Status:
RECRUITING
ARTEMIS-008：HS-20093 Compared With Topotecan in Subjects With Relapsed Small Cell Lung Cancer
Lead Sponsor:
Hansoh BioMedical R&D Company
Conditions:
Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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-b...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
July 4 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2027
Estimated Enrollment :
460 Patients enrolled
Trial Details
Trial ID
NCT06498479
Start Date
July 4 2024
End Date
May 31 2027
Last Update
October 16 2024
Active Locations (9)
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1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
2
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
3
Henan Cancer Hospital
Zhengzhou, Henan, China
4
Jilin Cancer Hospital
Changchun, Jilin, China