency within 1 month prior to randomization
- Severe arterial or venous thromboembolic events within 3 months prior to randomization
- Severe infections within 4 weeks before randomization
- Systemic corticosteroid therapy within 30 days prior to randomization except as defined
- Active infectious diseases before randomization
- Current hepatic encephalopathy, hepatorenal syndrome, or severe liver cirrhosis
- History of interstitial lung disease, immunotherapy-induced pneumonitis, or moderate to severe pulmonary disease
- History of severe neuropathy or mental disorders
- Female subjects who are breastfeeding or planning pregnancy during the study
- Vaccination or hypersensitivity within 4 weeks before randomization
- Severe hypersensitivity or infusion reactions to human or mouse proteins
- Hypersensitivity to any ingredient of HS-20093, DNA topoisomerase I inhibitor, or topotecan regimens
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Not Yet Recruiting
2
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Not Yet Recruiting
3
Henan Cancer Hospital
Zhengzhou, Henan, China
Not Yet Recruiting
4
Jilin Cancer Hospital
Changchun, Jilin, China
Actively Recruiting
5
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
Not Yet Recruiting
6
Shandong Cancer Hospital
Jinan, Shandong, China
Not Yet Recruiting
7
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
Not Yet Recruiting
8
The First Affiliate Hospital of GUANGZHOU Medical University
Guangzhou, China
Not Yet Recruiting
9
Tongji Hospital
Wuhan, China
Not Yet Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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