SNPMiner Trials by Shray Alag

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Report for Clinical Trial NCT02526537

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

The Postoperative Adjuvant Therapy of Gefitinib for High Risk Stage Ib NSCLC Patients With EGFR Sensitive Mutation, an Open, Paired, Non-interventional, Multi-center Clinical Study

Currently, whether adjuvant therapy should be applied to Stage Ib non-small cell lung cancer (NSCLC) patients who received radical resection remains controversial. There is still no clear evidence that the postoperative adjuvant chemotherapy or other treatments can improve the survival rate for patients with stage Ib NSCLC. Tyrosine Kinase Inhibitors (TKIs) such as Gefitinib and Erlotinib are widely accepted as the first-line therapy for Epidermal growth factor receptor (EGFR) gene mutation late stage NSCLC patients. However the effect is largely uncertain for early stage patients who received surgery. The investigators aim to evaluate the effect of postoperative adjuvant use of Gefitinib for high risk stage Ib EGFR sensitive mutation NSCLC patients.

NCT02526537 NSCLC
MeSH:Carcinoma, Non-Small-Cell Lung
HPO:Non-small cell lung carcinoma

Primary Outcomes

Measure: Relapse Free Survival in 2 years

Time: Treatment period: 2 years (24 months)

Secondary Outcomes

Measure: Relapse Free Survival in 3 years

Time: Follow-up: 3 years

Measure: 5 year Overall Survival

Time: Follow-up: 5 years

Measure: Relapse Free Survival in 5 years

Time: Follow-up: 5 years

Time Perspective: Prospective


There are 2 SNPs


1 L858R

2. Patients with pathology confirmed Ib stage NSCLC 3. Patients with deletion of exon 19 or mutation of L858R at exon 21 in EGFR gene 4. ECOG score of 0-1 5. Life expectancy over 12 weeks 6. --- L858R ---

2 T790M

Patients with T790M mutations at 20 exon; 18. Woman who are pregnant or lactating. --- T790M ---

HPO Nodes