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

NCT03807102 | Unknown Phase 1

• 1 other identifier: TVATLC01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Keywords

Lung Cancer

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Tumor Vaccine

EXPERIMENTAL

Injection of NeoAntigen Tumor Vaccine

Biological: Tumor Vaccine

Interventions

Tumor Vaccine BIOLOGICAL

NeoAntigen Tumor Vaccine (5 injections for each 3 days and then 1 injection for each 3 months till recurrence or up to 2 years).

Tumor Vaccine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yongchang Zhang: lead
• Shanghai Houchao Biotechnology Co., Ltd: collaborator

Study Sites (1)

Hunan Provincal Tumor Hospital

Changsha, Hunan, 410013, China

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Cancer Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Vaccines; Biological Products; Complex Mixtures

Study Officials

• Wenxiang Wang, MD, PhD

  Hunan Provincal Tumor Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nong Yang, MD

CONTACT

+86 731 89762323; yangnong0217@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, pHD, Director of Thoracic Surgery Department II

Study Record Dates

• First Submitted: January 4, 2019
• First Posted: January 16, 2019
• Study Start: January 16, 2024
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2026
• Last Updated: December 29, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)