the Clinical Trial of Gefitinib(Non - Small Cell Lung Cancer)

Evaluation of the Efficacy of Domestic Gefitinib Tablets in the Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer Patients Using a Multicenter, Randomized, Positive Drug Gefitinib Pharmacodynamics and Pharmacodynamics

1. Gefitinib CTTQ production gefitinib and erlotinib sheet AstraZeneca imatinib sheet (trade name: Iressa ®) comparison, human pharmacokinetics and relative bioavailability of comparative studies which examine people in vivo pharmacokinetic behavior, provide the basis for clinical use.
2. Evaluation CTTQ gefitinib imatinib sheet production efficacy and safety of Chinese patients with locally advanced or metastatic non-small cell lung cancer.

Study Overview

• Status: Unknown
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: Gefitinib Tab （CTTQ），First medication；Gefitinib Tab （CTTQ），From the 8th day of trial; Drug: Gefitinib Tab 250 MG（CTTQ），From the 8th day of trial.; Drug: Gefitinib tablets (Yi Ruisha），First medication

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients volunteered to participate in this study, signed informed consent;
2. ≥18 years old; ECOG PS score: 0 ~ 1; expected survival period of more than 3 months;
3. patients with locally advanced or metastatic non-small cell lung cancer diagnosed by histology or cytology, who can not receive radical surgery or radiotherapy; patients with measurable lesions(according to RECIST criteria);
4. Detection of EGFR-positive exon 19 deletion or exon 21 (L858R) mutation was performed by providing a detectable specimen (tissue or cancerous pleural effusion) prior to enrollment;
5. The main organ function within 7 days before treatment, meet the following criteria:

(1) blood routine examination criteria (14 days without blood transfusion): A) hemoglobin≥ 90g / L; B) neutrophil absolute ≥ 1.5 × 109 / L; C) platelet ≥80 × 109 / L (2) biochemical tests to meet the following criteria: A) total bilirubin ≤ 1.5 times the upper limit of normal (ULN); B) alanine aminotransferase and aspartate aminotransferase AST ≤ 2.5ULN, such as liver metastasis, ALT and AST ≤ 5ULN; C) serum creatinine ≤ 1.5ULN or creatinine clearance ≥ 60ml / min; (3) Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) ≥ normal low (50%).

6.Women of childbearing age should agree that contraceptive measures (such as intrauterine devices, birth control pills or condoms) must be used within the study period and within 6 months after the end of the study; serum or urine pregnancy test is negative within 7 days prior to enrollment, And must be non-lactating patients; men should agree to patients who have contraceptive use during the study period and six months after the end of the study period.

Exclusion Criteria:

1. patients who have previously used EGFR-TKI drugs;
2. small cell lung cancer (including small cell carcinoma and non-small cell carcinoma mixed lung cancer);
3. central type, with empty lung squamous cell carcinoma, or with non-small cell lung cancer with hemoptysis (> 50 ml / day) 4.5 years or at the same time with other malignancies, cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumor except [Ta (non-invasive tumor), Tis (carcinoma in situ ) And T1 (tumor infiltrating basement membrane)];

5.Whole-body antitumor therapy was planned within 4 weeks prior to randomization or during the course of this study, including cytotoxic therapy, signal transduction inhibitors, immunotherapy (or use of mitogen at 6 weeks prior to administration of the test drug) C); 6.patients with symptomatic or unstable brain metastases; 7.patients with any severe and / or uncontrolled disease, including: A) cirrhosis, acute or active hepatitis; B) history of immunodeficiency, including HIV-positive or other acquired, congenital immunodeficiency disease, or history of organ transplantation; C) patients with seizures and who need treatment; 8.active or uncontrollable serious infection (≥CTC AE Level 2 infection); 9.with a history of mental illness and can not quit or have mental disorders; 10.participated in other anti-tumor drug clinical trials within four weeks; 11.According to the judge's judgment, there is an impact on the absorption of oral drugs or serious harm to the safety of patients is not suitable for participation in the study of the situation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: trial group; Gefitinib tablets (CTTQ），First medication.From the 8th day of the experiment, treated with Gefitinib Tab（CTTQ）	Drug: Gefitinib Tab （CTTQ），First medication；Gefitinib Tab （CTTQ），From the 8th day of trial; Gefitinib Tab （CTTQ），First medication,250mg； Drug: Gefitinib Tab 250 MG（CTTQ），From the 8th day of trial.; From the 8th day of the experiment, two groups of subjects were treated with Gefitinib（CTTQ）
Active Comparator: control group; Gefitinib tablets (Yi Ruisha），First medication.From the 8th day of the experiment, treated with Gefitinib Tab（CTTQ）	Drug: Gefitinib Tab 250 MG（CTTQ），From the 8th day of trial.; From the 8th day of the experiment, two groups of subjects were treated with Gefitinib（CTTQ）; Drug: Gefitinib tablets (Yi Ruisha），First medication; Gefitinib tablets (Yi Ruisha），First medication,250mg；

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gefitinib plasma concentration	After the use of gefitinib to reach the highest plasma concentration	0hour before administration and 1, 2, 3, 4, 5, 6, 7, 8,9,13,24,48,72,120,168 16 hour time points after administration
Tmax time	Taking the time required for the concentration of gefitinib to reach the peak	0hour before administration and 1, 2, 3, 4, 5, 6, 7, 8,9,13,24,48,72,120,168 16 hour time points after administration
AUC0-t	The area between the axis of the coordinate and the time drug concentration curve	0hour before administration and 1, 2, 3, 4, 5, 6, 7, 8,9,13,24,48,72,120,168 16 hour time points after administration
t 1/2	The time required for gefitinib to decrease by half the highest concentration in plasma	0hour before administration and 1, 2, 3, 4, 5, 6, 7, 8,9,13,24,48,72,120,168 16 hour time points after administration
F	Gefitinib absorbs the relative amount of blood into the cycle	0hour before administration and 1, 2, 3, 4, 5, 6, 7, 8,9,13,24,48,72,120,168 16 hour time points after administration

Collaborators and Investigators

• Sponsor: Jiangsu Famous Medical Technology Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2017
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: July 3, 2017
• First Submitted That Met QC Criteria: August 28, 2017
• First Posted (Actual): August 29, 2017

Study Record Updates

• Last Update Posted (Actual): August 29, 2017
• Last Update Submitted That Met QC Criteria: August 28, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Gefitinib
• Other Study ID Numbers: CTTQ-20161017

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No