Mechanism of Enhanced Efficacy of Ivonescimab in Neoadjuvant Therapy for Non-Small Cell Lung Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorPeking University People's Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
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;
Trial population
The study primarily involves patients with small cell lung cancer who require neoadjuvant immunotherapy.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Ivonescimab
DrugPatients in the experimental group will receive ivonescimab as neoadjuvant therapy.
PD-1 Inhibitors
DrugPatients in the positive control group will receive PD-1 inhibitors monotherapy as neoadjuvant treatment.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Ivonescimab neoadjuvant therapy group1 intervention
Group B: PD-1 inhibitors neoadjuvant therapy group1 intervention
Trial outcomes
Primary outcomes
1
Pathological Complete Response (pCR
Pathologic Complete Response (pCR) is defined as the absence of residual tumor in both the primary lung tumor site and all sampled regional lymph nodes after neoadjuvant immunotherapy, confirmed through systematic pathological examination of the surgical specimen.
Time frame
At surgery (typically 3-6 months post-treatment initiation)Secondary outcomes
1
Major Pathological Response (MPR)
Major Pathologic Response (MPR) is defined as the presence of ≤10% residual viable tumor cells in both the primary lung tumor site and sampled regional lymph nodes after neoadjuvant immunotherapy, confirmed through systematic pathological examination of the surgical specimen.
Time frame
At surgery (typically 3-6 months post-treatment initiation)2
Objective Response Rate (ORR)
ORR is defined as the proportion of patients achieving either a complete response (CR; disappearance of all target lesions) or partial response (PR; ≥30% reduction in the sum of target lesion diameters) during or after neoadjuvant immunotherapy, as assessed by serial imaging (CT/PET-CT) using iRECIST criteria.
Time frame
After two cycles or four cycles of neoadjuvant therapy (each cycle is 21 days).3
Event-free Survival (EFS)
Time from randomization to the occurrence of any of the following events: disease progression, recurrence, discontinuation of treatment due to toxicity, initiation of new anticancer therapy, or death from any cause.
Time frame
Through study completion, an average of 2 years.4
Overall Survival (OS)
Time from randomization to death from any cause.
Time frame
Through study completion, an average of 2 years.Sponsors and contacts
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Source ClinicalTrials.gov