Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
180 participants
INTERVENTIONAL
2025-10-29
2028-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Ivonescimab + AK117 + Chemotherapy
Ivonescimab
Administered intravenously at a specified dose and frequency.
AK117
Administered intravenously at a specified dose and frequency.
Etoposide
Administered intravenously at 100 mg/m² on Days 1-3 of each 3-week cycle for 4 cycles.
Carboplatin (AUC 5)
Administered intravenously at AUC 5 on Day 1 of each 3-week cycle for 4 cycles.
Ivonescimab + Cadonilimab + Chemotherapy
Ivonescimab
Administered intravenously at a specified dose and frequency.
Cadonilimab
Administered intravenously at a specified dose and frequency.
Etoposide
Administered intravenously at 100 mg/m² on Days 1-3 of each 3-week cycle for 4 cycles.
Carboplatin (AUC 5)
Administered intravenously at AUC 5 on Day 1 of each 3-week cycle for 4 cycles.
Ivonescimab + Chemotherapy
Ivonescimab
Administered intravenously at a specified dose and frequency.
Etoposide
Administered intravenously at 100 mg/m² on Days 1-3 of each 3-week cycle for 4 cycles.
Carboplatin (AUC 5)
Administered intravenously at AUC 5 on Day 1 of each 3-week cycle for 4 cycles.
Interventions
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Ivonescimab
Administered intravenously at a specified dose and frequency.
Cadonilimab
Administered intravenously at a specified dose and frequency.
AK117
Administered intravenously at a specified dose and frequency.
Etoposide
Administered intravenously at 100 mg/m² on Days 1-3 of each 3-week cycle for 4 cycles.
Carboplatin (AUC 5)
Administered intravenously at AUC 5 on Day 1 of each 3-week cycle for 4 cycles.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Akeso
INDUSTRY
Responsible Party
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Locations
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Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Shanghai Pulmonary Hospital Affiliated to Tongji University
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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AK112-214
Identifier Type: -
Identifier Source: org_study_id
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