Clinical Study of Neoantigen Vaccine Combined With Target... | NCT04487093

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

NCT04487093

Sponsor

First Hospital of Shijiazhuang City

Status

Unknown status

Last Update Posted

Jul 27, 2020Actual

Enrollment

20Estimated

Phase

Phase 1

Conditions

Non Small Cell Lung Cancer

Interventions

neoantigen vaccine + EGFR-TKI
neoantigen vaccine + anti-angioge

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 17, 2020Actual

Primary Completion Date

May 17, 2022Estimated

Completion Date

Dec 1, 2022Estimated

First Submitted Date

Jul 23, 2020

First Submission Date that Met QC Criteria

Jul 24, 2020

First Posted Date

Jul 27, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 24, 2020

Last Update Posted Date

Jul 27, 2020Actual

Name	Class
Tianjin Hengjia Biotechnology Development co., LTD	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
neoantigen vaccine + EGFR-TKI	Experimental		Drug: neoantigen vaccine + EGFR-TKI
neoantigen vaccine + anti-angioge	Experimental		Drug: neoantigen vaccine + anti-angioge

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Yan Zhang, M.D.	Contact	17603119607		13315978836@163.com

Name	Affiliation	Role
Yan Zhang, M.D.	The First Hospital of Shijiazhuang	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
The First Hospital of Shijiazhuang	Recruiting	Shijiazhuang	Hebei	050000	China

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms

Intervention Model Description

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.