NCT06391008

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

Immunosensitized Radiotherapy Combined With Evoximab (AK112) and Chemotherapy Neoadjuvant Therapy for Stage II-III Non-small Cell Lung Cancer: a Single Arm, Open Label, Phase II Clinical Study

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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)

Timeline

• Start date: 2024-04-30
• Primary completion: 2024-12-30
• Completion: 2025-06-30
• First posted: 2024-04-30
• Last updated: 2024-04-30