Clinical Study of Neoantigen Vaccine Combined With Targeted Drugs in the Treatment of Non-small Cell Lung Cancer

NCT04487093 | Unknown Phase 1 DMC

• 1 other identifier: DYYY-2020-04-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Neoantigen vaccine is a new field of research in tumor immunotherapy, and some studies have been conducted with success on Melanoma and glioblastoma. Nearly 80% of lung cancers are diagnosed in an advanced stage (IIIB, and IV) and EGFR mutant non-small cell lung cancer will be resistant after targeted drug treatment. Neoantigen vaccine is a new treatment method for lung cancer, especially for patients with drug resistance.

Conditions

Non Small Cell Lung Cancer

Keywords

non-small cell lung cancer; Individualized neoantigen peptides vaccine; Targeted Drugs; clinical trial; phase I

Outcome Measures

Primary Outcomes (1)

• Adverse events evaluated and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03.

  Safety

  24 months

Secondary Outcomes (3)

• Progression-free Survival (PFS)

  Up to 2 years

• Overall survival (OS)

  Up to 2 years

• Disease Control Rate(DCR)

  Up to 12 weeks

Study Arms (2)

neoantigen vaccine + EGFR-TKI

EXPERIMENTAL

Drug: neoantigen vaccine + EGFR-TKI

neoantigen vaccine + anti-angioge

EXPERIMENTAL

Drug: neoantigen vaccine + anti-angioge

Interventions

neoantigen vaccine + EGFR-TKI DRUG

Patients received subcutaneous injection of individualized neoantigen peptides vaccine at a dose of 200ug per peptide once a week for 5 weeks. The targeted drugs are used continuously according to the instructions and dosage until disease progression or intolerance.

neoantigen vaccine + EGFR-TKI

neoantigen vaccine + anti-angioge DRUG

neoantigen vaccine + anti-angioge

neoantigen vaccine + anti-angioge

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed locally advanced or metastatic non-small-cell lung cancer (stage III or stage IV).
• With EGFR-TKI sensitive mutations and no T790M.
• First generation EGFR-TKI treatment is in progress, the treatment time is 5-6 months and there is no disease progression.
• Patients aged 18 to 85
• Life expectancy of at least 3 months.
• ECOG Performance Status 0 to 3.
• No previous immunotherapy, including anti-PD-1/PD-L1 or co-suppressive T cell receptor drug therapy, peptide / mRNA neoantigen immunotherapy and cell therapy.
• Ability to follow research and follow-up procedures. Able to understand and willing to sign an IRB approved written informed consent document.

You may not qualify if:

• Pregnant and/or breastfeeding.
• With active, known or suspected autoimmune diseases or other concurrent immune system diseases.
• Receive systemic cytotoxic chemotherapy or experimental drugs within 4 weeks before the start of neoantigen treatment, excluding EGFR-TKI and anti-angiogenesis targeted drugs.
• Patients participated in other anticancer drug clinical trials within 4 weeks.
• Liver and kidney dysfunction, severe heart disease, coagulation dysfunction, and impaired hematopoietic function.
• Systemic infection.
• Any uncertainties that have an impact on the safety or compliance of the patient.
• Any disease, treatment, abnormal laboratory history or medical history that affects the participant's participation in the entire research process, or the investigator believes that it is not suitable to participate in this study.

Sponsors & Collaborators

• First Hospital of Shijiazhuang City: lead
• Tianjin Hengjia Biotechnology Development co., LTD: collaborator

Study Sites (1)

The First Hospital of Shijiazhuang

Shijiazhuang, Hebei, 050000, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Yan Zhang, M.D.

  The First Hospital of Shijiazhuang

  STUDY CHAIR

Central Study Contacts

Yan Zhang, M.D.

CONTACT

17603119607; 13315978836@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Oncology IV

Model Details: Patients enrolled without disease progression were given neoantigen vaccine combined with EGFR-TKI therapy； Patients with disease progression were given neoantigen vaccine combined with anti-angiogenesis drug therapy. Patients received subcutaneous injection of individualized neoantigen vaccines at a dose of 200ug per peptide once a week for 5 weeks. The targeted drugs are used continuously according to the instructions and dosage until disease progression or intolerance.

Study Record Dates

• First Submitted: July 23, 2020
• First Posted: July 27, 2020
• Study Start: May 17, 2020
• Primary Completion: May 17, 2022
• Study Completion: December 1, 2022
• Last Updated: July 27, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)