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RECRUITING
NCT07245446
PHASE2

A Study of Ivonescimab in First-Line ES-SCLC

Sponsor: Akeso

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

180

Start Date

2025-10-29

Completion Date

2028-06

Last Updated

2025-11-24

Healthy Volunteers

No

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.

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