NCT06526624Not yet recruitingPhase 3
A Study of HS-20093 vs Active Surveillance in Limited-Stage Small Cell Lung Cancer
ARTEMIS-009: A Phase 3, Randomized, Controlled, Multi-center, Open-label Study of HS-20093 Versus Active Surveillance As Consolidation Therapy After Chemoradiotherapy in Subjects With Limited-Stage Small Cell Lung Cancer
Source: ClinicalTrials.gov · Last updated 30 Jul 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 406 (estimated)
- First submitted
- 25 Jul 2024
- Start date
- 30 Sept 2024
- Primary completion date
- 30 Nov 2027
- Lead sponsor
- Hansoh BioMedical R&D Company
- Diseases
- Lung cancer
- NCT number
- NCT06526624
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 406
- From 30 Sept 2024 to the primary completion date, 30 Nov 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- 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.
Other illness
- Disease progression during CRT or before randomization.
- Interstitial lung disease (ILD)/non-infectious pneumonitis.
- History of other primary malignancies.
- Severe, uncontrolled or active cardiovascular disorders.
- Severe or uncontrolled diabetes.
- Serious or poorly controlled hypertension.
- 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.
Other
- Patients with mixed SCLC or NSCLC or sarcoma-like carcinoma, or large cell neuroendocrine carcinoma.
- Patients with extensive-stage SCLC.
- Inadequate bone marrow reserve or organ functions.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.