Actively Recruiting
Phase II Study of Ivonescimab and Cadonilimab in Combination with Chemotherapy in Patients with ES-SCLC
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
This is a phase II study. All patients are treatment naive extensive stage small cell lung cancer(ES-SCLC), Eastern Cooperative Oncology Group (ECOG) performance status 0-1. The purpose of this study is to evaluate the efficacy and safety of Ivonescimab and Cadonilimab in combination with chemotherapy in patients with ES-SCLC.
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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Actively Recruiting
Research Team
G
Ge Gao, PhD
CONTACT
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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