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

NCT06526624 | Not Yet Recruiting Phase 3 FDA Drug

• 1 other identifier: HS-20093-302
• Study Type: interventional
• Target: 406
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Limited-stage Small-cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• 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.

  Approximately 6 years

• 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.

  Approximately 6 years

Secondary Outcomes (11)

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

  Approximately 6 years.

• ORR According to RECIST v1.1 by IRC

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

• DCR According to RECIST v1.1 by IRC

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

• DoR by IRC

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

• PFS According to RECIST v1.1 by investigators (INVs)

  Approximately 6 years.

Study Arms (2)

HS-20093

EXPERIMENTAL

Patients with LS-SCLC who have not progressed following CRT. Patients in this arm will be administrated HS-20093 intravenously at a dose of 8.0 mg/kg, Q3W continuously until disease progression or until other criteria for discontinuation of treatment are met.

Drug: HS-20093

Active surveillance

NO INTERVENTION

Patients with LS-SCLC who have not progressed following CRT. Patients in this arm will receive active surveillance until disease progression or until other criteria for discontinuation of active surveillance are met.

Interventions

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.

HS-20093

Eligibility Criteria

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

You may qualify if:

• 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.
• Patients who have received CRT and have not progressed.
• Minimum life expectancy \> 12 weeks.
• Males or Females should be using adequate contraceptive measures throughout the study.
• Females must not be pregnant at screening or have evidence of non-childbearing potential.

You may not qualify if:

• 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.
• Received or are receiving the following treatments:
• For LS-SCLC, prior treatment with or current use of other chemotherapy regimens other than platinum plus etoposide
• Received any other anti-cancer treatment.
• Previous or current treatment with B7-H3 target therapy.
• Traditional Chinese medicine indicated for tumors within 2 weeks prior to the first dose of study drug.
• Major surgery within 4 weeks prior to the first dose of study drug.
• Interstitial lung disease (ILD)/non-infectious pneumonitis.
• History of other primary malignancies.
• Inadequate bone marrow reserve or organ functions.
• Severe, uncontrolled or active cardiovascular disorders.
• Severe or uncontrolled diabetes.
• Serious or poorly controlled hypertension.

Sponsors & Collaborators

• Hansoh BioMedical R&D Company: lead

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

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

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 25, 2024
• First Posted: July 30, 2024
• Study Start: September 30, 2024
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): January 31, 2029
• Last Updated: July 30, 2024

Record last verified: 2024-07