A Study to Predict Gefitinib' s Efficacy for Lung Cancer by Plasma Free Nucleic Acids EGFR Gene Mutation Test

April 13, 2016 updated by: XIAOTIANDAI, Southwest Hospital, China

A Small Sample Exploratory Study to Predict Gefitinib' s Efficacy for Late Stage Lung Adenocarcinoma Patients by Plasma Free Nucleic Acids EGFR Gene Mutation Test

This project aims to do a small sample exploratory study, to predict EGFR-TKI targeted therapy gefitinib' s efficacy in late stage lung adenocarcinoma patients (phase IIIB or IV), who have negative tissue EGFR gene mutation, positive plasma free nucleic acid EGFR gene.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Results of the study will clarify that if the circulating tumor DNA (ctDNA) EGFR mutation could be used as a screening method for EGFR-TKI targeted therapy for late stage lung cancer patients, as well as a standard for the therapy efficacy. This study can be used as a standard to assess gefitinib' s efficacy after 8 weeks of treatment in IIIB or stage IV lung cancer through tumor tissue negative, ctDNA positive EGFR mutation.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Participants in this research must meet the following criteria: histologic diagnosed of lung adenocarcinoma. Late stage (stage IIIB or IV) lung adenocarcinoma according to the International Union against cancer (UICC) the latest version of standard cancer TNM staging.

Description

Inclusion Criteria:

  • Participants in this research must meet the following criteria: histologic diagnosed of lung adenocarcinoma.
  • Late stage (stage IIIB or IV) lung adenocarcinoma according to the International Union against cancer (UICC) the latest version of standard cancer TNM staging.
  • tumor tissue EGFR mutation negative, and ctDNA EGFR mutation positive correlated with EGFR TKI sensitivity.
  • Participants should have signed and dated on the official informed consent.
  • Not less than 18 years old.
  • At least 1 lesion can be exactly measured.
  • Patients whose plasma free nucleic acids EGFR mutation test were positive, and willing to use gefitinib for therapy by their own expense.

Exclusion criteria:

  • Patients already received EGFR-TKI treatment previously.
  • Patients have pressure on the spinal cord or brain metastases, no symptom, conditions stabled, do not need to use steroid medications for 4 weeks before the start of the study.
  • Patients with clinical evidence of any symptoms of severe or uncontrolled hypertension, for example, researchers believe that patients with uncontrolled hypertension and active bleeding will affect the study reliability.
  • Patients with uncontrolled nausea or vomiting, chronic gastrointestinal disease, unable to swallow drugs or underwent major bowel resection may affect the full absorption of gefitinib.
  • Patients meet any one of the following heart standard: in static State, 3 times ECG check shows average correction QT period (QTc) >470 msec; clinical abnormal symptom of rhythm, conduction, and static ECG, for example completely left beam conduction block, III degrees conduction block, II degrees conduction block, PR period >250 msec, various factors with risks of extended QTc or rhythm disorders, for example, congestive heart failure, low potassium blood syndrome, congenital long QT Syndrome, direct relatives has long QT syndrome or sudden unexplained death in less than 40 years old, drug combination that may prolong the QT interval.
  • Patients Have the following history: ILD, drug-induced ILD, radiation Pneumonitis require steroid treatment, clinically active interstitial lung disease.
  • Abnormal marrow reservation or organ function.
  • Women who are breastfeeding.
  • Fertile male or female, who did not taken effective contraceptive measures, women have been pregnant or breast feeding, or positive pregnancy test prior to study (urine or serum).
  • Patients don't agree with the study processes, constraints and requirements, and were evaluated by researchers that can't participate in the study.

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: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
lung cancer
A small sample exploratory study to predict gefitinib' s efficacy for late stage lung adenocarcinoma patients by plasma free nucleic acids EGFR gene mutation test

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
RECIST 1.1 Efficacy assessments
Time Frame: 8 weeks
Categorisation of objective tumour response assessment at each visit will be based on the RECIST 1.1 criteria of response: CR, PR, SD and PD.
8 weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Southwest Hospital, China

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: DAI X T, doctor, Department of Respiratory Diseases, Souty West 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 22, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 14, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 14, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • pfnaegmt-023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

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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