Trial of Tumor Vaccine Used for Adjuvant Therapy in Post Radical Operation Patients With Lung Cancer (TVATLC01)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lung Cancer
• Intervention / Treatment: Biological: Tumor Vaccine

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Nong Yang, MD; Phone Number: +86 731 89762323; Email: yangnong0217@163.com

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410013
      • Hunan Provincal Tumor Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age: 18 to 70 years, Male or Female
• Histological or cytologically diagnosis of lung adenocarcinoma
• After surgical treatment (lobectomy and systematic lymph node dissection)
• Pathological stage IIIA (According to the IASLC Lung Cancer Staging (eight Edition))
• Postoperative standard treatment (platinum-based double-drug adjuvant treatment with or without chemotherapy) or no adjuvant treatment
• Have potential dynamic tumor biomarkers
• Able and willing to give witnessed, written informed consent form prior to receiving any study related procedure, agree to participate in long-term follow-up for up to 3 years

Exclusion Criteria:

• Age < 18 or< 70 years
• Lung squamous cell carcinoma, small cell lung cancer, large cell lung cancer
• Without surgical treatment
• Pathological stage I、II、IIIB、IIIC or IV (According to the IASLC Lung Cancer Staging (eight Edition))
• Participation in any other clinical trial involving another investigational agent within 4 weeks prior to first dose of study vaccine
• Drug or alcohol abusers
• Pregnant or breast-feeding patients
• History of immunodeficiency disease or autoimmune disease
• Patients with chronic disease which is undergoing immune reagents or hormone therapy
• Concurrent other medical condition that would prevent the patient from undergoing protocol-based therapy
• Lack of availability of a patient for immunological and clinical follow-up

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tumor Vaccine; Injection of NeoAntigen Tumor Vaccine	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-free Survival (DFS)	The time that participants stay free of cancer after surgery following administration of tumor vaccine	Approximately 2 years
Adverse Events (AEs)	Number of participants experiencing clinical and laboratory adverse events	30 days from first study vaccine administration

Collaborators and Investigators

• Sponsor: Yongchang Zhang
• Collaborators: Shanghai Houchao Biotechnology Co., Ltd
• Investigators: Principal Investigator: Wenxiang Wang, MD, PhD, Hunan Provincal Tumor Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 16, 2024
• Primary Completion (Estimated): January 31, 2025
• Study Completion (Estimated): January 31, 2026

Study Registration Dates

• First Submitted: January 4, 2019
• First Submitted That Met QC Criteria: January 12, 2019
• First Posted (Actual): January 16, 2019

Study Record Updates

• Last Update Posted (Actual): December 29, 2023
• Last Update Submitted That Met QC Criteria: December 25, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Lung Cancer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: TVATLC01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No