Actively Recruiting
A Phase II Clinical Study of Ivonescimab Combination Therapy as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer (ES-SCLC)
Led by Akeso · Updated on 2025-11-24
180
Participants Needed
3
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating different combinations of the drug Ivonescimab with chemotherapy and other investigational drugs for the initial treatment of adults with extensive-stage small cell lung cancer (ES-SCLC). The study aims to learn about the side effects participants experience and how well these treatments work to shrink tumors. This Phase II trial compares three groups to find out which combination is most effective and safe. Participants will be randomly assigned to one of three groups. All groups receive Ivonescimab and chemotherapy with etoposide and carboplatin during an initial treatment phase lasting about 3 months. Group 1 also receives AK117, Group 2 receives Cadonilimab, and Group 3 receives Ivonescimab with chemotherapy only. If the treatment is effective and side effects are manageable, participants continue with a maintenance phase using only the study drugs (without chemotherapy) for up to 2 years. During the study, participants will attend regular clinic visits for check-ups, blood tests, and imaging scans like CT scans to monitor their response to treatment. Researchers will measure how well the tumors respond, the duration and time to response, progression-free survival, overall survival, and the incidence of side effects. Monitoring also includes checking drug concentrations and antibodies. The study participation can last up to 5 years for survival follow-up.
CONDITIONS
Brief 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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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 4 cycles of 3 weeks each
Participants receive intravenous administration of Ivonescimab in combination with either AK117, Cadonilimab, or chemotherapy drugs (Etoposide and Carboplatin) as first-line therapy for extensive-stage small cell lung cancer.
Weekly visits for up to 12 weeks
Duration - Up to approximately 5 years
Participants are monitored for safety, disease progression, and survival after completing treatment.
Periodic visits during follow-up
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
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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