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

ConditionSmall Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorHansoh BioMedical R&D Company

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Topotecan

    Drug

    Topotecan will be administered per drug label.

Treatment groups

460 Participants
are divided into 2 treatment groups
Group A: HS-20093Experimental treatment 1 intervention
Group B: TopotecanActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Overall survival

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

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

Secondary outcomes

1

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

Confirmed ORR is defined as the sum of the complete response (CR) rate and partial response (PR) rate as per BICR and investigator per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.

Time frame
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.
2

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

Disease control rate is defined as the proportion of participants who have achieved a best overall response of confirmed CR, confirmed PR, or SD (or non-CR/non-PD) per BICR and investigator assessment per RECIST v1.1.

Time frame
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.
3

Duration of Response Assessed by Blinded Independent Central Review and Investigator

Duration of response (DoR) is defined as the time from the date of the first documentation of objective response (complete response \[CR\] or partial response \[PR\]) to the date of the first documentation of progressive disease (PD) or death.

Time frame
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.
4

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

PFS is defined as the time interval from the randomization to disease progression as per BICR and investigator assessment or death due to any cause.

Time frame
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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hansoh BioMedical R&D Company

Lead sponsor

Source ClinicalTrials.gov
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