Actively Recruiting
A Study of Ivonescimab in First-Line ES-SCLC
Led by Akeso · Updated on 2025-11-24
180
Participants Needed
3
Research Sites
135 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn if different combinations of a drug called Ivonescimab, along with chemotherapy and other investigational drugs, are safe and effective for the initial treatment of adults with extensive-stage small cell lung cancer (ES-SCLC). The main questions the study aims to answer are: * What side effects do participants experience from these combination treatments? * How well do the treatments work to shrink tumors? Researchers will compare three groups to see which combination works best. All participants will receive Ivonescimab and chemotherapy (etoposide and carboplatin). The differences are: * Group 1 will also receive an additional drug called AK117. * Group 2 will also receive a different additional drug called Cadonilimab. * Group 3 will receive Ivonescimab and chemotherapy only. Participants will: * Be assigned by chance to one of the three groups. * Undergo an initial treatment phase (about 3 months), receiving chemotherapy plus the specific study drugs for their group. * If the treatment is effective and side effects are manageable, continue with a maintenance phase using only the study drugs (without chemotherapy) for up to 2 years. * Attend regular clinic visits for check-ups, blood tests, and imaging scans (like CT scans) to see how they are responding to the treatment.
CONDITIONS
Official Title
A Study of Ivonescimab in First-Line ES-SCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC).
- No prior systemic therapy for ES-SCLC.
- At least one measurable lesion as defined by RECIST v1.1.
- Age 18 to 75 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate organ function.
You will not qualify if you...
- Active or untreated central nervous system (CNS) metastases (treated, stable brain metastases are allowed).
- History of severe hypersensitivity to monoclonal antibodies.
- Active autoimmune disease requiring systemic treatment within the past 2 years.
- Significant cardiovascular disease.
- Active hepatitis B or C, or HIV infection.
- Interstitial lung disease or non-infectious pneumonitis.
- Significant bleeding tendency or risk, including tumor invasion of major blood vessels.
- Pregnancy or lactation.
- Other active malignancies within 5 years prior to enrollment.
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100020
Not Yet Recruiting
2
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China, 710000
Actively Recruiting
3
Shanghai Pulmonary Hospital Affiliated to Tongji University
Shanghai, Shanghai Municipality, China, 200433
Actively Recruiting
Research Team
W
Wenting Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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