NCT02956551

Brief Summary

The study is aimed to the test the efficacy and safety of neoantigen-primed dendritic cell (DC) cell vaccine therapy for refractory non-small cell lung cancer.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2016

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 7, 2016

Completed
23 days until next milestone

Study Start

First participant enrolled

November 30, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

May 31, 2018

Status Verified

May 1, 2018

Enrollment Period

3.1 years

First QC Date

November 1, 2016

Last Update Submit

May 29, 2018

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

advanced non-small cell lung cancercell based therapysafetyclinical efficacy

Outcome Measures

Primary Outcomes (1)

  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    3 months after the last administration of cells

Secondary Outcomes (1)

  • objective response rate

    through study completion, an average of 1 year

Study Arms (1)

cell_therapy

EXPERIMENTAL

tumor neoantigen primed DC vaccines are administrated, 2-week interval, totally 5 times

Biological: DC vaccine

Interventions

DC vaccineBIOLOGICAL

subcutaneous administration

cell_therapy

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • pathologically confirmed non-small cell lung cancer
  • failed in previous standard chemotherapy and targeted therapy
  • anticipated life time \> 3month
  • Karnofsky performance status 0-1
  • rehabilitate from previous therapy
  • adequate organ functions

You may not qualify if:

  • mixed histological types
  • tumor emergency
  • abnormal coagulation condition
  • contagious diseases, such as hepatitis B virus, hepatitis C virus, human immunodefficiency virus, tuberculosis infection
  • concomitant tumors
  • immunological co-morbidities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China West Hospital

Chengdu, Sichuan, 610000, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

lentiviral minigene vaccine of COVID-19 coronavirus

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Zhen-Yu Ding, Prof

    Sichuan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhen-Yu Ding, Prof

CONTACT

dingzhenyu@scu.edu.cn

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 1, 2016

First Posted

November 7, 2016

Study Start

November 30, 2016

Primary Completion

December 31, 2019

Study Completion

June 1, 2020

Last Updated

May 31, 2018

Record last verified: 2018-05

Locations

CN(1)