Treatment of Non-small Cell Lung Cancer With Cytokine-induced Killer (CIK) Cells Blocked by PD-1 Antibody

September 12, 2017 updated by: Dalian University

Treatment of Non-small Cell Lung Cancer With CIK Cells Blocked by PD-1 Antibody

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • with systematic diseases shortening survival

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CIK cells with PD-1 blocking
CIK cellular therapy with PD-1 blocking combined with standard lung cancer treatment
Biological: CIK cells with PD-1 blocking
CIK cellular therapy with PD-1 blocking
Other: standard lung cancer treament
standard non-small cell lung cancer treatment: surgery, chemotherapy
Active Comparator: CIK cells without PD-1 blocking
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 treament
standard non-small cell lung cancer treatment: surgery, chemotherapy
Biological: CIK cells without PD-1 blocking
CIK cellular therapy without PD-1 blocking

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
progression-free survival
Time Frame: 5 years
5 years
metastasis-free survival
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dalian University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2018

Primary Completion (Anticipated)

January 1, 2023

Study Completion (Anticipated)

January 1, 2023

Study Registration Dates

First Submitted

September 12, 2017

First Submitted That Met QC Criteria

September 12, 2017

First Posted (Actual)

September 14, 2017

Study Record Updates

Last Update Posted (Actual)

September 14, 2017

Last Update Submitted That Met QC Criteria

September 12, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • zsyy_zxsys2018-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

age, gender, tumor staging

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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