NCT03282435

Brief Summary

to evaluate the prognosis of non-small cell lung carcinoma patients under CIK cellular treatment with PD-1 blocking on top of the standard therapy

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1 nonsmall-cell-lung-cancer

Timeline
Completed

Started Jan 2018

Typical duration for phase_1 nonsmall-cell-lung-cancer

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

September 12, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

September 14, 2017

Status Verified

September 1, 2017

Enrollment Period

5 years

First QC Date

September 12, 2017

Last Update Submit

September 12, 2017

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

  • progression-free survival

    5 years

  • metastasis-free survival

    5 years

Study Arms (2)

CIK cells with PD-1 blocking

EXPERIMENTAL

CIK cellular therapy with PD-1 blocking combined with standard lung cancer treatment

Biological: CIK cells with PD-1 blockingOther: standard lung cancer treament

CIK cells without PD-1 blocking

ACTIVE COMPARATOR

CIK cellular therapy without PD-1 blocking combined with the same standard lung cancer treatment as the experimental group patients receive

Other: standard lung cancer treamentBiological: CIK cells without PD-1 blocking

Interventions

CIK cells with PD-1 blockingBIOLOGICAL

CIK cellular therapy with PD-1 blocking

CIK cells with PD-1 blocking
standard lung cancer treamentOTHER

standard non-small cell lung cancer treatment: surgery, chemotherapy

CIK cells with PD-1 blockingCIK cells without PD-1 blocking
CIK cells without PD-1 blockingBIOLOGICAL

CIK cellular therapy without PD-1 blocking

CIK cells without PD-1 blocking

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • non-small cell lung cancer;
  • more than 50% tumor tissues positive with PD-L1;
  • EGFR and ALK wild type
  • no other tumors

You may not qualify if:

  • with systematic diseases shortening survival

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

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

Study Officials

  • xiaolin Yuan

    Affiliated Zhongshan Hospital of Dalian University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

haoren wang

CONTACT

86-041162893507haoren_wang@yahoo.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2017

First Posted

September 14, 2017

Study Start

January 1, 2018

Primary Completion

January 1, 2023

Study Completion

January 1, 2023

Last Updated

September 14, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will share

age, gender, tumor staging