RecruitingPhase 2NCT07245446

A Study of Ivonescimab in First-Line ES-SCLC

A Phase II Clinical Study of Ivonescimab Combination Therapy as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer (ES-SCLC)


Sponsor

Akeso

Enrollment

180 participants

Start Date

Oct 29, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests ivonescimab — a novel drug that combines both immunotherapy (PD-1 blocker) and anti-angiogenic effects (cutting off tumor blood supply) in a single molecule — as a first-line treatment option for extensive-stage small cell lung cancer (SCLC), an aggressive form of lung cancer. **You may be eligible if...** - You have been confirmed to have extensive-stage small cell lung cancer - You have not yet received any systemic treatment for this cancer - You are 18 to 75 years old and in reasonable health - You have at least one measurable tumor on imaging scans **You may NOT be eligible if...** - You have received prior chemotherapy or other systemic treatment for SCLC - You have untreated cancer spread to the brain - You have active autoimmune disease or are on immune-suppressing drugs - You have significant heart or blood vessel problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIvonescimab

Administered intravenously at a specified dose and frequency.

DRUGCadonilimab

Administered intravenously at a specified dose and frequency.

DRUGAK117

Administered intravenously at a specified dose and frequency.

DRUGEtoposide

Administered intravenously at 100 mg/m² on Days 1-3 of each 3-week cycle for 4 cycles.

DRUGCarboplatin (AUC 5)

Administered intravenously at AUC 5 on Day 1 of each 3-week cycle for 4 cycles.


Locations(3)

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

View Full Details on ClinicalTrials.gov

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NCT07245446


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