Actively Recruiting
Phase II Study of Ivonescimab and Cadonilimab with Etoposide and Carboplatin as First-line Treatment for Extensive Stage Small Cell Lung Cancer
Led by Sichuan University · Updated on 2025-01-10
80
Participants Needed
1
Research Sites
151 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a Phase II study to evaluate the safety and effectiveness of combining Ivonescimab and Cadonilimab with chemotherapy in patients who have extensive stage small cell lung cancer (ES-SCLC) and have not received prior treatment. Participants must have an ECOG performance status of 0-1, indicating they are fully active or restricted in physically strenuous activity but ambulatory. The study aims to assess how well this combination therapy works and how safe it is for these patients. Participants will receive Ivonescimab at a dose of 20 mg/kg by intravenous infusion on Day 1 every 3 weeks, and Cadonilimab at 10 mg/kg by intravenous infusion on Day 8 every 6 weeks. They will also be treated with chemotherapy drugs Etoposide (100 mg/kg IV infusion on Days 1-3 every 3 weeks) and Carboplatin (AUC 5 IV infusion on Day 1 every 3 weeks). This treatment plan is given as first-line therapy to patients with ES-SCLC. During the study, participants will be closely monitored for their response to treatment and safety for up to approximately two years. Researchers will evaluate tumor response using established criteria and will track any side effects or adverse events. Participants will undergo regular assessments including clinical examinations and laboratory tests to ensure safety and to measure treatment effectiveness throughout the study period.
CONDITIONS
Official Title
Phase II Study of Ivonescimab and Cadonilimab in Combination with Chemotherapy in Patients with ES-SCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and voluntarily sign an informed consent form before study procedures
- Aged 18 to 75 years at the time of consent
- Have an ECOG performance status of 0 or 1
- Life expectancy of at least 3 months
- Histologically or cytologically confirmed diagnosis of extensive stage small cell lung cancer
- No previous systemic therapy; or had definitive chemoradiotherapy for limited-stage SCLC with disease progression more than 6 months ago
- Have measurable disease based on RECIST 1.1 criteria
- Able to provide formalin fixed, paraffin-embedded tumor tissue from a biopsy
- Have adequate organ function
- All males and females of reproductive potential must agree to use effective contraception during and for 120 days after the last dose of study treatment
You will not qualify if you...
- Active malignancies within the past 5 years except tumors in this study or cured local tumors
- Received palliative local treatment or non-specific immunomodulatory treatment within 2 weeks before first dose; Chinese herbal medicine with anti-tumor effects within 1 week before first dose
- Prior treatments targeting tumor immunity
- Prior anti-angiogenic therapy
- Tumor involving important blood vessels or organs with necrosis, cavitation, or invasion
- Active autoimmune disease requiring systemic treatment within 2 years before study
- Symptomatic central nervous system metastases
- Clinically symptomatic pleural, pericardial effusion, or ascites needing frequent drainage
- History of gastrointestinal perforation, fistula, obstruction, or extensive bowel resection within 6 months before first dose
- Known active Hepatitis B or C infection
- History of myocardial infarction, unstable angina, cardiac or vascular procedures within 12 months before study
- Severe infection within 4 weeks before first dose or active infection treated within 2 weeks before first dose
- Concurrent enrollment in another clinical study unless noninterventional or follow-up period exceeds 4 weeks or 5 half-lives of prior drug
AI-Screening
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Trial Site Locations
Total: 1 location
1
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Actively Recruiting
Research Team
G
Ge Gao, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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