NCT01843647

Neoadjuvant Therapy of Icotinib in Epidermal Growth Factor Receptor Mutated NSCLC Patients

Randomized, Controlled, Multicenter Study of Neoadjuvant Therapy With Icotinib in IIIA NSCLC Patients With Epidermal Growth Factor Receptor Mutation

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Betta Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the overall response rate and disease free survival for IIIAN2 non-small-cell lung cancer patients with EGFR 19 or 21 exon mutation.

Detailed description

Neoadjuvant therapy has been used for years to treat patients with non-small-cell lung cancer whose primary tumors are too large to allow for surgery. Reduction in size of the primary tumor with neoadjuvant therapy has made it possible for those patients. Moreover, the goals have expanded to include: determination of the sensitivity of the tumor so that subsequent therapy can be modified accordingly; to prolong disease free survival; to prolong survival.

Conditions

• Non-small-cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Icotinib	Patients receive 8-week icotinib induction treatment before surgery and 1-year icotinib adjuvant therapy after surgery.Icotinib is administered orally with a dose 125 mg 3 times daily.
DRUG	Chemotherapy	After surgery patients receive 4-cycle adjuvant chemotherapy with vinorelbine /cisplatin regimen, until untolerable toxicity or disease progression.

Timeline

• Start date: 2013-04-01
• Primary completion: 2016-12-01
• Completion: 2018-02-01
• First posted: 2013-04-30
• Last updated: 2015-07-15

Locations

1 site across 1 country: China