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

Phase 1

• Conditions: Non Small Cell Lung Cancer
• Interventions: Drug: neoantigen vaccine + EGFR-TKI; Drug: neoantigen vaccine + anti-angioge

• Registration Number: NCT04487093
• Lead Sponsor: First Hospital of Shijiazhuang City

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.

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 Timeline

• Status Verified: 2020-05
• Study Start: 2020-05-17
• Study First Submitted: 2020-07-23
• Study First Submitted QC: 2020-07-24
• Last Update Submitted: 2020-07-24
• Study First Posted: 2020-07-27
• Last Update Posted: 2020-07-27
• Primary Completion: 2022-05-17
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
neoantigen vaccine + EGFR-TKI	neoantigen vaccine + EGFR-TKI	-
neoantigen vaccine + anti-angioge	neoantigen vaccine + anti-angioge	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The First Hospital of Shijiazhuang; 🇨🇳 Shijiazhuang, Hebei, China