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

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.

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.

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