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Report for Clinical Trial NCT03382795

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Retreatment With 1st Generation EGFR TKIs in Sensitizing EGFR Mutation Positive Non-Squamous Cell Carcinoma Patients Who Previously Treated With EGFR TKI and Cytotoxic Chemotherapy

In this trial, treatment efficacy and safety of retreatment with 1st generation epidermal growth factor receptor(EGFR) tyrosine kinase inhibitor(TKI)s(Gefitinib/Erlotinib), will be assessed in patients with sensitizing EGFR mutation positive Non-Squamous Cell Carcinoma patients who previously treated with EGFR TKI and cytotoxic chemotherapy

NCT03382795 EGFR Positive Non-small Cell Lung Cancer
MeSH: Carcinoma, Non-Small-Cell Lung
HPO: Non-small cell lung carcinoma

1 Interventions

Name: EGFR

Description: Gefitinib 250mg or Erlotinib 150mg medication, Once-Daily.

Type: Drug

EGFR retreat group


Primary Outcomes

Description: Assessed on based of RECIST 1.1.

Measure: Objective Response Rate(ORR) including rage of CR&PR

Time: Through study completion (5 years)

Secondary Outcomes

Description: Progression-free survival (PFS) the time from first dose of the study drug until the date of disease progression or death by any cause

Measure: Progression Free Survival, PFS

Time: Through study completion (5 years)

Description: Overall Survival (OR) the time from first dose of the study drug until the date of death by any cause

Measure: Overall Survival

Time: Through study completion (5 years)

Description: Assessment on the base of NCI-CTCAE (version 4.03)

Measure: The incidence of Adverse Events(including Serious Adverse Events and Adverse Drug Reactions)

Time: Through study completion (5 years)

Purpose: Treatment

Single Group Assignment


There are 2 SNPs

SNPs


1 L858R

Inclusion Criteria: 1. Males or females ≥ 19 years of age 2. Non Small Cell Lung Cancer(Non-Squamous Cell Carcinoma) patients who had shown clinical benefits (Complete response(CR) or Partial response(PR) or Stable disease(SD) ≥6 months) from EGFR-TKIs as first line treatment and developed progressive disease, and then received cytotoxic chemotherapy more than 4 cycles and developed progressive disease, and then confirmed T790 negative and sensitizing EGFR mutation(E19Del, L858R, L861Q, G719X, E19insertion) positive in Histologic, cytologic specimen or blood. --- L858R ---

Patients who are difficult to include in this study in accordance with the investigator's judgment due to severe adverse effects during previous EGFR TKI treatment Inclusion Criteria: 1. Males or females ≥ 19 years of age 2. Non Small Cell Lung Cancer(Non-Squamous Cell Carcinoma) patients who had shown clinical benefits (Complete response(CR) or Partial response(PR) or Stable disease(SD) ≥6 months) from EGFR-TKIs as first line treatment and developed progressive disease, and then received cytotoxic chemotherapy more than 4 cycles and developed progressive disease, and then confirmed T790 negative and sensitizing EGFR mutation(E19Del, L858R, L861Q, G719X, E19insertion) positive in Histologic, cytologic specimen or blood. --- L858R ---


2 L861Q

Inclusion Criteria: 1. Males or females ≥ 19 years of age 2. Non Small Cell Lung Cancer(Non-Squamous Cell Carcinoma) patients who had shown clinical benefits (Complete response(CR) or Partial response(PR) or Stable disease(SD) ≥6 months) from EGFR-TKIs as first line treatment and developed progressive disease, and then received cytotoxic chemotherapy more than 4 cycles and developed progressive disease, and then confirmed T790 negative and sensitizing EGFR mutation(E19Del, L858R, L861Q, G719X, E19insertion) positive in Histologic, cytologic specimen or blood. --- L858R --- --- L861Q ---

Patients who are difficult to include in this study in accordance with the investigator's judgment due to severe adverse effects during previous EGFR TKI treatment Inclusion Criteria: 1. Males or females ≥ 19 years of age 2. Non Small Cell Lung Cancer(Non-Squamous Cell Carcinoma) patients who had shown clinical benefits (Complete response(CR) or Partial response(PR) or Stable disease(SD) ≥6 months) from EGFR-TKIs as first line treatment and developed progressive disease, and then received cytotoxic chemotherapy more than 4 cycles and developed progressive disease, and then confirmed T790 negative and sensitizing EGFR mutation(E19Del, L858R, L861Q, G719X, E19insertion) positive in Histologic, cytologic specimen or blood. --- L858R --- --- L861Q ---



HPO Nodes


HPO:
Non-small cell lung carcinoma
Genes 3
TP53 TP53 BAP1