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Immunosensitized Radiotherapy Combined With Evoximab (AK112) and Chemotherapy Neoadjuvant Therapy for Stage II-III Non-small Cell Lung Cancer

NCT06391008 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2024-04-30

No results posted yet for this study

Summary

This is an open label, prospective, single center Phase II clinical study. Intended to evaluate the main pathological response rate (MPR) and safety of stereotactic immunosensitized radiotherapy combined with Evoximab (PD-1/VEGF-A bispecific antibody) and chemotherapy neoadjuvant therapy for stage II-III NSCLC. Simultaneously observe and evaluate the complete pathological response rate (pCR), R0 resection rate, and event free survival (EFS) of stage II-III NSCLC treated with stereotactic radiotherapy combined with Evoximab (PD-1/VEGF-A bispecific antibody) and chemotherapy. Exploratory analysis based on serum/tumor molecular biological markers, as well as the optimal response time and mechanism for combined response.

Conditions

  • Stereotactic Radiotherapy; Evoximab (AK112); New Adjuvant Therapy for Non-small Cell Lung Cancer

Interventions

RADIATION

Stereotactic radiotherapy

Targeting primary lung lesions and irradiable mediastinal lymph nodes, stereotactic large segment radiotherapy was performed to complete the prescribed dose, PTV (planned target area): 5Gy x 3f

DRUG

Evoximab

Evoximab (20mg/kg, Q3W)

DRUG

Pemetrexed

Pemetrexed (500mg/m2, Q3W)

DRUG

Albumin Paclitaxel

Albumin Paclitaxel 260 mg/m2, Q3W

DRUG

Carboplatin

Carboplatin (AUC5, Q3W)

Sponsors & Collaborators

  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-30
Primary Completion
2024-12-30
Completion
2025-06-30

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Entities

Drugs

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 NCT06391008 on ClinicalTrials.gov