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A Study of HS-20093 vs Active Surveillance in Limited-Stage Small Cell Lung Cancer

ConditionLimited-stage Small-cell Lung Cancer
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorHansoh BioMedical R&D Company

About this trial

This study will evaluate the efficacy, safety and tolerability of HS-20093 compared with active surveillance as consolidation therapy after chemoradiotherapy in participants with limited-stage small cell lung cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Have signed Informed Consent Form.

Males or females ≥18 years old.

Patients with limited-stage SCLC who are deemed unsuitable for surgery or decline surgery.

ECOG performance status of 0-1.

Disqualifiers

Patients with mixed SCLC or NSCLC or sarcoma-like carcinoma, or large cell neuroendocrine carcinoma.

Patients with extensive-stage SCLC.

Disease progression during CRT or before randomization.

For LS-SCLC, prior treatment with or current use of other chemotherapy regimens other than platinum plus etoposide

Trial design

Design model

Parallel

Treatments tested in this trial

  • HS-20093

    Drug

    Subjects in experimental arm will be given HS-20093 intravenously at a dose of 8.0 mg/kg every 3 weeks, until disease progression or until other criteria for treatment discontinuation are met.

Treatment groups

406 Participants
are divided into 2 treatment groups
Group A: HS-20093Experimental treatment 1 intervention
Group B: Active surveillanceNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Progression-free survival (PFS) According to RECIST v1.1 by Independent Review Committee (IRC)

To assess the efficacy of HS-20093 vs active surveillance in terms of PFS. PFS is defined as the time from randomization until the date of objective disease progression or death, whichever occurred first, based on IRC using RECIST v1.1.

Time frame
Approximately 6 years
2

Overall survival (OS)

To assess the efficacy of HS-20093 vs active surveillance in terms of OS. Overall Survival is defined as the time from the date of randomization to the date of participant's death due to any cause.

Time frame
Approximately 6 years

Secondary outcomes

1

PFS at 12 Months (PFS12) or 18 Months (PFS18) According to RECIST v1.1 by IRC

PFS12 and PFS18 are defined as the progression-free survival at 12 months and 18 months from the date of randomization, respectively, based on IRC using RECIST v1.1.

Time frame
Approximately 6 years.
2

ORR According to RECIST v1.1 by IRC

ORR is defined as the percentage of participants with BOR of CR or PR per RECIST v1.1

Time frame
From the date of randomization until the date of disease progression or withdrawal from study, up to approximately 6 years.
3

DCR According to RECIST v1.1 by IRC

DCR is defined as the percentage of patients who have a best overall response (confirmed CR, PR, or stable disease)

Time frame
From the date of randomization until the date of disease progression or withdrawal from study, approximately 6 years.
4

DoR by IRC

DoR only applies to participants whose best overall response is CR or PR. The start date is the date of first documented response of CR or PR, and the end date is defined as the date of the first documented progression or death due to underlying disease.

Time frame
From the date of CR, PR until the date of disease progression or death, approximately 6 years.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Hansoh BioMedical R&D Company

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: