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

Sponsor
Peking University People's Hospital
Study ID
NCT07359040
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ivonescimab — DRUG
    Patients in the experimental group will receive ivonescimab as neoadjuvant therapy.
  • PD-1 Inhibitors — DRUG
    Patients in the positive control group will receive PD-1 inhibitors monotherapy as neoadjuvant treatment.

Study Details

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.

Key Dates

Start date
Jul 1, 2025
Status verified
Jun 2026
Primary completion
Dec 21, 2026
Completion
Oct 30, 2027

Study Design

Enrollment
80 participants (estimated)

Arms

  • Arm: Ivonescimab neoadjuvant therapy group
    Patients in this group will receive ivonescimab as neoadjuvant therapy
  • Arm: PD-1 inhibitors neoadjuvant therapy group
    Patients in this group will receive other PD-1 inhibitors as neoadjuvant therapy

Primary Outcome Measure

Pathological Complete Response (pCR [ Time Frame: At surgery (typically 3-6 months post-treatment initiation) ]

Central Contacts

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