ARTEMIS-008：HS-20093 Compared With Topotecan in Subjects With Relapsed Small Cell Lung Cancer

NCT06498479 | Recruiting Phase 3 FDA Drug

• 1 other identifier: HS-20093-301
• Study Type: interventional
• Target: 460
• Locations: 1 country
• Sites: 9

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).

Conditions

Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Overall survival

  Overall survival is defined as the time interval from randomization to death due to any cause.

  From the date of randomization to the date of death due to any cause; Up to approximately 4.5 years

Secondary Outcomes (5)

• Objective Response Rate (ORR) Assessed by Blinded Independent Central Review and Investigators

  From the date of randomization to documented progressive disease, death, lost to follow-up, or withdrawal by the participant; Up to approximately 4.5 years.

• Disease Control Rate (DCR) Assessed by Blinded Independent Central Review and Investigator

  From the date of randomization to documented progressive disease, death, lost to follow-up, or withdrawal by the participant; Up to approximately 4.5 years.

• Duration of Response Assessed by Blinded Independent Central Review and Investigator

  From the date of first documentation of confirmed response (CR or PR) to the first documentation of objective progression or to death due to any cause, whichever occurs first; Up to approximately 4.5 years.

• Progression-free Survival Assessed by Blinded Independent Central Review and Investigator

  From the date of randomization to documented progressive disease, death, lost to follow-up, or withdrawal by the participant; Up to approximately 4.5 years.

• Incidence and Grade of Participants With Treatment-emergent Adverse Events

  From the date of first dose to the end of safety follow-up; Up to approximately 4.5 years.

Study Arms (2)

HS-20093

EXPERIMENTAL

Participants will receive HS-20093 as an intravenous (IV) infusion at dose of 8.0 mg/kg on Day 1 of each 21-day cycle until a treatment discontinuation criterion is met as specified in the protocol.

Drug: HS-20093

Topotecan

ACTIVE COMPARATOR

Participants will receive topotecan until a treatment discontinuation criterion is met as specified in the protocol.

Drug: Topotecan

Interventions

HS-20093 DRUG

HS-20093 will be administered as an IV infusion at dose of 8.0 mg/kg on Day 1 of each 21-day cycle.

HS-20093

Topotecan DRUG

Topotecan will be administered per drug label.

Topotecan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hansoh BioMedical R&D Company: lead

Study Sites (9)

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

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Topotecan

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2024
• First Posted: July 12, 2024
• Study Start: July 4, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): May 31, 2027
• Last Updated: October 16, 2024

Record last verified: 2024-10

Locations

CN (9)