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Report for Clinical Trial NCT03264794

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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.

NCT03264794 Non-small Cell Lung Cancer
MeSH:Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO:Neoplasm of the lung Non-small cell lung carcinoma

3 Interventions

Name: Gefitinib Tab (CTTQ),First medication;Gefitinib Tab (CTTQ),From the 8th day of trial

Description: Gefitinib Tab (CTTQ),First medication,250mg;
Type: Drug
Group Labels: 1

trial group

Name: Gefitinib tablets (Yi Ruisha),First medication

Description: Gefitinib tablets (Yi Ruisha),First medication,250mg;
Type: Drug
Group Labels: 1

control group

Name: Gefitinib Tab 250 MG(CTTQ),From the 8th day of trial.

Description: From the 8th day of the experiment, two groups of subjects were treated with Gefitinib(CTTQ)
Type: Drug
Group Labels: 2

control group trial group


Primary Outcomes

Description: After the use of gefitinib to reach the highest plasma concentration

Measure: Gefitinib plasma concentration

Time: 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

Description: Taking the time required for the concentration of gefitinib to reach the peak

Measure: Tmax time

Time: 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

Description: The area between the axis of the coordinate and the time drug concentration curve

Measure: AUC0-t

Time: 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

Description: The time required for gefitinib to decrease by half the highest concentration in plasma

Measure: t 1/2

Time: 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

Description: Gefitinib absorbs the relative amount of blood into the cycle

Measure: F

Time: 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

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 L858R

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. --- L858R ---



HPO Nodes


HPO: