Efficacy and Safety of Immunotherapy in Non-small Cell Lung Cancer With Uncommon Histological Type (Esporta)

January 22, 2022 updated by: Yongchang Zhang, Hunan Province Tumor Hospital

Evaluation of the Efficacy of Immunotherapy in Uncommon Pathological Types of Lung Cancer

This study was designed to explore the efficacy and safety of immune checkpoint inhibitor for advanced uncommon pathological types of lung cancer whether or not it is accompanied by a driver mutationin the real world. Through retrospective collection of clinical data of patients with uncommon pathological types of lung cancer.The patients who are treated with immunosuppressive agents are screened out, and they are divided into immune combination therapy or immune monotherapy, and further evaluate whether there is a difference in efficacy between the two.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a research project involving patients in Medical Oncology Department of Affiliated Cancer Hospital of Xiangya School of Medicine Central South University. Retrospective study of 40 patients with advanced uncommon pathological types of lung cancer and observe the efficacy and safety of immune checkpoint inhibitor regimen in the real world. The patients who are treated with immunosuppressive agents are screened out, and they are divided into immune combination therapy or immune monotherapy, and further evaluate whether there is a difference in efficacy between the two. Statistical analysis is used to compare the differences between the two treatments, so that patients can better choose treatment strategies.

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410013
        • Hunan Cancer Hospital

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Advanced uncommon pathological types of lung cancer by histopathology

Description

Inclusion Criteria:

  • 18，Advanced uncommon pathological types of lung cancer by histopathology whether or not it is accompanied by a driver mutation Treatment Plan is pembrolizumab 200mg iv q21d

Exclusion Criteria:

- Patients received antitumor treatment before Patients with contraindication of chemotherapy Pregnant or breast feeding women

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: may 2019- may 2021
progression survival time
may 2019- may 2021

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OS
Time Frame: may 2019- may 2021
over survival time
may 2019- may 2021

Collaborators and Investigators

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

Sponsor

Hunan Province Tumor Hospital

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 (Actual)

March 2, 2018

Primary Completion (Actual)

August 2, 2021

Study Completion (Actual)

August 3, 2021

Study Registration Dates

First Submitted

August 21, 2021

First Submitted That Met QC Criteria

August 21, 2021

First Posted (Actual)

August 27, 2021

Study Record Updates

Last Update Posted (Actual)

January 25, 2022

Last Update Submitted That Met QC Criteria

January 22, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Esporta

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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