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Report for Clinical Trial NCT01833572
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
This is an open-label, single-arm, phase II interventional clinical trial. The investigators
hypothesize that the application of EGFR-TKI, like gefitinib will be efficient and safe in a
neo-adjuvant setting. 42 resectable stage II-IIIa NSCLC patients with EGFR activating (19/21)
mutations will be eligible to be enrolled. EGFR mutation will be prospectively tested in all
the participants' biopsy samples and confirmed in surgical resected samples. Eligible
patients will be given gefitinib 250mg for 42days followed with surgical resection of tumor.
Efficacy of preoperative gefitinib is based on radiographic (CT response/ORR), pathologic
(pathologic response), surgical (complete resection) evaluations, and safety is based on
adverse effect evaluations.
Description: Eligible participants will be given orally gefitinib 250mg daily before surgery for 42 days or until disease progression or unacceptable toxicity. Best supportive care is allowed in this period.
Group Labels: 1 Gefitinib
Primary Outcomes Measure: Objective response rate (ORR) Time: at day 42 of gefitinib treatment
Secondary Outcomes Measure: Pathologic response rate Time: Pathologic response rate is depended on the pathology dignosis after surgery, an expected average of 8 weeks from enrollment.
Measure: Complete resection rate Time: Complete resection rate is depended on the pathology dignosis after surgery, an expected average of 8 weeks from enrollment.
Measure: Number of participants with adverse events Time: During the neoadjuvant and perioperative period, an expected average of 10 weeks from enrollment
Measure: Quality of life (QoL) Time: During the neoadjuvant period, an expected average of 6 weeks from enrollment
Measure: Disease free survival (DFS) Time: Participants after surgery will receive long-term follow-up for up to 5 years
Measure: Overall survival (OS) Time: Participants after surgery will receive long-term follow-up for up to 5 years
Single Group Assignment
There is one SNP
Patients who harbouring exon 20 T790M mutation. --- T790M ---