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Trial Title:
A Study of HS-20093 vs Active Surveillance in Limited-Stage Small Cell Lung Cancer
NCT ID:
NCT06526624
Condition:
Limited-stage Small-cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
HS-20093
Description:
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.
Arm group label:
HS-20093
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.
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 with limited-stage small cell lung cancer (LS-SCLC) who have not
progressed after receiving chemoradiotherapy (CRT).
This study consists of an experimental arm and a control arm. The experimental arm will
be administered HS-20093, and the control arm will only receive active surveillance.
Efficacy and safety were assessed in both arms by follow-up analyses.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Have signed Informed Consent Form.
2. Males or females ≥18 years old.
3. Patients with limited-stage SCLC who are deemed unsuitable for surgery or decline
surgery.
4. ECOG performance status of 0-1.
5. Patients who have received CRT and have not progressed.
6. Minimum life expectancy > 12 weeks.
7. Males or Females should be using adequate contraceptive measures throughout the
study.
8. Females must not be pregnant at screening or have evidence of non-childbearing
potential.
Exclusion Criteria:
1. Patients with mixed SCLC or NSCLC or sarcoma-like carcinoma, or large cell
neuroendocrine carcinoma.
2. Patients with extensive-stage SCLC.
3. Disease progression during CRT or before randomization.
4. Received or are receiving the following treatments:
1. For LS-SCLC, prior treatment with or current use of other chemotherapy regimens
other than platinum plus etoposide
2. Received any other anti-cancer treatment.
3. Previous or current treatment with B7-H3 target therapy.
4. Traditional Chinese medicine indicated for tumors within 2 weeks prior to the
first dose of study drug.
5. Major surgery within 4 weeks prior to the first dose of study drug.
5. Interstitial lung disease (ILD)/non-infectious pneumonitis.
6. History of other primary malignancies.
7. Inadequate bone marrow reserve or organ functions.
8. Severe, uncontrolled or active cardiovascular disorders.
9. Severe or uncontrolled diabetes.
10. Serious or poorly controlled hypertension.
11. Severe bleeding symptoms or bleeding tendencies within 1 month prior to
randomization.
12. Severe arteriovenous thrombosis occurred within 3 months prior to randomization.
13. Serious infection within 4 weeks prior to randomization.
14. Presence of Grade ≥ 2 toxicities due to prior anti-tumor therapy.
15. Having serious neurological or mental disorders.
16. History of hypersensitivity to any component of HS-200093 or its similar drugs.
17. Participants with any condition that compromises the safety of the participant or
interferes with the assessment of the study, as judged by the investigator.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
September 30, 2024
Completion date:
January 31, 2029
Lead sponsor:
Agency:
Hansoh BioMedical R&D Company
Agency class:
Industry
Source:
Hansoh BioMedical R&D Company
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06526624
