Clinical trial NCT03807102: Trial of Tumor Vaccine Used for Adjuvant Therapy in Post Radical Operation Patients With Lung Cancer
Official title: Phase I/II Trial of Tumor Vaccine in Post Radical Operation Patients With Lung Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Lung Cancer
Keywords: Lung Cancer
Lead sponsor: Hunan Province Tumor Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Houchao Biotechnology Co., Ltd
First posted: 2019-01-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Disease-free Survival (DFS)
timeFrame: Approximately 2 years
measure: Adverse Events (AEs)
timeFrame: 30 days from first study vaccine administration
Secondary outcomes:
Other outcomes:
Locations:
city: Changsha
country: China
facility: Hunan Provincal Tumor Hospital
state: Hunan
Study officials:
affiliation: Hunan Provincal Tumor Hospital
name: Wenxiang Wang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: