NCT03807102

Trial of Tumor Vaccine Used for Adjuvant Therapy in Post Radical Operation Patients With Lung Cancer

Phase I/II Trial of Tumor Vaccine in Post Radical Operation Patients With Lung Cancer

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Yongchang Zhang · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Tumor vaccines may make the body build an immune response to kill tumor cells. This research study is evaluating a new type of tumor vaccine termed as "Neoantigen Tumor Vaccine". The purpose of this phase I/II trial study is to assess the safety and effectiveness of neoantigentumor vaccine in post radical operation patients with stage IIIA lung cancer.

Detailed description

Outline: After successful vaccine manufacturing, patients receive neoantigen tumor vaccine hypodermically (5 injections for each 3 days and then 1 injection for each 3 months till recurrence or up to 2 years). Treatment continues in the absence of disease recurrence and metastasis or unacceptable toxicity. Patients are followed for 2 years or up to the absence of disease recurrence and metastasis. Projected accrual: A total of 30 patients will be accrued for this study.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Tumor Vaccine	NeoAntigen Tumor Vaccine (5 injections for each 3 days and then 1 injection for each 3 months till recurrence or up to 2 years).

Timeline

• Start date: 2024-01-16
• Primary completion: 2025-01-31
• Completion: 2026-01-31
• First posted: 2019-01-16
• Last updated: 2023-12-29

Locations

1 site across 1 country: China