Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has suspended participant recruitment.
(Lack of patients and some progressed disease soon after surgery)
Information provided by (Responsible Party):
Tianjin Medical University Cancer Institute and Hospital Identifier:
First received: September 27, 2009
Last updated: November 26, 2013
Last verified: August 2012

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

Condition Intervention Phase
Non Small Cell Lung Cancer
Drug: gefitinib
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of EGFR Status Based Gefitinib Neoadjuvant Therapy in NSCLC Patients

Resource links provided by NLM:

Further study details as provided by Tianjin Medical University Cancer Institute and Hospital:

Primary Outcome Measures:
  • Response Rate [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: September 2009
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gefitinib, Neoadjuvant therapy
Patients with EGFR mutation will be recruited and treated with gefitinib.
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.
Other Name: Iressa


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00986284

China, Tianjin
Tianjin Cancer Institute & Hospital
Tianjin, Tianjin, China, 300060
Sponsors and Collaborators
Tianjin Medical University Cancer Institute and Hospital
Study Director: Changli Wang, MD Tianjin Medical University Cancer Institute and Hospital
  More Information

No publications provided

Responsible Party: Tianjin Medical University Cancer Institute and Hospital Identifier: NCT00986284     History of Changes
Other Study ID Numbers: TMU-CIH-LCC-001
Study First Received: September 27, 2009
Last Updated: November 26, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Tianjin Medical University Cancer Institute and Hospital:
Non Small Cell Lung Cancer
Neoadjuvant Therapy

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses processed this record on February 27, 2015