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

Non Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04487093
• Other study ID #: DYYY-2020-04-01
• Status: Recruiting
• Phase: Phase 1
• Start date: May 17, 2020
• Est. completion date: December 1, 2022

Study information

• Verified date: May 2020
• Source: First Hospital of Shijiazhuang City
• Contact: Yan Zhang, M.D.
• Phone: 17603119607
• Email: 13315978836[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 1, 2022
• Est. primary completion date: May 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

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.
• neoantigen vaccine + anti-angioge
neoantigen vaccine + anti-angioge

Locations

Country	Name	City	State
China	The First Hospital of Shijiazhuang	Shijiazhuang	Hebei

Sponsors (2)

Lead Sponsor	Collaborator
First Hospital of Shijiazhuang City	Tianjin Hengjia Biotechnology Development co., LTD

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events evaluated and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03.	Safety	24 months
Secondary	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
Secondary	Overall survival (OS)	OS as measured in accordance with the Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1	Up to 2 years
Secondary	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