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

Lung Cancer Clinical Trial

— TVATLC01  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03807102
• Other study ID #: TVATLC01
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: January 16, 2024
• Est. completion date: January 31, 2026

Study information

• Verified date: December 2023
• Source: Hunan Province Tumor Hospital
• Contact: Nong Yang, MD
• Phone: +86 731 89762323
• Email: yangnong0217[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: January 31, 2026
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

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).

Locations

Country	Name	City	State
China	Hunan Provincal Tumor Hospital	Changsha	Hunan

Sponsors (2)

Lead Sponsor	Collaborator
Yongchang Zhang	Shanghai Houchao Biotechnology Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

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