Epidermal Growth Factor Receptor (EGFR) Status Based Gefitinib Neoadjuvant Therapy in Non Small Cell Lung Cancer (NSCLC)

Phase 2

Suspended

• Conditions: Non Small Cell Lung Cancer
• Interventions: Drug: gefitinib

• Registration Number: NCT00986284
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

Brief Summary

This study aims to investigate the efficacy and safety of gefitinib as neoadjuvant therapy in stage IIIA NSCLC patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-27
• Study First Submitted QC: 2009-09-28
• Study First Posted: 2009-09-29
• Status Verified: 2012-08
• Last Update Submitted: 2015-12-21
• Last Update Posted: 2015-12-22
• Primary Completion: 2016-11
• Study Completion: 2016-11

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

• Patients pathological diagnosed with NSCLC,with EGFR sensitive mutation;
• Stage IIIA patients with technical operable disease evaluated by image and lab results;
• Patients without chemotherapy or targeted-therapy before;
• Inform Consent.

Exclusion Criteria

• Patients with malignant tumor other than lung cancer;
• Patients with other diseases such as cardiovascular disease that may hamper follow up;
• Patients that may not coordinate well,judged by researcher.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gefitinib, Neoadjuvant therapy	gefitinib	Patients with EGFR mutation will be recruited and treated with gefitinib.

Primary Outcome Measures

Name	Time	Method
Response Rate	1 month

Trial Locations

Locations (1)

Tianjin Cancer Institute & Hospital; 🇨🇳 Tianjin, Tianjin, China