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

Non Small Cell Lung Cancer Clinical Trial

Official title:

Phase II Study of EGFR Status Based Gefitinib Neoadjuvant Therapy in NSCLC Patients

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00986284
• Other study ID #: TMU-CIH-LCC-001
• Status: Suspended
• Phase: Phase 2
• First received: September 27, 2009
• Last updated: December 21, 2015
• Start date: September 2009
• Est. completion date: November 2016

Study information

• Verified date: August 2012
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 102
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Drug:
• gefitinib
Patients with EGFR mutation in exon 19 or 21 will be administrated with gefitinib as neoadjuvant therapy. Then evaluated for response and then operation for operable patients.

Locations

Country	Name	City	State
China	Tianjin Cancer Institute & Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response Rate		1 month	No