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

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: Unknown
• Conditions: 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
• Enrollment (Anticipated): 100

Contacts and Locations

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RECIST 1.1 Efficacy assessments	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

• Sponsor: Southwest Hospital, China
• Investigators: Principal Investigator: DAI X T, doctor, Department of Respiratory Diseases, Souty West Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Anticipated): January 1, 2018
• Study Completion (Anticipated): January 1, 2018

Study Registration Dates

• First Submitted: March 22, 2016
• First Submitted That Met QC Criteria: April 13, 2016
• First Posted (Estimate): April 14, 2016

Study Record Updates

• Last Update Posted (Estimate): April 14, 2016
• Last Update Submitted That Met QC Criteria: April 13, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: lung cancer; EGFR; adenocarcinoma; plasma free nucleic acids
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Adenocarcinoma; Adenocarcinoma of Lung
• Other Study ID Numbers: pfnaegmt-023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes