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A Study of Ivonescimab in First-Line ES-SCLC

NCT07245446 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2025-11-24

No results posted yet for this study

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.

Conditions

  • Extensive-stage Small Cell Lung Cancer (ES-SCLC)

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.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-29
Primary Completion
2027-12-31
Completion
2028-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07245446 on ClinicalTrials.gov