A Study of Ivonescimab in First-Line ES-SCLC
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ivonescimab, Cadonilimab, AK117, Etoposide.
- Who it may be relevant to
- Registry conditions: Extensive-stage Small Cell Lung Cancer (ES-SCLC). Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Phase II Clinical Study of Ivonescimab Combination Therapy as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer (ES-SCLC)
Overview
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.
Interventions
- Drug Ivonescimab
Administered intravenously at a specified dose and frequency. - Drug Cadonilimab
Administered intravenously at a specified dose and frequency. - Drug AK117
Administered intravenously at a specified dose and frequency. - Drug Etoposide
Administered intravenously at 100 mg/m² on Days 1-3 of each 3-week cycle for 4 cycles. - Drug Carboplatin (AUC 5)
Administered intravenously at AUC 5 on Day 1 of each 3-week cycle for 4 cycles.
Primary outcome measures
- Objective Response Rate (ORR) [Time frame: Up to approximately 2 years.]
- Incidence of Adverse Events (AEs) [Time frame: From first dose up to 90 days after last dose.]
Secondary outcome measures (7)
- Disease Control Rate (DCR) [Time frame: Up to approximately 2 years.]
- Duration of Response (DoR) [Time frame: Up to approximately 2 years.]
- Time to Response (TTR) [Time frame: Up to approximately 2 years.]
- Progression-Free Survival (PFS) [Time frame: Up to approximately 2 years.]
- Overall Survival (OS) [Time frame: Up to approximately 5 years.]
- Serum concentrations of Ivonescimab, Cadonilimab, and AK117 [Time frame: Up to approximately 2 years.]
- Incidence of Anti-drug Antibodies (ADA) [Time frame: Up to approximately 2 years.]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 3 centers
- Cancer Hospital Chinese Academy of Medical Sciences — Beijing
- The First Affiliated Hospital of Xi'an Jiaotong University — Xi'an
- Shanghai Pulmonary Hospital Affiliated to Tongji University — Shanghai
Identifiers
NCT: NCT07245446 · AK112-214