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

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

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.

Study Overview

• Status: Unknown
• Conditions: Non Small Cell Lung Cancer
• Intervention / Treatment: Drug: neoantigen vaccine + EGFR-TKI; Drug: neoantigen vaccine + anti-angioge

Detailed Description

This is a phase I clinical study of individualized neoantigen peptide vaccine combined with targeted drugs in the treatment of EGFR mutant non-small cell lung cancer aimed to evaluated the safety and immune response of the neoantigen vaccine treatment.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Hebei
    • Shijiazhuang, Hebei, China, 050000
      • Recruiting
      • The First Hospital of Shijiazhuang
      • Contact: Yan Zhang, M.D.; Phone Number: +86 17603119607; Email: 13315978836@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Pregnant and/or breastfeeding.
2. With active, known or suspected autoimmune diseases or other concurrent immune system diseases.
3. Receive systemic cytotoxic chemotherapy or experimental drugs within 4 weeks before the start of neoantigen treatment, excluding EGFR-TKI and anti-angiogenesis targeted drugs.
4. Patients participated in other anticancer drug clinical trials within 4 weeks.
5. Liver and kidney dysfunction, severe heart disease, coagulation dysfunction, and impaired hematopoietic function.
6. Systemic infection.
7. Any uncertainties that have an impact on the safety or compliance of the patient.
8. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: neoantigen vaccine + EGFR-TKI	Drug: neoantigen vaccine + EGFR-TKI; 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.
Experimental: neoantigen vaccine + anti-angioge	Drug: neoantigen vaccine + anti-angioge; neoantigen vaccine + anti-angioge

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events evaluated and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03.	Safety	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival (PFS)	PFS as measured in accordance with the Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1	Up to 2 years
Overall survival (OS)	OS as measured in accordance with the Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1	Up to 2 years
Disease Control Rate(DCR)	DCR as measured in accordance with the Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1	Up to 12 weeks

Collaborators and Investigators

• Sponsor: First Hospital of Shijiazhuang City
• Collaborators: Tianjin Hengjia Biotechnology Development co., LTD
• Investigators: Study Chair: Yan Zhang, M.D., The First Hospital of Shijiazhuang

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2020
• Primary Completion (Anticipated): May 17, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: July 23, 2020
• First Submitted That Met QC Criteria: July 24, 2020
• First Posted (Actual): July 27, 2020

Study Record Updates

• Last Update Posted (Actual): July 27, 2020
• Last Update Submitted That Met QC Criteria: July 24, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: non-small cell lung cancer; clinical trial; phase I; Individualized neoantigen peptides vaccine; Targeted Drugs
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: DYYY-2020-04-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No