RecruitingNCT07359040

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

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

Sponsor

Peking University People's Hospital

Enrollment

80 participants

Start Date

Jul 1, 2025

Study Type

OBSERVATIONAL

Conditions

Neoadjuvant Therapy Non-small Cell Lung Cancer Immunotherapy PD-1 Inhibitors

Summary

This is an exploratory clinical study focusing on the neoadjuvant treatment of non-small cell lung cancer (NSCLC). The study primarily aims to compare the efficacy and safety of Ivonescimab, a novel PD-1/VEGF bispecific antibody, with those of conventional PD-1 inhibitors. Beyond evaluating its direct therapeutic benefits, this research also seeks to elucidate the potential mechanisms underlying the enhanced efficacy of Ivonescimab. Additionally, the study will conduct secondary exploratory analyses, including the identification and validation of predictive and prognostic biomarkers, as well as multi-omics profiling to investigate the molecular mechanisms of action. Collectively, these efforts aim to provide comprehensive experimental data to support the rational clinical application of Ivonescimab and the development of precision medicine strategies for NSCLC.

Eligibility

Inclusion Criteria1

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

Exclusion Criteria6

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

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Interventions

DRUGIvonescimab

Patients in the experimental group will receive ivonescimab as neoadjuvant therapy.

DRUGPD-1 Inhibitors

Patients in the positive control group will receive PD-1 inhibitors monotherapy as neoadjuvant treatment.

Locations(1)

Peking University People's Hospital

Beijing, Beijing Municipality, China

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NCT07359040

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