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

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ClinicalTrials.gov Identifier: NCT02738684
Recruitment Status : Unknown
Verified April 2016 by XIAOTIANDAI, Southwest Hospital, China.
Recruitment status was:  Not yet recruiting
First Posted : April 14, 2016
Last Update Posted : April 14, 2016
Sponsor:
Information provided by (Responsible Party):
XIAOTIANDAI, Southwest Hospital, China

Brief Summary:
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.

Condition or disease
Lung Adenocarcinoma

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 : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: 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
Study Start Date : April 2016
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Gefitinib

Group/Cohort
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



Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples With DNA
predict gefitinib' s efficacy for late stage lung adenocarcinoma patients by plasma free nucleic acids EGFR gene mutation test


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02738684


Contacts
Contact: WANG H J, doctor +86-23-65221360 cslz.fwjt@163.com

Sponsors and Collaborators
Southwest Hospital, China
Investigators
Principal Investigator: DAI X T, doctor Department of Respiratory Diseases, Souty West Hospital

Responsible Party: XIAOTIANDAI, Department of Respiratory Diseases, Southwest Hospital, China
ClinicalTrials.gov Identifier: NCT02738684     History of Changes
Other Study ID Numbers: pfnaegmt-023
First Posted: April 14, 2016    Key Record Dates
Last Update Posted: April 14, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by XIAOTIANDAI, Southwest Hospital, China:
lung cancer
adenocarcinoma
EGFR
plasma free nucleic acids

Additional relevant MeSH terms:
Adenocarcinoma
Lung Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Gefitinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action