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

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

Status

Suspended

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00986284

Enrollment

102

Registered

2009-09-29

Start date

2009-09-30

Completion date

2016-11-30

Last updated

2015-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Small Cell Lung Cancer

Keywords

Non Small Cell Lung Cancer, Gefitinib, Neoadjuvant Therapy

Brief summary

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

Interventions

DRUGgefitinib

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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Response Rate	1 month

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026