Trial Title:
ARTEMIS-008：HS-20093 Compared With Topotecan in Subjects With Relapsed Small Cell Lung Cancer
NCT ID:
NCT06498479
Condition:
Small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Topotecan
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
HS-20093
Description:
HS-20093 will be administered as an IV infusion at dose of 8.0 mg/kg on Day 1 of each
21-day cycle.
Arm group label:
HS-20093
Intervention type:
Drug
Intervention name:
Topotecan
Description:
Topotecan will be administered per drug label.
Arm group label:
Topotecan
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-based regimen. Subjects will be randomized by a ratio of 1:1 to
receive HS-20093 or topotecan until disease progression.
The primary objective of this study is to assess whether treatment with HS-20093 prolongs
OS compared with treatment of topotecan among subjects with relapsed SCLC.
The secondary objectives of the study are to further evaluate the efficacy/safety of
HS-20093. The exploratory objectives are to characterize the pharmacokinetics of
HS-20093, evaluate E-R relationship, immunogenicity of HS-20093, B7-H3 protein expression
and soluble B7-H3 expression.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Country:
China
Status:
Not yet recruiting
Investigator:
Last name:
Jian Fang
Email:
Principal Investigator
Facility:
Name:
Harbin Medical University Cancer Hospital
Address:
City:
Harbin
Country:
China
Status:
Not yet recruiting
Investigator:
Last name:
Baogang Liu
Email:
Principal Investigator
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Country:
China
Status:
Not yet recruiting
Investigator:
Last name:
Qiming Liu
Email:
Principal Investigator
Facility:
Name:
Jilin Cancer Hospital
Address:
City:
Changchun
Country:
China
Status:
Recruiting
Contact:
Last name:
Ning Zhangning
Phone:
0431-80596067
Email:
JPCHIRB@163.com
Investigator:
Last name:
Ying Cheng
Email:
Principal Investigator
Facility:
Name:
Shengjing Hospital of China Medical University
Address:
City:
Shenyang
Country:
China
Status:
Not yet recruiting
Investigator:
Last name:
Wei Zheng
Email:
Principal Investigator
Facility:
Name:
Shandong Cancer Hospital
Address:
City:
Jinan
Country:
China
Status:
Not yet recruiting
Investigator:
Last name:
Haiyong Wang
Email:
Principal Investigator
Facility:
Name:
Shanghai Pulmonary Hospital
Address:
City:
Shanghai
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Peng Zhang
Investigator:
Last name:
Peng Zhang
Email:
Principal Investigator
Facility:
Name:
The First Affiliate Hospital of GUANGZHOU Medical University
Address:
City:
Guangzhou
Country:
China
Status:
Not yet recruiting
Investigator:
Last name:
Ming Liu
Email:
Principal Investigator
Facility:
Name:
Tongji Hospital
Address:
City:
Wuhan
Country:
China
Status:
Not yet recruiting
Investigator:
Last name:
Qian Chu
Email:
Principal Investigator
Start date:
July 4, 2024
Completion date:
May 31, 2027
Lead sponsor:
Agency:
Hansoh BioMedical R&D Company
Agency class:
Industry
Source:
Hansoh BioMedical R&D Company
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06498479
