Clinical trial NCT02347839: NEoadjuvant Gefitinib fOllowed by Surgery and gefiTinib In unresectAble sTage III NSCLC With EGFR Mutations.
Official title: A Multicenter Phase II Trial of Neoadjuvant Gefitinib Followed by Surgery, Followed by Adjuvant Gefitinib in Patients With Unresectable Stage III Non-Small Cell Lung Cancer Harboring Activating Epidermal Growth Factor Receptor Mutations.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Lung Cancer
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2015-01-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to studying neoadjuvant gefitinib followed by surgery, followed by adjuvant gefitinib to see how well it works in treating patients with unresectable stage III NSCLC harboring EGFR mutations.

Detailed description: Concurrent chemoradiotherapy is the recommended therapeutic approach for patients with unresectable stage III non-small cell lung cancer (NSCLC), although surgery offers the chance of cure. With combined-modality therapy with radiation therapy and chemotherapy, the prognosis of stage III NSCLC remains poor. Gefitinib has shown great efficacy in NSCLC patients with EGFR mutations. This study is to studying neoadjuvant gefitinib followed by surgery, followed by adjuvant gefitinib to see how well it works in treating patients with unresectable EGFR mutant stage III NSCLC.

Eligibility criteria: Inclusion Criteria:

* Target population is unresectable stage III (III A-bulky N2, III B) NSCLC with EGFR activating mutation in exon 19 or 21
* Written informed consent provided
* Aged 18-75 years
* Able to comply with the required protocol and follow-up procedures
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* Had a life expectancy of 12 weeks or more
* Adequate hematological function, liver function and renal function
* Female participants should not be pregnant or breast-feeding

Exclusion Criteria:

* Known severe hypersensitivity to gefitinib or any of the excipients of this product
* Inability to comply with protocol or study procedures
* Had had previous chemotherapy, radiotherapy, or agents directed at the HER axis (e.g. erlotinib, gefitinib, cetuximab, trastuzumab)
* Had a history another malignancy in the last 5 years with the exception of cured basal cell carcinoma of the skin, cured in situ carcinoma of the uterine cervix and cured epithelial carcinoma of the bladder
* Interstitial pneumonia
* Eye inflammation not fully controlled or conditions predisposing the subject to this
* Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease)
* Known human immunodeficiency virus (HIV) infection
* Pregnancy or breast-feeding women
* History of neurologic or psychiatric disorders
* Ingredients mixed with small cell lung cancer patients

Primary outcomes:
measure: Resectability rate
timeFrame: 3 months
Secondary outcomes:
measure: Number of participants with perioperative complications
timeFrame: 1 year
measure: Event-free survival
timeFrame: 2 years after the last patient is randomized
measure: Overall survival
timeFrame: 2 years after the last patient is randomized
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Guangdong Province Association Study of Thoracic Oncology
name: Si-Yu Wang
role: PRINCIPAL_INVESTIGATOR
References: