NCT02820116

The Role of Icotinib in the Perioperative Treatment of IIIA - IIIB NSCLC Patients With EGFR Mutation

An Open-label, Multicenter，Single-arm, Phase II Clinical Study of Icotinib for IIIA - IIIB NSCLC Patients With Epidermal Growth Factor Receptor Mutation

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 67 (estimated)
• Sponsor: Beijing Haidian Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, multicenter, single-arm, phase II interventional clinical trial evaluating efficacy and safety of Icotinib as neoadjuvant treatment in patients with IIIA- IIIB NSCLC with activating EGFR mutation in exon 19 or 21. Sixty-seven resectable stage IIIA- IIIB 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. Neoadjuvant treatment phase: Eligible patients will receive 125mg of Icotinib three times per day. Treatment will be scheduled to continue until the disease progression or unbearable toxicities appear. Surgery treatment phase: Tumor response will be evaluated with CT scan after 8 weeks of induction treatment. The patients with responsive disease considered to be technique resectable will undergo resection. Post-surgery phase: It is the discretion of the investigator whether the patient is a candidate for post-operative treatment which is considered to be in the best interest of the patients. It is recommended that patients with positive margins or residual tumor after surgery should receive radiation therapy. Patients after surgery will receive long-term follow-up -- chest CT scan，abdominal abdominal ultrasound every 3 months, brain MRI every 6 months, bone scan (ECT) every 12 months -- for up to 5 years.

Conditions

• Non-small Cell Lung Cancer(NSCLC)

Interventions

Type	Name	Description
DRUG	Icotinib	In the neoadjuvant treatment phase, eligible patients will receive 125mg of Icotinib three times per day for 8 weeks (56 days). In the post-surgery phase, Icotinib 125mg/three tims/day taken orally for 2 years or till disease progression or unacceptable toxicity.

Timeline

• Start date: 2016-05-01
• Primary completion: 2023-04-01
• Completion: 2023-04-01
• First posted: 2016-06-30
• Last updated: 2016-06-30

Locations

1 site across 1 country: China