Status:
NOT_YET_RECRUITING
A Study of HS-20093 vs Active Surveillance in Limited-Stage Small Cell Lung Cancer
Lead Sponsor:
Hansoh BioMedical R&D Company
Conditions:
Limited-stage Small-cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 c...
Detailed Description
This is a randomized, controlled, open-label, multi-center, phase III clinical study to evaluate the efficacy and safety of HS-20093 versus active surveillance as consolidation therapy in participants...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- Severe bleeding symptoms or bleeding tendencies within 1 month prior to randomization.
- Severe arteriovenous thrombosis occurred within 3 months prior to randomization.
- Serious infection within 4 weeks prior to randomization.
- Presence of Grade ≥ 2 toxicities due to prior anti-tumor therapy.
- Having serious neurological or mental disorders.
- History of hypersensitivity to any component of HS-200093 or its similar drugs.
- Participants with any condition that compromises the safety of the participant or interferes with the assessment of the study, as judged by the investigator.
Key Trial Info
Start Date :
September 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2029
Estimated Enrollment :
406 Patients enrolled
Trial Details
Trial ID
NCT06526624
Start Date
September 30 2024
End Date
January 31 2029
Last Update
July 30 2024
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