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Report for Clinical Trial NCT01833572

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Single-arm, Phase II Study of Preoperative Gefitinib for Stage II-IIIa NSCLC With Activating EGFR Mutation

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.

NCT01833572 Non-small-cell Lung Cancer
MeSH:Carcinoma, Non-Small-Cell Lung
HPO:Non-small cell lung carcinoma

1 Interventions

Name: Gefitinib

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.
Type: Drug
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

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 T790M

Patients who harbouring exon 20 T790M mutation. --- T790M ---



HPO Nodes


HPO: