Efficacy of Osimertinib in Patients With Lung Cancer

December 8, 2023 updated by: Yongchang Zhang, Hunan Province Tumor Hospital

Efficacy of Osimertinib in Patients With Lung Cancer Positive for Uncommon EGFR Exon 19 Deletion Mutations

This is a descriptive observational study, in which data are collected in an epidemiological fashion and prospective. This study does not intend to intervene the current medical practice of the recruited patients.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China
        • Recruiting
        • Hunan Cancer Hospital
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

advanced or metastatic (stage IV) lung cancer

Description

Inclusion Criteria:

  • Patients must be ≥18 years.
  • Provision of fully informed consent prior to any study specific procedures.
  • Advanced or metastatic lung squamous cell carcinoma confirmed by histology or cytology.
  • According to the RECIST 1.1 standard, the patient must have at least one measurable lesion.

Exclusion Criteria:

  • None

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progression-free survival
Time Frame: 3 years
From registration onto that step until death, or censored at the date of last contact.
3 years
Overall survival
Time Frame: 3 years
From registration onto that step until death, or censored at the date of last contact.
3 years

Collaborators and Investigators

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

Sponsor

Hunan Province Tumor Hospital

Investigators

  • Principal Investigator: Yongchang Zhang, MD, Hunan Cancer 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)

January 1, 2021

Primary Completion (Estimated)

June 15, 2025

Study Completion (Estimated)

September 15, 2025

Study Registration Dates

First Submitted

December 8, 2023

First Submitted That Met QC Criteria

December 8, 2023

First Posted (Actual)

December 18, 2023

Study Record Updates

Last Update Posted (Actual)

December 18, 2023

Last Update Submitted That Met QC Criteria

December 8, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EGFR 19 delins

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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