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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Lung Cancer

Intervention / Treatment
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* Biological: Tumor Vaccine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tumor Vaccine<br>Injection of NeoAntigen Tumor Vaccine | Biological: Tumor Vaccine<br>* NeoAntigen Tumor Vaccine (5 injections for each 3 days and then 1 injection for each 3 months till recurrence or up to 2 years).<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung Cancer