Mechanism of Enhanced Efficacy of Ivonescimab in Neoadjuvant Therapy for Non-Small Cell Lung Cancer

Peking University

Status: Not yet enrolling

Conditions: Immunotherapy; Neoadjuvant Therapy; PD-1 Inhibitors; Non-Small Cell Lung Cancer

Treatments: Drug: Ivonescimab; Drug: PD-1 Inhibitors

Study type: Observational

Funder types: Other

Identifiers

NCT07359040

BRWEP2024W034080205

Details and patient eligibility

About

This study primarily aims to compare the efficacy and safety of Ivonescimab (a PD-1/VEGF bispecific antibody) with conventional PD-1 inhibitors in the neoadjuvant treatment of non-small cell lung cancer, as well as to explore the potential mechanisms underlying its enhanced therapeutic effects, thereby providing experimental data to support the clinical application of Ivonescimab.

Full description

Lung cancer is one of the leading causes of cancer-related deaths in China and worldwide, imposing a significant societal burden. Although comprehensive treatment strategies centered around surgery have improved patient prognosis, and perioperative immunotherapy has profoundly reshaped the therapeutic landscape, this field still faces substantial knowledge gaps and key challenges.

This study focuses on Ivonescimab, a first-in-class PD-1/VEGF bispecific antibody. Ivonescimab simultaneously blocks PD-1 to reactivate antitumor immune response by releasing T-cell inhibition and inhibits VEGF to suppress tumor angiogenesis while modulating the immunosuppressive tumor microenvironment. The primary objectives of this research are to evaluate the efficacy and safety of Ivonescimab compared with conventional immunotherapy and to investigate its potential mechanisms of action, thereby providing scientific evidence to support its clinical application.

Enrollment: 80 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients with non-small cell lung cancer (Stage IB-IIIB) who require radical surgery following neoadjuvant therapy.

Exclusion criteria

1. Histology of other malignant tumors, including concurrent malignant tumors of other organ systems;
2. Unresectable advanced disease (Stage IV) or locally advanced unresectable (Stage IIIC);
3. Pregnancy or lactation;
4. Insufficient sample quality;
5. Severe organ dysfunction (e.g. cardiac or renal insufficiency);
6. Other judgments by the Investigator that the patient should not participate in the study.

Trial design

80 participants in 2 patient groups

Ivonescimab neoadjuvant therapy group

Description:

Patients in this group will receive ivonescimab as neoadjuvant therapy

Treatment:

Drug: Ivonescimab

PD-1 inhibitors neoadjuvant therapy group

Description:

Patients in this group will receive other PD-1 inhibitors as neoadjuvant therapy

Treatment:

Drug: PD-1 Inhibitors